Drugs

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 RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking12/8/197540FR57292
    Correction1/8/197641FR1498
    Correction1/26/197641FR3745
    Correction1/30/197641FR4600
Reopening of Administrative Record: Category II and III ingredients10/26/197944FR61611
    Correction11/16/197944FR65992
Proposed RuleDateFR Citation
Tentative Final Monograph6/13/197843FR25544
     Reopening of Administrative Record3/21/198045FR18399
Final RuleDateFR Citation
Final Monograph2/14/198954FR6814

Nighttime Sleep-Aid Drug Products: Diphenhydramine

Proposed RuleDateFR Citation
Tentative Final Monograph6/13/197843FR25544
Notice: Allows marketing of diphenhydramine4/23/198247FR17740
Proposed Rule: Revises warnings to be consistent with antihistamines and antitussives8/26/199358FR45217
Proposed Rule: Requires overdose warnings (also antiemetics, antihistamines, and antitussives)8/29/199762FR45767
Final RuleDateFR Citation
Final Rule: Revises warnings to be consistent with antihistamines and antitussives4/11/199459FR16982
Final Rule: Requires overdose warnings (also antiemetics, antihistamines, and antitussives)12/6/200267FR72555

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Page Last Updated: 01/23/2017
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