FDA Drug Label & Ingredient
Review Services

The review checks the labeling requirements that apply to the specific product and can include regulatory pathway, Drug Facts or prescription labeling format, active and inactive ingredients, uses, warnings, directions, claims, principal display panel information, required statements, and consistency with the submitted formulation and FDA records.

Our standard professional fee is $249 per drug product label review. The standard scope includes written findings and one post-revision verification of the corrected label.

Our typical service target is 3–7 business days after complete artwork, formulation, and product information are received. Complex products, incomplete information, or questions about marketing status can require additional time.

FDA's Drug Facts requirements apply broadly to OTC drug products, but the specific labeling analysis should account for the product, package, and any applicable exceptions or special provisions. We review the actual product rather than assuming one template applies in every situation.

The standardized OTC Drug Facts content and format requirements are primarily in 21 CFR 201.66.

Drug Facts generally includes active ingredient and purpose, uses, warnings, directions, other information, inactive ingredients, and other required information arranged under the applicable FDA format rules.

An OTC monograph establishes conditions such as active ingredients, uses, doses, routes, labeling, and sometimes testing under which a category of nonprescription drugs can be marketed without an approved drug application when all applicable requirements are met.

Yes. Section 505G of the FD&C Act modernized the OTC monograph system and FDA now uses an administrative-order process to establish or modify many monograph conditions.

The review can flag whether the submitted formulation, claims, strengths, directions, or other information appear inconsistent with the intended monograph pathway. A complex eligibility or formulation analysis can require additional regulatory work beyond a basic artwork review.

No. OTC monograph drugs that meet section 505G, the applicable monograph conditions, and other requirements can generally be marketed without an approved NDA for that individual product. That does not mean FDA pre-approved the specific label.

Yes. Prescription labeling can be reviewed against the requirements that apply to the specific product, including 21 CFR 201.56 and 201.57 for PLR-format prescribing information where applicable. Some older-format labeling can involve 21 CFR 201.80.

Not necessarily. FDA maintains PLR-format requirements and also recognizes older-format labeling under 21 CFR 201.80 for certain products. The applicable format depends on the product and regulatory history.

No. For an approved drug, labeling changes are governed by the approved application and applicable supplement/reporting requirements. A consultant review does not replace the sponsor's FDA submission or approval obligations.

Yes. We review the active ingredient name, strength or concentration, purpose, dosage form, route, and consistency with the intended regulatory pathway and the materials provided.

Yes. Inactive ingredient declaration and presentation are reviewed based on the applicable drug-labeling requirements and the complete formulation supplied by the client.

Under 21 CFR 201.66, inactive ingredients are generally listed in alphabetical order in the Drug Facts panel, subject to the applicable requirements and product-specific circumstances.

Yes. Warnings and directions are core review areas because the required language can depend on the product category, active ingredient, dosage, intended use, monograph/order, or approved labeling.

Yes, when the claims are supplied as part of the review. We flag claims that appear inconsistent with the applicable monograph, approved labeling, intended use, or general false-or-misleading labeling standards.

No. A professional review reduces avoidable labeling errors but cannot guarantee an FDA inspection, import, enforcement, or marketplace outcome. FDA can evaluate the complete product, manufacturing, marketing status, records, and labeling.

No. A consultant label review is not FDA approval, clearance, certification, or endorsement.

No. FDA states that an NDC or drug listing does not by itself mean the drug is approved.

No. FDA's listing databases contain information submitted by companies, and listing is separate from a regulatory determination that the product or label complies with all applicable requirements.

No. Dietary supplements are labeled under the food/supplement framework and generally use a Supplement Facts panel rather than a Drug Facts panel.

A cosmetic-only product does not use the OTC Drug Facts framework. If claims or ingredients cause the product to be a drug as well as a cosmetic, the applicable drug requirements must also be evaluated.

Sunscreen marketed as an OTC drug must satisfy the applicable OTC drug requirements, including the relevant monograph/order conditions, Drug Facts labeling, and other applicable requirements. The precise formulation and claims should be reviewed.

Hand sanitizers can be drug products depending on their intended use and claims. The applicable legal marketing status and labeling should be reviewed rather than assuming that any formula can be marketed by simply adding a Drug Facts panel.

No. FDA states that there are no FDA-approved products labeled as homeopathic. Homeopathic products remain subject to federal drug requirements, and FDA applies a risk-based enforcement approach to unapproved homeopathic drugs.

No. Homeopathic status is not an OTC monograph approval pathway. FDA states that homeopathic products are subject to the same statutory requirements related to approval, adulteration, and misbranding as other drugs.

Drug expiration dating is governed by CGMP and product-specific requirements, and FDA recognizes limited exceptions. For example, 21 CFR 211.137 contains exceptions for certain OTC products and homeopathic drugs. We avoid treating expiration-date requirements as identical for every product.

Drug traceability and packaging controls are governed by applicable CGMP and labeling requirements. The correct presentation depends on the product and packaging configuration rather than one universal artwork rule.

FDA's drug labeling language rules generally require required information in English, but 21 CFR 201.15 includes circumstances involving U.S. territories where another language is predominant and also governs multilingual labeling. Puerto Rico and other territory-specific situations should be reviewed before assuming English is always the only permissible presentation.

When labeling contains a foreign-language representation, 21 CFR 201.15 can require the required label information to appear in the foreign language as well. The exact application should be checked against the product and distribution circumstances.

The answer depends on the packaging configuration and applicable OTC labeling rules, including small-package and other provisions. We review the actual carton/container set rather than applying a blanket 'both in all cases' rule.

We can flag those claims as part of a label review, but country-of-origin and U.S.-origin claims can involve CBP and FTC rules in addition to FDA drug-labeling requirements. Specialized origin analysis may be outside the basic drug-label review scope.

We review the submitted ingredient list for labeling and obvious regulatory issues within scope. A full color-additive, excipient safety, compendial, or formulation-permissibility assessment may require separate research.

The standard $249 service is a regulatory review, not a graphic-design or artwork-redesign service. We provide written corrections that your designer can implement.

Yes. One standard post-revision verification is included in the $249 review scope. Additional revision rounds or major product changes can require a new or expanded review.

Drug listing information must be kept current under Part 207. Whether a particular change requires a listing update depends on the change and the applicable listing requirements. A label review and an SPL listing update are separate services.

Yes. We can review labeling intended for the U.S. market for foreign manufacturers, repackers, relabelers, distributors, and brand owners. Foreign drug import compliance also involves separate establishment, listing, marketing-status, cGMP, and import requirements.

Send the full label artwork, complete active/inactive ingredient list with strengths, dosage form, route, intended use, product category, OTC monograph or NDA/ANDA information if known, current NDC/listing information if available, and any claims you want reviewed.