FDA Drug Labeler Code
Registration Services
An FDA Drug Labeler Code is the unique 5- or 6-digit identifier the U.S. Food and Drug Administration assigns to any firm — manufacturer, repacker, relabeler, private label brand owner, or distributor — that places a drug product into U.S. commerce under its own name. It is assigned under 21 CFR 207.33 as part of the FDA's drug listing system and forms the first segment of every NDC (National Drug Code) printed on your product label. The Labeler Code identifies who is legally responsible for the drug — without it, no NDC can be issued and no drug product can be lawfully listed with the FDA. Selling a drug in the U.S. without a valid Labeler Code is misbranding under FD&C Act §502(o), triggering FDA warning letters, import refusal, and removal from Amazon, Shopify, and Walmart.
Any firm whose name appears on a drug product label distributed in the U.S. must obtain an FDA Drug Labeler Code under 21 CFR 207.33 before NDC numbers can be assigned. FDA Registration Assistance prepares your SPL Labeler Code application, files it through CDER Direct, and delivers your assigned code — accurately and in full compliance.
What Is an FDA Drug Labeler Code & Why Does Every Drug Company Need One?
An FDA Drug Labeler Code is a unique 5- or 6-digit number assigned by the FDA under 21 CFR 207.33 to identify the firm responsible for placing a drug product into U.S. commerce. Whether you manufacture the product, repack it, relabel it, or simply sell it under your own brand name as a private labeler, the FDA needs to know who you are — and the Labeler Code is that identifier. It is the foundation of the National Drug Code (NDC) system: without an active Labeler Code, no NDC can be assigned and no drug product can be lawfully listed with the FDA.
FDA Registration Assistance prepares your Labeler Code application in FDA Structured Product Labeling (SPL) XML format, submits it through CDER Direct via the FDA Electronic Submissions Gateway, monitors review status, and delivers your assigned Labeler Code with full documentation — typically in approximately 10 business days from FDA acceptance.
- Required before any NDC can be assigned to your drug products
- Applies to manufacturers, repackers, relabelers & private label brand owners
- Must be submitted in SPL format through CDER Direct — no paper form exists
- Tied to your legal company name, physical address & DUNS number
Drug Labeler Code Application & Compliance Services
Everything drug companies need to obtain a Labeler Code correctly and stay fully FDA-compliant.
SPL Labeler Code Application
FDA Registration Assistance prepares your complete Labeler Code request in Structured Product Labeling (SPL) XML format — with all required company, DUNS, and contact fields validated against FDA submission rules before filing.
CDER Direct Submission
We submit your Labeler Code request through CDER Direct via the FDA Electronic Submissions Gateway — the only valid channel — and confirm successful acknowledgment from the FDA review queue.
FDA Confirmation & Code Delivery
Once FDA assigns your Labeler Code, we capture the confirmation, verify it against the FDA NDC Directory, and deliver clean PDF documentation showing your assigned 5- or 6-digit code ready for NDC assignment.
Compliance Updates & Maintenance
Company name, address, ownership, or contact changes must be reported to the FDA via SPL updates. FDA Registration Assistance provides ongoing support to keep your Labeler Code record accurate and active.
Trusted FDA Drug Labeler Code Partner
Helping drug companies obtain Labeler Codes correctly — accurately, efficiently, and in full compliance with 21 CFR 207.33.
How Our FDA Drug Labeler Code Service Works
A simple four-step process to obtain your Labeler Code and unlock NDC assignment for your drug products.
Submit Company Information
Provide your legal company name, physical street address, DUNS number, and contact person. FDA Registration Assistance reviews everything for SPL submission readiness.
SPL Labeler Code Request Filed
We prepare your Labeler Code request in SPL XML format and submit it through CDER Direct via the FDA Electronic Submissions Gateway, confirming successful acknowledgment.
FDA Confirmation & Code Assigned
The FDA reviews the submission and assigns your unique 5- or 6-digit Labeler Code — typically in approximately 10 business days from acceptance.
Ongoing Compliance Support
FDA Registration Assistance handles any FDA clarification requests, delivers your final documentation, and manages updates if your company information changes.
What Every Labeler-of-Record Must Do
Under 21 CFR 207.33 and the broader drug listing regulations, every firm holding an FDA Drug Labeler Code carries a set of concrete compliance duties — failure on any one of them can render the underlying NDCs invalid.
