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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 Antitussive Drug ProductsHistorical Status of OTC Rulemakings Rulemaking History for OTC Antitussive 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 Antitussive Drug Products found on this page:

Original Active Ingredients and Labeling
	Benylin
	Camphor and Menthol
	Combination Products
	Dextromethorphan
	Diphenhydramine HCl and Citrate
	Menthol Lozenge
	Pediatric Use
	Phenylpropanolamine (PPA)**Antitussive 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
			45FR18400Reopening of Administrative Record: Camphor-containing products [PDF]
			9/26/1980
			45FR63874Notice: Advisory Committee meeting [PDF]
			4/29/1983
			48FR19470Notice: Republication of 4/29/1983 notice [PDF]
			5/6/1983
			48FR20502Proposed Rule
			Date
			*FR* CitationTentative Final Monograph [PDF]
			10/19/1983
			48FR48576Correction [PDF]
			11/16/1983
			48FR52079Final Rule
			Date
			*FR* CitationFinal Monograph [PDF]
			8/12/1987
			52FR30042Correction [PDF]
			9/9/1987
			52FR34047Correction [PDF]
			9/22/1987
			52FR35610Technical Amendment: Clarifies age range for children's dosage [PDF]
			9/15/1988
			53FR35808Technical Amendment: Removes carbetapentane citrate from 21CFR310.201(a)(20) [PDF]
			11/30/2007
			72FR67639

**Antitussive Drug Products: Benylin**

Proposed Rule
			Date
			*FR* CitationNotice: Hearing on unapproved NDA [PDF]
			11/30/1976
			41FR52537Final Rule
			Date
			*FR* CitationFinal Decision [PDF]
			8/31/1979
			44FR51512Correction [PDF]
			10/2/1979
			44FR56744

**Antitussive Drug Products: Camphor and Menthol**

Proposed Rule
			Date
			*FR* CitationProposed Rule: Revises warning and directions for topical/inhalant products [PDF]
			7/20/1998
			63FR38762Final Rule
			Date
			*FR* CitationFinal Rule [PDF]
			8/1/2000
			65FR46864

**Antitussive Drug Products: Combination Products**

Proposed Rule
			Date
			*FR* CitationProposed Rule [PDF]
			8/12/1988
			53FR30522Clarification: Promethazine HCl combinations [PDF]
			11/14/1988
			53FR45774Notice: Bans 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 [PDF]
			12/23/2002
			67FR78158Technical Amendment: Correction [PDF]
			3/19/2007
			72FR12730

**Antitussive Drug Products: Dextromethorphan**

Proposed Rule
			Date
			*FR* CitationProposed Rule: Monoamine oxidase inhibitor (MAOI) warning [PDF]
			6/19/1992
			57FR27666Extension of Comment Period [PDF]
			8/6/1992
			57FR34735Final Rule
			Date
			*FR* CitationFinal Rule [PDF]
			10/20/1993
			58FR54232Notice: Advisory Committee Meeting
			5/4/2010
			75FR23782

**Antitussive Drug Products: Diphenhydramine HCl and Citrate**

Proposed Rule
			Date
			*FR* CitationProposed Rule: Adds diphenhydramine HCl & diphenhydramine citrate as GRASE ingredients [PDF]
			12/9/1992
			57FR58378Proposed Rule: Classifies diphenhydramine combinations as GRASE or nonmonograph [PDF]
			2/23/1995
			60FR10286Proposed Rule: Requires warnings on all diphenhydramine products [PDF]
			8/29/1997
			62FR45767Final Rule
			Date
			*FR* CitationFinal Rule: Adds diphenhydramine HCl & diphenhydramine citrate as GRASE ingredients [PDF]
			6/3/1994
			59FR29172Correction [PDF]
			7/15/1994
			59FR36051Final Rule: Allows interim marketing of combinations [PDF]
			4/9/1996
			61FR15700Final Rule: Requires warnings on all diphenhydramine products [PDF]
			12/6/2002
			67FR72555

**Antitussive Drug Products: Menthol Lozenge**

Proposed Rule
			Date
			*FR* CitationProposed Rule: Exempts "accidental overdose" warning [PDF]
			7/6/1989
			54FR28442Proposed Rule: Allows and defines "lozenge" as solid dose [PDF]
			10/2/1989
			54FR40412Final Rule
			Date
			*FR* CitationFinal Rule: Exempts "accidental overdose" warning [PDF]
			7/6/1990
			55FR27806Final Rule: Allows and defines "lozenge" as solid dose [PDF]
			10/3/1990
			55FR40381

**Antitussive Drug Products: Pediatric Use**

Proposed Rule
			Date
			*FR* CitationNotice: Advisory Committee Meeting [PDF]
			8/16/2007
			72FR46091Amendment of Notice: Advisory Committee Meeting [PDF]
			10/1/2007
			72FR55784Notice of Public Hearing: Request for comments [PDF]
			8/25/2008
			73FR50033Notice of Public Hearing: Correction [PDF]
			9/2/2008
			73FR51309

**Antitussive Drug Products: Phenylpropanolamine (PPA)**

Proposed Rule
			Date
			*FR* CitationProposed Rule: Clarifies dosage [PDF]
			10/28/1977
			42FR56756Notice: Advisory Committee meeting [PDF]
			8/30/2000
			65FR52775Notice: Hearing on NDA withdrawal [PDF]
			8/14/2001
			66FR42665

                                                                                  Content current as of:
      03/08/2017Historical Status of OTC Rulemakings
 
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