Rulemaking History for OTC Nighttime Sleep-Aid Drug Products

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Rulemaking History for OTC Nighttime Sleep-Aid Drug Products
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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:

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

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

Date created: December 28, 2006; Last updated: May 4, 2007