Submit a Complete SPL Labeler Code Request
File a Labeler Code request in SPL XML format containing the legal company name, physical street address, valid DUNS number, contact person, and the firm's relationship to the drug (manufacturer, repacker, relabeler, or private label distributor).
Maintain a Verifiable Physical Address
The Labeler Code is bound to a real, verifiable U.S. or foreign street address — P.O. Boxes, virtual offices, and mail-forwarding services are not acceptable. The address must match the underlying DUNS record on file with Dun & Bradstreet.
Use the Labeler Code Correctly on Every NDC
The assigned Labeler Code must appear as the first segment of every NDC issued for the firm's drug products. Mixing or reusing another firm's Labeler Code is prohibited and triggers misbranding under FD&C Act §502(o).
Report Company Information Changes
Changes to legal name, physical address, ownership, contact person, or DUNS information must be reported to the FDA through an SPL update so the Labeler Code record remains accurate — the code itself stays the same.
Respond to FDA Clarification Requests
If the FDA issues a request for additional information during SPL review, the labeler must respond promptly. Failure to respond results in rejection of the Labeler Code request and forces a complete resubmission.
Never Represent the Code as FDA Approval
21 CFR 207.77 explicitly prohibits any claim, statement, or implication that having a Labeler Code or NDC constitutes FDA approval, endorsement, or evaluation of the drug. Marketing that claims "FDA-approved" based on a Labeler Code is misbranding.
Coordinate With Establishment Registration
For firms that also manufacture, repack, or relabel the drug, the Labeler Code must be cross-referenced with the appropriate FDA Establishment Identifier (FEI) in the drug listing — ensuring the labeler-of-record and the producing facility are properly linked.
Drug Labeler Code vs. Drug Establishment Registration
These two FDA registrations are routinely confused — but they identify completely different things. The Labeler Code identifies the firm whose name is on the label; the Establishment Registration identifies the physical facility that makes or handles the drug.
| Attribute | Drug Labeler Code | Drug Establishment Registration |
|---|---|---|
| Who Designates It | The FDA, in response to an SPL Labeler Code request from the labeler-of-record | The FDA, in response to an SPL establishment registration filed by the facility owner |
| What It Represents | The firm whose name appears on the drug product label (the "labeler-of-record") | The physical facility that manufactures, repacks, or relabels the drug product |
| Required By | FD&C Act §510 — for any firm placing a drug into U.S. commerce under its own name | FD&C Act §510 — for any establishment producing, repacking, or relabeling drugs for the U.S. |
| Governing Regulation | 21 CFR 207.33 | 21 CFR Part 207 (Subparts B–F) |
| Primary Function | Provides the 5- or 6-digit identifier that forms the first segment of every NDC | Provides the FEI number used for FDA inspection, import oversight, and supply-chain tracking |
| Required For | NDC assignment, drug listing, and lawful sale of any drug under the company's brand | FDA inspections, import clearance, GMP oversight, and post-market surveillance |
A Drug Labeler Code and a Drug Establishment Registration solve completely different problems. The Labeler Code says "this is the company legally responsible for the product on the shelf" — it is the firm whose name appears on the bottle, blister pack, or carton. The Establishment Registration says "this is the physical facility where the drug is made, repacked, or relabeled." A private label brand owner who outsources all manufacturing needs only a Labeler Code; a contract manufacturer who makes products for many brands needs an Establishment Registration but typically no Labeler Code; and a vertically integrated drug maker needs both. Most regulated businesses ultimately maintain Labeler Code ($349) + Establishment Registration ($449/year) + NDC Code per product ($199) for full compliance.
Self-Filing vs. FDA Registration Assistance
CDER Direct is open to the public — but the Labeler Code request requires SPL XML, DUNS validation, and HL7 schema compliance. Here is what the trade-off looks like.
