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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.

Examples of Drugs in FDA Monograph

Services and Fees

FDA Registration,
US Agent, Labeler code

USD 649 (Annually)

Drug listing

USD 399 / Drug

Label Review

USD 649 / Drug