Over-the-Counter (OTC) Drugs Branch
Spotlight
- Gluten in Drug Products and Associated Labeling Recommendations; Draft Guidance for Industry
- Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin Reactions
- Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled With Cardiovascular Related Imagery
Enforcement Actions
OTC Information for Consumers
- Antimalarials/Leg Cramps/Quinine
- Cough/Cold
- Internal Analgesics
- Nicotine Containing Products
- Pediculicides
- Sunscreens
- OTC Consumer alerts
- Drug Safety Communications
- FDA warns consumers about potential risks of using eye drops packaged in bottles with loose safety seals
- Division of Drug Information (DDI)
- FDA Medwatch
OTC Information for Industry
- Over-the-Counter (OTC) Related Federal Register Notices, Ingredient References, and other Regulatory Information
- Code of Federal Regulations Title 21
- 21 CFR Part 300
- OTC Drug Monograph Rulemakings
- OTC Active Ingredients - Alphabetical Listing
- OTC Active Ingredients - By Monograph
- Drugs@FDA
- Federal Food, Drug, and Cosmetic Act
- Regulation of Nonprescription Products
- CDER Small Business Assistance with Over-the-Counter (OTC) Drugs
- Drug Registration and Listing
- Division of Non-Prescription Drugs and Health Fraud