| Factor | Self-Filing (DIY) | Recommended FDA Registration Assistance |
|---|---|---|
| Cost | $0 government fee + internal staff time, SPL software, validation tooling, and rework | $349 USD — flat fee covering SPL build, submission, monitoring & confirmation |
| Availability | You handle every FDA acknowledgment, clarification request, and rejection notice yourself | Dedicated regulatory team monitors the CDER Direct queue and FDA inbox on your behalf |
| Domain Expertise | Requires self-study of 21 CFR 207.33, SPL XML schemas, DUNS validation rules, and CDER Direct mechanics | 15+ years of SPL Labeler Code filings — manufacturers, repackers, private labelers, OTC monograph brands |
| Risk of Failure | High — DUNS mismatches, invalid address types, malformed XML, and missing relationship fields cause rejection | Pre-submission audit catches errors before filing; clarification requests handled at no extra charge |
| Confirmation & Handling | You must parse FDA XML acknowledgments and verify the assigned code in the NDC Directory yourself | Labeler Code verified in the FDA NDC Directory and delivered as clean PDF documentation |
| Renewal & Update Tracking | You must remember to file SPL updates for any company name, address, or contact change | Ongoing support for company-information updates and downstream NDC assignment |
A Drug Labeler Code request looks simple on paper — name, address, DUNS, contact — but the SPL XML format, FDA HL7 schema validation, and CDER Direct workflow are where most self-filers fail. Mismatched DUNS records, P.O. Box addresses, missing relationship fields, and malformed XML routinely cause rejection, forcing a full resubmission that delays NDC assignment and product launch. FDA Registration Assistance has run this filing thousands of times and handles every clarification request as part of the flat $349 fee.
Free / Friend Filing vs. FDA Registration Assistance
You can technically have anyone submit your Labeler Code request — but the code is bound to the legal entity in the SPL, and a wrong filing can give the Labeler Code to the wrong company.
| Factor | Free / Friend Filing | Recommended FDA Registration Assistance |
|---|---|---|
| Government Fee | $0 — the FDA does not charge for Labeler Code assignment itself | $0 government fee + $349 service (SPL build, submission, monitoring & confirmation) |
| Pros | No out-of-pocket cost if you already have a friend with an FDA Direct account and SPL experience | Filed in your legal entity's name, with your DUNS, verified in the FDA NDC Directory, fully documented |
| Cons | If the friend uses their own DUNS or company name, the Labeler Code legally belongs to them — not to you. Recovering it requires a new SPL filing and may force you to obtain a new code under your own entity. | Predictable cost, no risk of code being assigned to the wrong legal entity, FDA clarifications handled by professionals |
| Best For | No realistic business case — the Labeler Code must be tied to the firm whose name appears on the drug label | Every U.S. and foreign company that places a drug product into U.S. commerce under its own brand name |
A "free" Labeler Code filing by an unrelated party is one of the most common ways small drug brands lose control of their FDA records. Because the Labeler Code is permanently bound to the legal entity, DUNS, and address in the SPL submission, a friend filing on your behalf can — accidentally or otherwise — register the code under the wrong company. Recovering or transferring it can take weeks and may require obtaining a new code entirely. A professional filing under your verified entity prevents this from day one.
Drug Labeler Code Terms You Will Encounter
A quick reference of the technical acronyms, codes, and submission systems used throughout the FDA Drug Labeler Code process.
The 5- or 6-digit identifier the FDA assigns to a firm under 21 CFR 207.33. It forms the first segment of every NDC and identifies the company legally responsible for the drug on the label.
A 10- or 11-digit product identifier composed of three segments: Labeler Code + Product Code + Package Code. Every commercially distributed drug in the U.S. must have an NDC.
The firm whose name appears on the drug product label as the responsible entity. This is the company that must hold the Labeler Code — not necessarily the manufacturer.
The XML-based HL7 standard the FDA requires for electronic submission of Labeler Code requests, establishment registrations, and drug listings. All filings must validate against the current SPL schema.
The FDA online portal operated by the Center for Drug Evaluation and Research used to submit Labeler Code requests and SPL drug listings.
The FDA Electronic Submissions Gateway — the secure transport layer that transmits SPL submissions to FDA review queues.
A nine-digit unique identifier issued by Dun & Bradstreet that the FDA uses to verify the legal identity and physical address of every Labeler Code applicant.
FDA Establishment Identifier — the 7- to 10-digit number assigned to a physical drug facility. Different from a Labeler Code; the two often coexist for the same company.
A firm that sells a drug product under its own brand name without manufacturing it. Private label distributors must hold their own Labeler Code under 21 CFR 207.33.
A firm that repackages or relabels finished drug products. Repackers and relabelers typically need both a Labeler Code (for the relabeled product) and an Establishment Registration (for the physical site).
The FDA's public database of listed drug products — searchable by Labeler Code, labeler name, or NDC. The system of record for verifying a Labeler Code is real and active.
The regulatory pathway under which a drug is marketed (NDA, ANDA, BLA, OTC monograph, etc.). Declared in the SPL and downstream NDC listings; not the Labeler Code request itself.
