Over-the-Counter (OTC) Related Federal Register Notices, Ingredient References, and other Regulatory Information
OTC-Related Federal Register Publications
- Rulemaking History for OTC Drug Products. Index of Full-text Federal Register publications organized by OTC drug product category.
- Annual Comprehensive List of Guidance Documents at the Food and Drug Administration (PDF - 740KB)
- Rulemaking History for OTC Sunscreen Drug Products
Index of Human OTC Drug Federal Register Publications
- 2000 to 2014 (PDF 113KB) (updated 6/2014)
- 1990 to 2003
- 1980-1989
- 1972-1981
Status of OTC Rulemakings
- Unified Agenda (GPOAccess) Rulemakings under review/development.
- Drug Facts Labeling Information
OTC Drug Product and Ingredient References
- Listing of OTC Active Ingredients (updated 4/9/2010)
- Approved Drug Products (Orange Book)
- National Drug Code (NDC) Directory
- New & Generic Drug Approval Packages (from Drugs@FDA)
- Inactive Ingredient Search for Approved Drug Products
- Rx-to-OTC Switch List
Other Regulatory Information
- How FDA Regulates OTC Drugs
- Frequently Asked Questions on the Regulatory Process of OTC Drugs
- Guidelines for Effectiveness Testing of OTC Antiperspirant Drug Products (PDF - 14KB)
- Effectiveness Testing for OTC Anticaries Drug Products (PDF - 531KB)
- Nonprescription Drugs Advisory Committee (NDAC) Meetings
- How to Comment on Proposed Regulations and Submit Petitions
- Laws Enforced by FDA
- Regulatory and Scientific Guidances
- Import Regulations and Procedures
- Drug Registration and Listing Requirements
- Small Business Assistance
- Regulations.gov. This U.S. Government web site makes it easier for you to participate in Federal rulemaking - an essential part of the American democratic process.