Enforcement Actions

• OTC Warning Letters
• All FDA Warning Letters

OTC Information for Consumers

also see Resources for You

• Antimalarials/Leg Cramps/Quinine
• Cough/Cold
• Internal Analgesics
• Nicotine Containing Products
• Pediculicides
• Sunscreens
• OTC Consumer alerts

OTC Information for Industry

also see Resources for You

• Code of Federal Regulations Title 21
• 21 CFR Part 300
• OTC Drug Monograph Rulemakings
• OTC Active Ingredients - Alphabetical Listing (PDF - 4.6MB)
• OTC Active Ingredients - By Monograph (PDF - 4.2MB)
• OTC Drug Guidances
• New Drug Application (NDA)
• Drugs@FDA
  Look up OTC and Rx NDA Drug Products
• Federal Food, Drug, and Cosmetic Act FD&C Act Main Page