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HHS/FDA RIN: 0910-AF36 Publication ID: Fall 2010 
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. The first action addresses products labeled to relieve upset stomach associated with overindulgence in food and drink and to relieve symptoms associated with a hangover. The second action addresses acetaminophen safety. The third action addresses products marketed for children under 2 years old and weight- and age-based dosing for children's products. The fourth action addresses combination products containing the analgesic acetaminophen or aspirin and sodium bicarbonate used as an antacid ingredient. The last document finalizes the internal analgesic products monograph. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
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 331    21 USC 351 to 353    21 USC 355    21 USC 360    21 USC 371    21 USC 374    21 USC 379e   
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    
Final Action (Required Warnings and Other Labeling)  04/29/2009  74 FR 19385   
Final Action (Correction)  06/30/2009  74 FR 31177   
Final Action (Technical Amendment)  11/25/2009  74 FR 61512   
NPRM (Acetaminophen)  03/00/2011    
NPRM (Amendment) (Pediatric)  To Be Determined    
NPRM (Amendment) (Sodium Bicarbonate)  To Be Determined    
NPRM (Overindulgence/Hangover)  To Be Determined    
Final Action (Internal Analgesics)  To Be Determined    
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Local, State 
Small Entities Affected: Businesses  Federalism: Yes 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: Yes 
Related RINs: Split from 0910-AA01 
Agency Contact:
Walter J. Ellenberg
Regulatory Project Management Officer
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, WO-22, Room 5488, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-2090
Fax:301 796-9899
Email: walter.ellenberg@fda.hhs.gov