Why Drug Labeler Code Requests Get Rejected
After 15+ years of SPL Labeler Code filings, these are the most frequent root causes of FDA rejection, RFI hold, or downstream NDC assignment failure.
Mismatched DUNS & Company Name
The FDA validates the SPL submission against the Dun & Bradstreet record in real time. Any mismatch in legal name, doing-business-as, or physical address between the SPL and the DUNS record causes automatic rejection.
P.O. Box or Virtual Office Address
21 CFR 207 requires the firm's actual physical street address. P.O. Boxes, virtual offices, mailbox services, and freight forwarder addresses are routinely rejected during SPL review.
SPL XML Validation Errors
Malformed XML, missing required HL7 elements, incorrect schema version, or invalid OIDs cause CDER Direct to reject the submission before FDA even reviews it. Self-filers often do not realize the SPL never reached the queue.
Missing or Wrong Relationship Field
The SPL must specify the firm's relationship to the drug — manufacturer, repacker, relabeler, or private label distributor. Choosing the wrong category, or leaving the field blank, triggers an FDA request for clarification.
Filed Under the Wrong Legal Entity
If a friend, agent, or unrelated party files the SPL using their own DUNS or company name, the assigned Labeler Code belongs to them — not to the brand owner. Recovering ownership requires a new SPL filing.
Ignoring FDA Clarification Requests
When the FDA emails a clarification request during review, failure to respond within the requested timeframe causes the entire Labeler Code request to be rejected — and you must resubmit from scratch.
Claiming "FDA-Approved" Based on the Code
21 CFR 207.77 explicitly prohibits stating or implying that a Labeler Code or NDC represents FDA approval. Marketing copy that claims "FDA-approved" because the firm has a Labeler Code is misbranding under §502(a) of the FD&C Act.
Not Updating After Ownership or Name Change
When a company is acquired, renamed, or relocated, the Labeler Code record must be updated through a new SPL submission. Failure to update the record can invalidate downstream NDC listings and trigger compliance issues.
Complete FDA Drug Registration Solutions
We offer a full range of FDA registration and compliance services to help your facility and shipments meet all U.S. regulatory requirements.
Drug Establishment Registration
Register your foreign or domestic drug manufacturing, repacking, or relabeling facility with the FDA — $449/year, U.S. Agent included.
Labeler Code Registration
Obtain your FDA Labeler Code — required to identify your company on drug product labels and NDC numbers distributed in the United States.
NDC Code / Product Code
Register your National Drug Code (NDC) and product codes with the FDA — $199 per product, mandatory for all U.S. drug products.
Drug Label & Ingredient Review
Ensure your drug product labels and ingredient declarations meet all FDA labeling requirements before entering the U.S. market.
DUNS Request Assistance
Obtain your DUNS Number required for FDA Drug Establishment Registration and Labeler Code applications — filed accurately on your behalf.
Drug / OTC U.S. Agent Services
Designate a U.S. FDA Agent for your foreign drug establishment — legally required for all foreign drug facilities registered with the FDA.
FDA Drug Listing Certificate
Obtain your official FDA Drug Listing Certificate confirming your drug product is registered and listed with the U.S. Food and Drug Administration.
FDA Drug Master Files (DMF)
Submit an FDA Drug Master File (DMF) to protect confidential manufacturing information while supporting drug product applications and registrations.
Drug Import Alert Removal
Get expert help resolving FDA drug import alerts and detentions to restore your drug products' ability to enter the United States.
Frequently Asked Questions About FDA Drug Labeler Codes
Find answers to the most common questions about FDA Drug Labeler Codes, the SPL application process, and how FDA Registration Assistance gets your code assigned quickly and correctly.
What is an FDA Drug Labeler Code?
An FDA Drug Labeler Code is a unique 5- or 6-digit number assigned by the FDA to any firm that manufactures, repacks, relabels, or distributes a drug product under its own name in the United States. It forms the first segment of every NDC and identifies the labeler responsible for the product.
Who is required to obtain a Drug Labeler Code?
Any firm whose name appears on the label of a drug product distributed in the U.S. — including manufacturers, repackers, relabelers, private label distributors, and OTC monograph brand owners — must obtain a Labeler Code from the FDA before NDC numbers can be assigned to their products.
How is the Labeler Code different from an NDC?
The Labeler Code is the company identifier. The NDC is the full 10- or 11-digit product identifier composed of three segments — Labeler Code + Product Code + Package Code. You need the Labeler Code first; only then can NDCs be assigned to your specific products.
