The OTC Review is the name of the process established in 1972 by the U.S. Food and Drug Administration (FDA) to review the safety and efficacy of OTC ingredients, doses, formulations, and labeling used in medicines available to consumers without a prescription.

The OTC Review process is not yet complete. The current status of an OTC medicine can be viewed by visiting the rulemaking history for OTC drug products section of FDA’s Center for Drug Evaluation and Research’s web site. Those ingredients and indications which are not covered by final monographs are in tentative final monographs.

Related links:

• Listing of OTC active ingredients (alphabetical)
• Listing of OTC active ingredients (by monograph category)
• Development and Regulation of OTC (Nonprescription) Drug Products
• FAQs About the OTC Review