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HHS/FDA RIN: 0910-AF36 Publication ID: Spring 2007 
Title: Over-the-Counter (OTC) Drug Review--Internal Analgesic Products 
Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. One action addresses labeling intended to better inform consumers of potential risks associated with these products. The second action addresses products marketed for children under 2 years old and weight- and age-based dosing for children's products. The third action addresses combination products containing the analgesic acetaminophen or aspirin and sodium bicarbonate used as an antacid ingredient. The fourth action addresses products labeled to relieve upset stomach associated with overindulgence in food and drink and to relieve symptoms associated with a hangover. The Stevens Johnson and Cardiovascular Warnings documents address new proposed product warnings. 
Agency: Department of Health and Human Services(HHS)  Priority: Routine and Frequent 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 358 
Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 360a; 21 USC 371a; 21 USC 331; 21 USC 360; 21 USC 360gg to 360ss; 21 USC 371; 21 USC 374; 21 USC 379e; 42 USC 216; 42 USC 241; 42 USC 262; 42 USC 264 
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM (Amendment) (Required Warnings and Other Labeling)  12/26/2006  71 FR 77314 
NPRM Comment Period End  05/25/2007   
NPRM (Amendment) (Overindulgence/Hangover)  10/00/2007   
NPRM (Amendment) (Pediatric)  12/00/2007   
NPRM (Amendment) (Combinations with Sodium Bicarbonate)  12/00/2007   
NPRM (Amendment) (Safety)  12/00/2007   
Final Action (Internal Analgesics)  06/00/2008   
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Local, State 
Small Entities Affected: Businesses  Federalism: Yes 
Included in the Regulatory Plan: No 
Related RINs: Split from 0910-AA01 
Agency Contact:
Gerald M. Rachanow
Regulatory Counsel, Division of Over-the-Counter Drug Products
Department of Health and Human Services
Food and Drug Administration
HFD-560, Center for Drug Evaluation and Research (HFD-560), 5600 Fishers Lane,
Rockville, MD 20857
Phone:301 827-2241
Fax:301 827-2315
Email: gerald.rachanow@fda.hhs.gov

 
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