-
About FDA
-
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.
- FDA Regulations Open for Comment
- Annual Comprehensive List of Guidance Documents at the Food and Drug Administration [TXT] [PDF] (Issued 1/5/2005)
- Summary of Sunscreen Rulemakings [PDF]
Index of Significant OTC Drug Federal Register Publications
- 2000 to 2008 [PDF] (Updated 8/14/2008)
- 1990 to 2003 [PDF]
- 1980-1989 [PDF]
- 1972-1981 [PDF]
Status of OTC Rulemakings
- Unified Agenda [PDF] Rulemakings under review/development.
- Drug Facts Labeling Information
- Sample Drug Facts Labels [PDF]
OTC Drug Product and Ingredient References
- Listing of OTC Active Ingredients
- 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]
- 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.
-
-