Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Historical Status of OTC Rulemakings

Historical Status of OTC Rulemakings Home
          Drugs
          Development & Approval Process | Drugs
          How Drugs are Developed and Approved
          Over-the-Counter OTC | Nonprescription Drugs
          Historical Status of OTC Rulemakings
          Rulemaking History of General Labeling Requirements for OTC Drug ProductsHistorical Status of OTC Rulemakings Rulemaking History of General Labeling Requirements for OTC Drug Products
  
  	
    Share
    Post
    Linkedin

    Email
    Print**OTC Drug Product Labeling Regulations** (21 CFR part 201 subpart C):*Labeling Requirements for Over-the-Counter Drugs*

FDA Archive-It webpage:
Rulemaking History of General Labeling Requirements for OTC Drug ProductsSearch for Federal Register documents:

GPO Federal Register Database (1994 to present)
	HeinOnline provides online access to Federal Registers from 1936-forward

OTC Drug Product Labeling found on this page:

Calcium, Magnesium, and Potassium
	Exclusivity Policy
	Phenylpropanolamine (PPA)
	Pregnancy Warning
	Sodium Labeling
	Drug Facts Format
	Statement of Identity
	Adverse Event Reporting
	Convenience-Size
	Label Comprehension Studies
	Dosage Delivery Devices**Labeling of Drug Products: Calcium, Magnesium and Potassium**

Proposed Rule
			Date
			*FR* CitationProposed Rule: Requires labeling for oral OTC drug products
			4/22/1996
			61FR17807Extension of Comment Period
			7/22/1996
			61FR38047Correction
			8/19/1996
			61FR42826Final Rule
			Date
			*FR* CitationFinal Rule
			3/24/2004
			69FR13725

**Labeling of Drug Products: Exclusivity Policy**

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationNotice: Public hearing
			7/2/1982
			47FR29002Proposed Rule
			Date
			*FR* CitationProposed Rule: Allows alternative language for indications (exclusivity policy)
			4/22/1985
			50FR15810Proposed Rule: Miscellaneous additional interchangeable terms
			4/5/1993
			58FR17553Proposed Rule: Exclusivity policy applies to approved NDAs
			11/9/1993
			58FR59622Proposed Rule: Additional interchangeable terms "do not mix drugs"; requests comment on revising "do not use" warning
			8/3/1994
			59FR39499Proposed Rule: Additional interchangeable terms "do not use with"
			10/4/1995
			60FR52058Proposed Rule: Additional interchangeable terms "unless a doctor tells you"
			3/4/1996
			61FR8450Final Rule
			Date
			*FR* CitationFinal Rule: Allows alternative language for indications (exclusivity policy)
			5/1/1986
			51FR16258Correction
			5/21/1986
			51FR18580Correction
			3/13/1987
			52FR7830Final Rule: Miscellaneous additional interchangeable terms
			1/28/1994
			59FR3998

**Labeling of Drug Products: Phenylpropanolamine (PPA)**

Proposed Rules
			Date
			*FR* CitationProposed Rule: Requires warning
			2/14/1996
			61FR5912Notice of Withdrawal
			12/12/2008
			73FR75625

**Labeling of Drug Products: Pregnancy Warning**

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationProposed Rule
			Date
			*FR* CitationProposed Rule: Requires warning for systemically absorbed OTC drugs
			9/7/1982
			47FR39470Correction
			9/21/1982
			47FR41580Reopening of Administrative Record: Requests comment on requiring warning for all OTC drugs
			11/30/1983
			48FR54077Proposed Rule: Specific warning for oral and rectal aspirin- containing OTC products
			11/16/1988
			53FR46204Final Rule
			Date
			*FR* CitationFinal Rule
			12/3/1982
			47FR54750Notice: Exemptions to 12/3/1982 final rule
			8/31/1983
			48FR39452Final Rule: Specific warning for oral and rectal aspirin-containing OTC products
			7/5/1990
			55FR27776

