FDA OTC Drug Monograph

About FDA OTC Drug Monographs

OTC monographs define the safety, effectiveness, and labeling of OTC active ingredients. If a drug is in an OTC final monograph, companies can manufacture and market that OTC product without FDA pre-approval.

Each OTC drug monograph is a kind of “recipe book” covering acceptable ingredients, doses, formulations, labeling, and in some cases, testing parameters. OTC drug monographs are continually updated to add additional ingredients and labeling. Products conforming to a monograph may be marketed without FDA pre-approval.

Think of an OTC monograph as a rulebook for a specific category of OTC drugs. It establishes the guidelines under which a drug can be considered generally recognized as safe and effective (GRASE) for its intended use, without needing a full drug application approval process (NDA or ANDA).

Common examples of OTC Monograph drugs include: antiseptic hand sanitizers, antiseptic hand washes, sunscreen, acne cream, pain relief cream (menthol), anti-dandruff shampoo, antacids, and many more.

While pre-approval is not required for monograph drugs, establishment registration, drug listing, and NDC labeler code are still required. LMG assists foreign and domestic OTC monograph drug manufacturers with all registration and compliance requirements.

• Drug establishment registration required — even for OTC monograph drugs
• NDC Labeler Code required for all drug product listing
• Drug listing required and updated every June and December
• Annual registration renewal required between October 1 and December 31
• Drug label must comply with OTC monograph labeling requirements