Is a separate Labeler Code required for each drug product?
No. One Labeler Code covers an entire company. Every product the company labels uses the same Labeler Code as the first segment of its NDC. Only the Product Code and Package Code segments change between products.
What regulation governs Drug Labeler Code assignment?
Drug Labeler Codes are assigned under 21 CFR 207.33 as part of the FDA's drug listing requirements established by Section 510 of the Federal Food, Drug, and Cosmetic Act.
How is the Labeler Code application submitted to the FDA?
The application is submitted in Structured Product Labeling (SPL) XML format through the FDA's CDER Direct portal and transmitted via the FDA Electronic Submissions Gateway. There is no paper or web form option.
Is a DUNS number required to apply for a Drug Labeler Code?
Yes. The FDA requires a valid DUNS number tied to the legal company name and physical address before a Labeler Code can be assigned. The DUNS record is cross-checked against the SPL submission for verification.
How long does it take the FDA to assign a Labeler Code?
Typical FDA processing for a complete, properly formatted SPL Labeler Code application is approximately 10 business days from acceptance, though timing varies with FDA workload and any requests for additional information.
Does a Labeler Code expire or require annual renewal?
No. The Labeler Code itself does not expire and has no annual renewal fee. However, the company's drug establishment registration and drug listings must be renewed annually, and any changes to company name, ownership, or address must be reported to the FDA.
Can foreign companies obtain a Drug Labeler Code?
Yes. Foreign drug establishments and foreign private labelers can and must obtain a Labeler Code before placing drugs into U.S. commerce under their own brand. A U.S. Agent is required for foreign drug establishments.
What information must be included in a Labeler Code SPL application?
The SPL must include the legal company name, physical street address, DUNS number, contact person, telephone, email, and the relationship to the drug product (manufacturer, repacker, relabeler, or private label distributor).
Can I get an NDC without a Labeler Code?
No. NDCs cannot be assigned without an active Labeler Code. The Labeler Code is the foundation segment of every NDC and must be obtained first.
Does the Labeler Code mean my drug is FDA-approved?
No. A Labeler Code is purely an identification number. It is explicitly not FDA approval, clearance, or endorsement of the drug. Claiming otherwise is misbranding under 21 CFR 207.77.
What if my company name or address changes after I get a Labeler Code?
Changes must be reported to the FDA through an SPL update so that the Labeler Code record remains accurate. The Labeler Code itself stays the same — only the underlying company information is updated.
How much does Drug Labeler Code registration cost through FDA Registration Assistance?
FDA Registration Assistance charges $349 USD per company for the complete Labeler Code registration service, including SPL preparation, CDER Direct submission, FDA confirmation tracking, and post-assignment documentation.
What does the $349 fee cover, and how does it stack with Drug Establishment Registration and NDC Code services?
The $349 covers the complete Drug Labeler Code application — SPL preparation, CDER Direct submission, FDA tracking, and delivery of the assigned Labeler Code. Most drug companies need three sequential services: Drug Establishment Registration at $449/year (under 21 CFR Part 207, with U.S. Agent included), the Drug Labeler Code at $349 (under 21 CFR 207.33), and NDC Code / Product Code registration at $199 per product. Together a typical first-year compliance package is $449 + $349 + $199 = $997 for one product. The Labeler Code remains valid year-over-year, and only the Drug Establishment Registration renews annually.
Can a friend or unrelated party apply for the Drug Labeler Code on behalf of my company?
Technically yes, but the Labeler Code is bound to the legal entity named in the SPL — not to whoever files it. If a friend submits the application using their own DUNS, company name, or address, the Labeler Code will legally belong to them, not to your business. This creates serious problems if you later need to assign NDCs, respond to FDA, or transfer ownership. A professional service files in your legal entity's name with your DUNS, ensuring the Labeler Code is correctly owned.
What happens if I do not respond to FDA requests for additional information during Labeler Code review?
The SPL submission will be rejected or placed on hold and no Labeler Code will be assigned. The FDA typically issues clarification requests within the 10-business-day review window when DUNS records, addresses, or company-relationship fields do not match. Failure to respond means you must resubmit from scratch, delaying NDC assignment and product launch. FDA Registration Assistance monitors the submission and responds to any FDA queries on your behalf as part of the $349 service.
How do I change or transfer the Labeler Code on an existing FDA record?
