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 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 Antihistamine Drug ProductsHistorical Status of OTC Rulemakings Rulemaking History for OTC Antihistamine Drug Products
  
  	
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    Print**Final Monograph**(21 CFR part 341)**:***Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use*



OTC Antihistamine Drug Products found on this page:

Original Active Ingredients and Labeling
	Nonmonograph Ingredients
	Chlorcyclizine HCl, Doxylamine Succinate, and Triprolidine HCl
	Combination Products
	Common Cold
	Diphenhydramine Warnings
	Phenylpropanolamine (PPA)
	Pediatric Use**Antihistamine Drug Products: Original Active Ingredients and Labeling**
	Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationAdvance Notice of Proposed Rulemaking [PDF]
			9/9/1976
			41FR38312Reopening of Administrative Record [PDF]
			3/21/1980
			45FR18400Proposed Rule
			Date
			*FR* CitationTentative Final Monograph [PDF]
			1/15/1985
			50FR2200Correction [PDF]
			2/14/1985
			50FR6199Correction [PDF]
			3/6/1985
			50FR9040Proposed Rule: Classifies category II and III ingredients without data as nonmonograph [PDF]
			5/16/1990
			55FR20434Correction [PDF]
			6/7/1990
			55FR23235Final Rule
			Date
			*FR* CitationFinal Rule: Classifies category II and III ingredients without data as nonmonograph [PDF]
			11/7/1990
			55FR46914Correction [PDF]
			12/3/1990
			55FR49973Technical Amendment: Correct an ingredient name [PDF]
			1/30/1992
			57FR3526Final Monograph [PDF]
			12/9/1992
			57FR58356**Antihistamine Drug Products: Nonmonograph Ingredients**
	Proposed Rule
			Date
			*FR* CitationProposed Rule: Classifies category II and III ingredients without data as nonmonograph [PDF]
			5/16/1990
			55FR20434Correction [PDF]
			6/7/1990
			55FR23235Final Rule
			Date
			*FR* CitationFinal Rule: Classifies category II and III ingredients without data as nonmonograph [PDF]
			11/7/1990
			55FR46914Correction [PDF]
			12/3/1990
			55FR49973Technical Amendment: Corrects an ingredient name [PDF]
			1/30/1992
			57FR3526**Antihistamine Drug Products: Chlorcyclizine HCl, Doxylamine Succinate, and Triprolidine HCl**
	Proposed Rule
			Date
			*FR* CitationProposed Rule [PDF]
			8/24/1987
			52FR31892Correction [PDF]
			9/22/1987
			52FR35610Final Rule
			Date
			*FR* CitationFinal Rule [PDF]
			1/28/1994
			59FR4216Correction [PDF]
			2/14/1997
			62FR6866**Antihistamine Drug Products: Combination Products**
	Proposed Rule
			Date
			*FR* CitationProposed Rule [PDF]
			8/12/1988
			53FR30522Clarification: Promethazine HCl combinations [PDF]
			11/14/1988
			53FR45774Proposed Rule: Diphenhydramine citrate and HCl combinations [PDF]
			2/23/1995
			60FR10286Notice: Prohibits interim marketing of promethazine HCl combinations [PDF]
			9/5/1989
			54FR36762Reopening of Administrative Record: Promethazine HCl combinations [PDF]
			11/28/1989
			54FR48914Correction [PDF]
			1/4/1990
			55FR310Extension of Comment Period [PDF]
			1/24/1990
			55FR2387Final Rule
			Date
			*FR* CitationFinal Rule: Diphenhydramine citrate and HCl combinations [PDF]
			4/9/1996
			61FR15700Final Rule [PDF]
			12/23/2002
			67FR78158Technical Amendment: Correction [PDF]
			3/19/2007
			72FR12730**Antihistamine Drug Products: Common Cold**
	Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationReopening of Administrative Record [PDF]
			8/25/2000
			65FR51780**Antihistamine Drug Products: Diphenhydramine Warnings**
	Proposed Rule
			Date
			*FR* CitationProposed Rule [PDF]
			8/29/1997
			62FR45767Final Rule
			Date
			*FR* CitationFinal Rule [PDF]
			12/6/2002
			67FR72555**Antihistamine Drug Products: Phenylpropanolamine (PPA)**
	Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationNotice: Advisory Committee meeting [PDF]
			8/30/2000
			65FR52775Notice: Hearing on NDA withdrawal [PDF]
			8/14/2001
			66FR42665**Antihistamine Drug Products: Pediatric Use**
	Proposed Rule
			Date
			*FR* CitationNotice: Advisory Committee Meeting [PDF]
			8/16/2007
			72FR46091Notice of Public Hearing: Request for comments [PDF]
			8/25/2008
			73FR50033Notice of Public Hearing: Correction [PDF]
			9/2/2008
			73FR51309

                                                                                  Content current as of:
      03/01/2022Historical Status of OTC Rulemakings
 
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