FDA OTC Drug Establishment Registration and OTC Drug Listing

FDA OTC Drugs & OTC Monographs

Over-the-counter (OTC) drug products play an increasingly important role in America’s health care system. OTC drugs are defined as drugs that are safe and effective for use by the individuals without requiring a prescription by a physician. Currently there are over 300,000 marketed OTC drugs in the U.S. The FDA reviews the active ingredients and labeling of over 80 therapeutic categories of OTC drugs instead of individual drug products.

For each therapeutic class, an OTC drug monograph is developed and published by FDA. OTC drug monographs act as “standardized recipe book” covering the acceptable ingredients, doses, formulations, and labeling requirements. Once a final monograph is followed and implemented, OTC drug manufacturing companies can make and market an OTC drug product without a need for FDA pre-approval. These monographs outline the safety, effectiveness, and the FDA labeling requirements for OTC drugs.

Those OTC products that do not conform to an already established FDA monograph must be reviewed by the FDA New Drug Application (NDA) process. Cosmetic products that have therapeutic claims must also follow the FDA requirements of OTC drug monographs. Toothpastes products that use fluoride as an active ingredient and some antidandruff shampoos are good examples.

OTC Drug Establishment Registration and OTC Drug Listing

Both U.S. based and non-US drug establishments that are involved in manufacturing, relabeling, repacking, distributing or importing of the OTC drugs for commercial use in the U.S. are required to register and list their products. FDA drug establishment registration involves submitting the drug establishment information in a Structured Product Labeling (SPL) format. SPL is a coded data format that is adopted by FDA for FDA drug establishment registration and drug listing. OTC drug listing also involves submitting the drug product label as well as drug information in SPL format.

A complete list of who must register and list can be accessed here.

OTC Drug Labeling Requirements

FDA neither reviews nor does pre-approve the label of the OTC drug products. Instead, it is the responsibility of the OTC drug manufacturer or distributor to comply with FDA OTC drug labeling requirements published by the FDA. The OTC drug label must comply with a certain universal format and content requirements for drug fact panel and principal display panel of the drug package, among other things.

FDA Registration Certificate

After your registration is complete, the registered drug establishment will be assigned with an FDA registration number by FDA. In practice, FDA does not issue any registration certificate however, as a third-party agent, FDA Listing Inc. will provide you with a certificate of FDA registration that can be used as FDA registration confirmation before U.S. custom, importers, distributers and other commercial outlets.

If you are OTC drug manufacturer and need assistance with identifying OTC monographs or OTC drug establishment registration and listing of OTC drug product, FDA Listing Inc. can assist you. FDA Listing Inc. also reviews your OTC drug label to insure FDA compliance. Feel free to contact us with any OTC drug related questions.

137 thoughts on “FDA OTC Drug Establishment Registration and OTC Drug Listing”

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    This article does a good job explaining OTC drug registration and FDA requirements in a clear way. It’s especially useful for manufacturers needing guidance on labeling, monographs, and regulatory compliance before entering the U.S. healthcare market.

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    The OTC drug framework works on pre-approved standards called monographs. These standards guide how medicines are made and labeled. It ensures consistency across products in the same category, so people receive reliable treatment options while companies follow clear and established requirements for production and marketing.

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