Labeler Codes themselves are not transferable between companies — they are tied to a specific legal entity. However, you can update the company name, address, DUNS, or contact person on the existing record by submitting an SPL change request through CDER Direct. If your company is acquired or undergoes a legal-entity change, FDA generally expects the new entity to obtain its own Labeler Code and re-list affected products under new NDCs. FDA Registration Assistance handles both update filings and successor-entity applications.
Do I need a Drug Labeler Code to sell OTC drugs or sunscreen on Amazon?
Yes. Amazon's drug and OTC categories — including sunscreens, hand sanitizers, acne products, pain relievers, and topical antiseptics — require sellers to provide a valid FDA Labeler Code and corresponding NDC before listings are approved. Without an active Labeler Code, Amazon will reject the listing or delist existing products during category audits.
Does a Drug Labeler Code mean the FDA has approved my drug?
No. A Labeler Code is a company identifier only — it is not approval, endorsement, or evaluation of the drug product itself. 21 CFR 207.77 explicitly prohibits representing that a Labeler Code or NDC implies FDA approval. Marketing copy claiming "FDA-approved" based on a Labeler Code is misbranding under §502(a) of the FD&C Act.
Do private label brand owners and contract distributors need their own Labeler Code?
Yes. Any firm whose name appears on the drug product label — even if a contract manufacturer makes the product — must have its own Labeler Code under 21 CFR 207.33. Private label brand owners cannot use their contract manufacturer's Labeler Code; each labeler-of-record needs an independent code in the FDA's records.
Are OTC monograph drugs required to have a Labeler Code?
Yes. OTC monograph drugs — including sunscreens, hand sanitizers, antiperspirants, dandruff shampoos, acne treatments, and topical pain relievers — must have a Labeler Code and NDC, even though they do not require an individual NDA approval. The Labeler Code requirement applies equally to Rx and OTC drug products.
Can a Drug Labeler Code use a P.O. Box or virtual office as its registered address?
No. The FDA requires the physical street address of the company's actual place of business — not a P.O. Box, virtual office, or mail-forwarding service. The address must match the company's DUNS record. Mismatched or non-physical addresses are the most common cause of Labeler Code rejection during SPL review.
How do I verify that a Drug Labeler Code is real and active with the FDA?
Use the FDA's National Drug Code Directory on FDA.gov to search by labeler name or by the Labeler Code segment of an NDC. If the code does not return any listed products or labeler record, it is either inactive, never assigned, or fraudulent. FDA Registration Assistance provides directory-verifiable confirmation for every Labeler Code it files.
Do compounding pharmacies and 503B outsourcing facilities need a Labeler Code?
503B outsourcing facilities must have a Labeler Code and submit drug listings under 21 CFR Part 207. Traditional 503A compounding pharmacies that compound only on patient-specific prescriptions are generally exempt from drug listing — and therefore from Labeler Code requirements — unless their operations exceed Section 503A limits.
What is the difference between a 5-digit and 6-digit Labeler Code?
The original Labeler Code segment was 4 or 5 digits, but the FDA exhausted that range and now assigns 6-digit Labeler Codes to new applicants. Both are valid — a 5-digit code paired with a 4-digit product code and 2-digit package code yields the same 11-digit billing NDC as a 6-digit code paired with the appropriate product/package segments.
Do API (active pharmaceutical ingredient) manufacturers need a Labeler Code?
Only if the API is commercially distributed in the U.S. as a finished labeled product under the company's own name. Bulk API manufacturers that supply other finished-dose drug makers typically do not need a Labeler Code themselves — but they must still register the establishment under 21 CFR Part 207. The Labeler Code requirement attaches to the firm whose name is on the marketed drug product label.
Can I use my Drug Establishment Registration number (FEI) instead of a Labeler Code?
No. The FEI (FDA Establishment Identifier) identifies the physical facility — the Labeler Code identifies the labeler-of-record company on the product. They are different numbers serving different purposes, and one cannot substitute for the other. Most drug companies need both: an FEI for the facility and a Labeler Code for the firm whose name appears on the product label.
Get Your FDA Drug Labeler Code Today
Submit your company details and FDA Registration Assistance will prepare your Labeler Code request in SPL format, verify your DUNS information, and submit directly to the FDA — getting your Labeler Code assigned in approximately 10 business days.
Thank You for Reaching Out!
We've received your message and will get back to you within 24 hours. If you need immediate assistance, please call us directly.