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  for OTC Food and Drink Overindulgence Drug ProductsHistorical Status of OTC Rulemakings Rulemaking History  for OTC Food and Drink Overindulgence Drug Products
  
  	
    Share
    Post
    Linkedin

    Email
    Print**Pending Final Monograph**(21 CFR part 357 subpart J)**:*****Miscellaneous Internal Drug Products for Over-the-Counter Human Use: Orally Administered Drug Products for Relief of Symptoms Associated with Overindulgence in Food and Drink for Over-the-Counter Human Use*OTC Food and Drink overindulgence Drug Products found on this page:Original Active Ingredients and LabelingInternal AnalgesicsAntacidsBismuth SubsalicylateStimulants**Food and Drink Overindulgence Drug Products: Original Active Ingredients and Labeling**Advance Notice Of Proposed RulemakingDate*FR* CitationAdvance Notice of Proposed Rulemaking10/1/198247FR43540Correction12/10/198247FR55497Correction12/21/198247FR56871Extension of Comment Period1/4/198348FR270Notice: Classifies "prevention of inebriation" claim as nonmonograph7/19/198348FR32872Proposed RuleDate*FR* CitationTentative Final Monograph12/24/199156FR66742Correction3/4/199257FR7847**Food and Drink Overindulgence Drug Products: Internal Analgesics**Proposed RuleDate*FR* CitationProposed Rule: Amends 21 CFR part 343 to allow stimulant and internal analgesic combinations12/24/199156FR66762**Food and Drink Overindulgence Drug Products: Antacids**Proposed RuleDate*FR* CitationProposed Rule: Amends 21 CFR part 331 to allow overindulgence claims for antacids12/24/199156FR66754**Food and Drink Overindulgence Drug Products: Bismuth Subsalicylate**Proposed RuleDate*FR* CitationProposed Rule: Requires Reye syndrome warning5/5/199358FR26886Proposed Rule: Adds "upset stomach" claim1/5/200570FR741**Food and Drink Overindulgence Drug Products: Stimulants**Proposed RuleDate*FR* CitationProposed Rule: Amends 21 CFR part 340 to allow stimulant and internal analgesic combinations12/24/199156FR66758Correction2/24/199257FR6352Back to Top

                                                                                  Content current as of:
      06/15/2017Historical 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