**Labeling of Drug Products: Sodium Labeling**

Proposed Rule
			Date
			*FR* CitationProposed Rule: Requires labeling for oral OTC drugs
			4/25/1991
			56FR19222Correction
			5/22/1991
			56FR23619Extension of Comment Period
			6/12/1991
			56FR26946Proposed Rule: Requires labeling for rectal OTC drugs
			3/24/2004
			69FR13765Final Rule
			Date
			*FR* CitationFinal Rule: Requires labeling for oral OTC drugs
			4/22/1995
			61FR17798Extension of Comment Period
			7/22/1996
			61FR38046Correction
			3/21/1997
			62FR13733Partial Delay of Effective Date: Delays to coincide with calcium, magnesium, potassium final rule
			4/24/1997
			62FR19923Technical Amendment: Termination of delay of effective date
			3/24/2004
			69FR13717Final Rule Requires labeling for rectal OTC drugs
			11/29/2004
			69FR69278

**Labeling of Drug Products: Drug Facts Format**

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationNotice: Request for comment on print size requirements
			3/6/1991
			56FR9363Extension of Comment Period
			4/9/1991
			56FR14384Notice: Hearing on OTC labeling
			8/16/1995
			60FR42578Proposed Rule
			Date
			*FR* CitationProposed Rule
			2/27/1997
			62FR9024Extension of Comment Period
			6/19/1997
			62FR33379Notice: Availability of Study Data and Reopening of Comment Period
			12/30/1997
			62FR67770Notice: Availability of Study Data and Reopening of Comment Period
			2/13/1998
			63FR7331Final Rule
			Date
			*FR* CitationFinal Rule
			3/17/1999
			64FR13254Correction
			4/15/1999
			64FR18571Technical Amendment: Clarifies regulations
			1/3/2000
			65FR7Partial Extension of Compliance Dates
			6/20/2000
			65FR38191Partial Delay of Compliance Dates: Convenience size OTC drugs
			4/5/2002
			67FR16304Delay of Implementation: OTC sunscreen drugs
			9/3/2004
			69FR53801Notice: Draft Guidance on Drug Facts
			12/1/1999
			64FR67291Notice: Draft Guidance on submitting exemptions to Drug Facts
			12/19/2000
			65FR79371Notice: Draft Guidance on Drug Facts
			12/9/2004
			69FR71420Notice: Draft Guidance on Drug Facts; Q and A
			 Draft Guidance
			1/13/2005
			70FR2415Notice: Guidance on Drug Facts; Q and A
			 Guidance
			1/5/2009
			74FR303PRA 60-Day Notice: Extension of Collection Activity
			1/4/2005
			70FR362PRA 30-Day Notice: Extension of Collection Activity
			3/29/2005
			70FR15864PRA 60-day Notice: Reinstatement of Collection Activity
			6/3/2010
			75FR31448PRA 30-day Notice: Reinstatement of Collection Activity
			8/13/2010
			75FR49495OMB Approval Notice: Reinstatement of Collection Activity
			2/16/2011
			76FR9022

**Labeling of Drug Products: Statement of Identity**

Proposed Rule
			Date
			*FR* CitationProposed Rule: Requires for single actives and combinations as stated in OTC drug monographs
			4/17/1986
			51FR13023Extension of Comment Period
			6/3/1986
			51FR19853

**Labeling of Drug Products: Adverse Event Reporting**

Proposed Rule
			Date
			*FR* CitationProposed Rule: Requires toll-free number for reporting adverse events
			4/22/2004
			69FR21778Final Rule
			Date
			*FR* CitationInterim Final Rule: Requires toll-free number for reporting adverse events
			1/3/2008
			73FR402Final Rule: Requires toll-free number for reporting adverse events
			10/28/2008
			73FR63886Notice: Draft Guidance on Labeling: Q and A
			12/11/2008
			73FR75436Notice: Guidance on Labeling: Q and A
			Guidance
			9/1/2009
			74FR45222

**Labeling of Drug Products: Convenience-Size**

Proposed Rule
			Date
			*FR* CitationProposed Rule: Defines "convenience-size" & allows alternative labeling
			12/12/2006
			71FR74474

**Labeling of Drug Products: Label Comprehension Studies**

Proposed Rule
			Date
			*FR* CitationNotice: Label Comprehension Studies
			Draft Guidance
			5/1/2009
			74FR20322Notice of Availability: Final Guidance
			8/3/2010
			75FR45641

**Labeling of Drug Products: Dosage Delivery Devices**

Proposed Rule
			Date
			*FR* CitationNotice: Draft Guidance on Dosage Delivery Devices for Liquid Products
			Draft Guidance
			11/5/2009
			74FR57319

                                                                                  Content current as of:
      03/01/2022Historical Status of OTC Rulemakings
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop