OTC Monograph

A regulatory framework established by the FDA that defines the conditions under which certain over-the-counter drug products are generally recognized as safe and effective (GRASE) without individual product approval. Specifies acceptable active ingredients, doses, formulations, and labeling for each therapeutic category. Reformed under the CARES Act of 2020 to allow administrative order-based updates.

Exemplos

• Acetaminophen 325-1000 mg for pain relief
• Diphenhydramine 25-50 mg as sleep aid
• Benzoyl peroxide 2.5-10% for acne