Over-the-counter (OTC) drugs — products like pain relievers, antacids, cough medicines, topical antiseptics, sunscreens, and anti-dandruff shampoos — are sold without a prescription but are fully regulated as drugs under the Federal Food, Drug, and Cosmetic Act. For foreign manufacturers, this means that OTC drugs cannot be exported to the United States without completing a set of FDA filings that are entirely separate from food or cosmetics registration. The OTC drug regulatory pathway involves drug establishment registration under 21 CFR Part 207, obtaining a National Drug Code (NDC) Labeler Code, listing each drug product with the FDA, and ensuring the product complies with the applicable OTC drug monograph or holds an approved New Drug Application (NDA). These requirements apply to every foreign manufacturer, regardless of whether the product is sold as an OTC drug in the manufacturer's home country.
The OTC monograph system
Most OTC drugs are marketed under the OTC drug monograph system, which specifies the active ingredients, doses, indications, and labeling requirements that a product must meet in order to be marketed without an individual NDA. The monographs are organized by therapeutic category — analgesics (21 CFR Part 343), antacids (21 CFR Part 331), sunscreens (21 CFR Part 352), anti-dandruff products (21 CFR Part 358), anticaries (fluoride) products (21 CFR Part 355), and many others. A product that conforms to all conditions of an applicable monograph can be marketed as an OTC drug without prior FDA approval — but it must still be registered and listed. The CARES Act of 2020 reformed the monograph system, replacing the prior notice-and-comment rulemaking process with an administrative order process that allows the FDA to update monographs more quickly.
Drug establishment registration under 21 CFR Part 207
Every foreign establishment that manufactures, repacks, relabels, or salvages OTC drug products for the US market must register with the FDA annually. The registration is submitted through FDA's electronic Drug Registration and Listing System (eDRLS) using the Structured Product Labeling (SPL) format. The registration period runs from October 1 to December 31 each year, and establishments that fail to register or renew are considered unregistered — their products are subject to import detention. Foreign establishments must designate a US Agent as part of the registration, and the US Agent must be available during US business hours to receive FDA communications.
NDC Labeler Code and drug listing
Before an OTC drug can be marketed in the United States, the responsible person must obtain an NDC Labeler Code from the FDA. The Labeler Code is the first segment of the National Drug Code — a unique 10-digit, three-segment identifier (Labeler Code - Product Code - Package Code) that identifies every drug product in commercial distribution. The Labeler Code is assigned to the company whose name appears on the drug label, which may be the manufacturer, the distributor, or the repacker depending on the labeling arrangement. Once the Labeler Code is assigned, each individual drug product must be listed with the FDA through eDRLS, including the product name, active ingredients, dosage form, route of administration, and the Drug Facts panel content.
Drug Facts panel requirements
Every OTC drug sold in the United States must carry a Drug Facts panel on its label, formatted in accordance with 21 CFR 201.66. The Drug Facts panel must include the active ingredient(s) and their purpose, the product's uses (indications), warnings (including specific warnings required by the applicable monograph, such as allergy alerts, pregnancy warnings, and age-specific cautions), directions for use, other information (such as storage conditions), and inactive ingredients listed in alphabetical order. The Drug Facts format is distinct from the Nutrition Facts format used for food products and from the Supplement Facts format used for dietary supplements — foreign manufacturers who have experience with food or supplement labeling must understand that drug labeling follows its own prescriptive format.
Annual establishment fees
Drug establishment registration carries annual user fees under the Generic Drug User Fee Amendments (GDUFA) and the Prescription Drug User Fee Act (PDUFA). For fiscal year 2026, the annual establishment fee for domestic and foreign drug establishments is published by the FDA each year in the Federal Register. These fees apply to establishments that manufacture finished dosage form drugs, API manufacturers, and certain other types of drug establishments. The fees are not insignificant — they typically run into thousands of dollars per year — and failure to pay the required fee results in the establishment's registration being placed on hold and its products being subject to import refusal. Foreign OTC drug manufacturers must budget for these annual fees as an ongoing cost of US market access.
How FDABridge handles OTC drug registration
FDABridge manages drug establishment registration, NDC Labeler Code acquisition, and drug product listing for foreign OTC drug manufacturers. Our team handles the electronic filings through FDA's eDRLS system in SPL format, ensures your Drug Facts labeling meets the prescriptive requirements of 21 CFR 201.66, and provides US Agent services as part of the registration package. Visit fdabridge.com/drug to see our drug registration services or fdabridge.com/apply/drug to begin your filing.
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