About FDA
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Over-the-Counter (OTC) Related Federal Register Notices, Ingredient References, and other Regulatory Information
OTC-Related Federal Register Publications Spotlight
- Rulemaking History for OTC Drug Products. Index of Full-text Federal Register publications organized by OTC drug product category.
- FDA Regulations Open for Comment
- Annual Comprehensive List of Guidance Documents at the Food and Drug Administration (PDF - 740KB)
- Summary of Sunscreen Rulemakings (PDF - 56KB)
Index of Human OTC Drug Federal Register Publications
- 2000 to 2011 (PDF 113KB) (updated 3/9/11)
- 1990 to 2003 (PDF - 415KB)
- 1980-1989 (PDF - 37KB)
- 1972-1981 (PDF - 23KB)
Status of OTC Rulemakings
- Unified Agenda
(GPOAccess) Rulemakings under review/development. - Drug Facts Labeling Information
- Sample Drug Facts Labels (PDF - 1MB)
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
- Clarification of Recent FDA Initiatives Affecting OTC Drugs
- 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
- Chronological List of All NDAC Meetings (1992 to Present)
- 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.
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