OTC Drug Monograph

OTC drugs are defined as "drugs that are safe and effective for use by the general public without seeking treatment by a health professional."

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

New FDA OTC Monograph Drug Facility Fees 2024

Examples of Drugs in FDA Monograph

These are not complete list of products in FDA OTC drug monograph. The status of drug in OTC monograph may change please contact FDA for updated information.

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