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
| Acne Anorectal Antacid Antibiotic Anticaries Antidiarrheal Antiemetic Antiflatulent Antifungal Antimicrobial Antiperspirant Antiseptic Corn and Callus Remover Cough and Cold Dandruff | External Analgesic Hand-Sanitizer Internal Analgesic Laxative Nighttime sleep aid Ophthalmic Oral Health Care Otic Overindulgence in Alcohol/Food Pediculicide Skin Protectant Stimulant Sunscreen wart remover |
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