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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 Internal Analgesic Drug ProductsHistorical Status of OTC Rulemakings Rulemaking History for OTC Internal Analgesic Drug Products
  
  	
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    Print**Final Monograph**(21 CFR part 343)**:***Internal Analgesic, Antipyretic, Antirheumatic Drug Products for Over-the-Counter Human Use*

OTC Internal Analgesic Drug Products found on this page:

Original Active Ingredients and Labeling
	Nonmonograph Ingredients
	Ibuprofen
	Professional Labeling
	Related FTC Rulemakings
	Phenacetin
	Alcohol Warning
	Reye's Syndrome Warning
	Upset Stomach/Overindulgence
	Stomach Bleeding & Liver Warning**Internal Analgesic Drug Products: Original Active Ingredients and Labeling**

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationAdvance Notice of Proposed Rulemaking
			7/8/1977
			42FR35346Extension of Comment Period
			10/4/1977
			42FR53980Extension of Comment Period
			1/6/1978
			43FR1100Reopening of Administrative Record
			3/21/1980
			45FR18401Proposed Rule
			Date
			*FR* CitationTentative Final Monograph
			11/16/1988
			53FR46204Correction
			2/3/1989
			54FR5576Extension of Comment Period
			1/16/1990
			55FR1471Notice: Advisory Committee meeting on indications
			7/11/1994
			59FR35375Request for Comments
			7/22/1994
			59FR37421Notice: Amendment of Advisory Committee meeting agenda
			8/16/1994
			59FR42060Notice: Allows marketing of antacid and acetaminophen combinations
			2/5/1992
			57FR4456Correction
			2/20/1992
			57FR6165Correction
			2/28/1992
			57FR6892Final Rule
			Date
			*FR* CitationNotice: Withdraws 4/5/1967 Proposed Rule (withdraws obsolete proposed rules)
			6/5/1984
			49FR23194Final Rule: Classifies atropine and ephedrine ingredients as nonmonograph
			8/24/1998
			63FR44996

**Internal Analgesic Drug Products: Nonmonograph Ingredients**

Proposed Rule
			Date
			*FR* CitationProposed Rule: Classifies category II and III ingredients without data as nonmonograph
			8/25/1992
			57FR38568Correction
			9/8/1992
			57FR40944Correction
			11/9/1992
			57FR53300Final Rule
			Date
			*FR* CitationFinal Rule: Classifies category II and III ingredients without data as nonmonograph
			5/10/1993
			58FR27636Technical Amendment: Correct an ingredient name
			10/1/1992
			57FR45295

**Internal Analgesic Drug Products: Ibuprofen**

Proposed Rule
			Date
			*FR* CitationProposed Rule: Adds ibuprofen as GRASE active ingredient
			8/21/2002
			67FR54139Reopening of Comment Period
			6/4/2003
			68FR33429

**Internal Analgesic Drug Products: Professional Labeling**

Proposed Rule
			Date
			*FR* CitationProposed Rule: Aspirin professional labeling (suspected myocardial infarction)
			6/13/1996
			61FR30002Final Rule
			Date
			*FR* CitationFinal Rule
			10/23/1998
			63FR56802Technical Amendment
			9/14/1999
			64FR49652

**Internal Analgesic Drug Products: Related FTC Rulemakings**

Proposed Rule
			Date
			*FR* CitationProposed Rule: Prohibits comparative effectiveness claims
			4/29/1983
			48FR19360Final Rule
			Date
			*FR* CitationFinal Rule: Prohibits comparative effectiveness claims (Bristol Myers)
			7/29/1983
			48FR34419Final Rule: Prohibits comparative effectiveness claims (Sterling Drug)
			7/29/1983
			48FR34424

**Internal Analgesic Drug Products: Phenacetin**

Proposed Rule
			Date
			*FR* CitationNotice: Hearing on NDA withdrawal
			8/10/1982
			47FR34636Final Rule
			Date
			*FR* CitationNotice: NDA withdrawal
			10/5/1983
			48FR45466

**Internal Analgesic Drug Products: Alcohol Warning**

Proposed Rule
			Date
			*FR* CitationProposed Rule: Requires warning
			11/14/1997
			62FR61041Final Rule
			Date
			*FR* CitationFinal Rule
			10/23/1998
			63FR56789Notice: Extension of compliance date
			3/17/1999
			64FR13066

**Internal Analgesic Drug Products: Reye's Syndrome Warning**

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationAdvance Notice of Proposed Rulemaking
			12/28/1982
			47FR57886Correction
			1/21/1983
			48FR2789Proposed Rule
			Date
			*FR* CitationProposed Rule: Requires warning for aspirin
			12/17/1985
			50FR51400Proposed Rule: Makes warning permanent requirement
			1/22/1988
			53FR1796Proposed Rule: Requires warning for nonaspirin salicylate-containing drugs
			10/20/1993
			58FR54228Final Rule
			Date
			*FR* CitationFinal Rule: Requires warning for aspirin
			3/7/1986
			51FR8180Final Rule: Makes warning permanent requirement
			6/9/1988
			53FR21633Correction
			6/30/1988
			53FR24830Final Rule: Requires warning for nonaspirin salicylate-containing drugs
			4/17/2003
			68FR18861

**Internal Analgesic Drug Products: Upset Stomach/Overindulgence**

Proposed Rule
			Date
			*FR* CitationProposed Rule: Adds indication
			12/24/1991
			56FR66762Proposed Rule: Sodium bicarbonate stomach rupture (overindulgence)
			2/2/1994
			59FR5068Reopening of Comment Period
			4/19/1994
			59FR18507

Internal Analgesic Drug Products: Stomach Bleeding & Liver Warning

Proposed Rule
			Date
			*FR* CitationProposed Rule: Adds liver and stomach bleeding warnings, removes alcohol warning, and adds additional NSAID labeling
			12/26/2006
			71FR77314Final Rule
			Date
			*FR* CitationFinal Rule: Organ-Specific Warnings and Related Labeling
			4/29/2009
			74FR19385Correction
			6/30/2009
			74FR31177Technical Amendment
			11/25/2009
			74FR61512Notice: Availability of Guidance
			     Guidance
			8/17/2010
			75FR50770

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                                                                                  Content current as of:
      02/04/2020Historical Status of OTC Rulemakings
 
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