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U.S. Department of Health and Human Services

Drugs

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Rulemaking History for OTC Nighttime Sleep-Aid Drug Products

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:


Nighttime Sleep-Aid Drug Products: Original Active Ingredients and Labeling
Advance Notice Of Proposed Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking [PDF] 12/8/1975 40FR57292
    Correction [PDF] 1/8/1976 41FR1498
    Correction [PDF] 1/26/1976 41FR3745
    Correction [PDF] 1/30/1976 41FR4600
Reopening of Administrative Record:Category II and III ingredients [PDF] 10/26/1979 44FR61611
    Correction [PDF] 11/16/1979 44FR65992
Proposed Rule Date FR Citation
Tentative Final Monograph [PDF] 6/13/1978 43FR25544
     Reopening of Administrative Record [PDF] 3/21/1980 45FR18399
Final Rule Date FR Citation
Final Monograph [PDF] 2/14/1989 54FR6814

Nighttime Sleep-Aid Drug Products: Diphenhydramine
Proposed Rule Date FR Citation
Tentative Final Monograph [PDF] 6/13/1978 43FR25544
Notice: Allows marketing of diphenhydramine [PDF] 4/23/1982 47FR17740
Proposed Rule: Revises warnings to be consistent with antihistamines and antitussives [PDF] 8/26/1993 58FR45217
Proposed Rule: Requires overdose warnings (also antiemetics, antihistamines, and antitussives) [PDF] 8/29/1997 62FR45767
Final Rule Date FR Citation
Final Rule: Revises warnings to be consistent with antihistamines and antitussives [PDF] 4/11/1994 59FR16982
Final Rule: Requires overdose warnings (also antiemetics, antihistamines, and antitussives) [PDF] 12/6/2002 67FR72555
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