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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 Nighttime Sleep-Aid Drug ProductsHistorical Status of OTC Rulemakings Rulemaking History for OTC Nighttime Sleep-Aid Drug Products
  
  	
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    Print**Final Monograph**(21 CFR part 338)*Nighttime Sleep-Aid Drug Products for Over-the-Counter Human Use*

OTC Nighttime Sleep-Aid Drug Products found on this page:

Original Active Ingredients and Labeling
	Diphenhydramine**Nighttime Sleep-Aid Drug Products: Original Active Ingredients and Labeling**

Advance Notice Of Proposed Rulemaking
			Date
			*FR* CitationAdvance Notice of Proposed Rulemaking
			12/8/1975
			40FR57292Correction
			1/8/1976
			41FR1498Correction
			1/26/1976
			41FR3745Correction
			1/30/1976
			41FR4600Reopening of Administrative Record: Category II and III ingredients
			10/26/1979
			44FR61611Correction
			11/16/1979
			44FR65992Proposed Rule
			Date
			*FR* CitationTentative Final Monograph
			6/13/1978
			43FR25544Reopening of Administrative Record
			3/21/1980
			45FR18399Final Rule
			Date
			*FR* CitationFinal Monograph
			2/14/1989
			54FR6814

**Nighttime Sleep-Aid Drug Products: Diphenhydramine**

Proposed Rule
			Date
			*FR* CitationTentative Final Monograph
			6/13/1978
			43FR25544Notice: Allows marketing of diphenhydramine
			4/23/1982
			47FR17740Proposed Rule: Revises warnings to be consistent with antihistamines and antitussives
			8/26/1993
			58FR45217Proposed Rule: Requires overdose warnings (also antiemetics, antihistamines, and antitussives)
			8/27/1997
			62FR45767Final Rule
			Date
			*FR* CitationFinal Rule: Revises warnings to be consistent with antihistamines and antitussives
			4/11/1994
			59FR16982Final Rule: Requires overdose warnings (also antiemetics, antihistamines, and antitussives)
			12/6/2002
			67FR72555

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                                                                                  Content current as of:
      02/28/2022Historical Status of OTC Rulemakings
 
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