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 Antiperspirant Drug ProductsHistorical Status of OTC Rulemakings Rulemaking History for OTC Antiperspirant Drug Products
  
  	
    Share
    Post
    Linkedin

    Email
    Print**Final Monograph** (21 CFR part 350):*Antiperspirant Drug Products for Over-the-Counter Human Use*

OTC Antiperspirant Drug Products found on this page:

Original Active Ingredients and Labeling
	Nonmonograph Ingredients
	Zirconium**Antiperspirant Drug Products: Original Active Ingredients and Labeling**

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationAdvance Notice of Proposed Rulemaking
			10/10/1978
			43FR46694Correction
			11/7/1978
			43FR51806Correction
			12/29/1978
			43FR60957Reopening of Administrative Record
			3/21/1980
			45FR18403Request for Comments: Petitions regarding aluminum-containing products
			3/23/1993
			58FR15452Extension of Comment Period
			7/19/1993
			58FR38541Proposed Rule
			Date
			*FR* CitationTentative Final Monograph
			8/20/1982
			47FR36492Final Rule
			Date
			*FR* CitationFinal Monograph
			6/9/2003
			68FR34273Partial Stay; Reopening of Administrative Record
			10/15/2004
			69FR61148**Antiperspirant Drug Products: Nonmonograph Ingredients**

Proposed Rule
			Date
			*FR* CitationProposed Rule: Classifies category II and III ingredients without data as nonmonograph
			5/16/1990
			55FR20434Correction
			6/7/1990
			55FR23235Final Rule
			Date
			*FR* CitationFinal Rule: Classifies category II and III ingredients without data as nonmonograph
			11/7/1990
			55FR46914Correction
			12/3/1990
			55FR49973Technical Amendment: Corrects an ingredient name
			1/30/1992
			57FR3526

**Antiperspirant Drug Products: Zirconium**

Proposed Rule
			Date
			*FR* CitationProposed Rule: Classifies zirconium aerosols as nonmonograph
			6/5/1975
			40FR24328Correction
			6/13/1975
			40FR25218Extension of Comment Period
			8/21/1975
			40FR36574Final Rule
			Date
			*FR* CitationFinal Rule
			8/16/1977
			42FR41374

Back to Top

                                                                                  Content current as of:
      04/24/2017Historical 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