Drugs

Rulemaking History for OTC Internal Analgesic Drug Products

Final Monograph (21 CFR part 343):
Internal Analgesic, Antipyretic, Antirheumatic Drug Products for Over-the-Counter Human Use

OTC Internal Analgesic Drug Products found on this page:


Internal Analgesic Drug Products: Original Active Ingredients and Labeling

Advance Notice Of Proposed RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking 7/8/197742FR35346disclaimer icon
    Extension of Comment Period 10/4/197742FR53980disclaimer icon
    Extension of Comment Period 1/6/197843FR1100disclaimer icon
Reopening of Administrative Record 3/21/198045FR18401disclaimer icon
Proposed RuleDateFR Citation
Tentative Final Monograph 11/16/198853FR46204disclaimer icon
    Correction 2/3/198954FR5576disclaimer icon
    Extension of Comment Period 1/16/199055FR1471disclaimer icon
 Notice: Advisory Committee meeting on indications7/11/199459FR35375
    Request for Comments 7/22/199459FR37421
    Notice: Amendment of Advisory Committee meeting agenda8/16/199459FR42060
Notice: Allows marketing of antacid and acetaminophen combinations2/5/199257FR4456disclaimer icon
    Correction 2/20/199257FR6165disclaimer icon
   Correction 2/28/199257FR6892disclaimer icon
Final RuleDateFR Citation
Notice: Withdraws 4/5/1967 Proposed Rule (withdraws obsolete proposed rules)6/5/198449FR23194disclaimer icon
Final Rule: Classifies atropine and ephedrine ingredients as nonmonograph8/24/199863FR44996

Internal Analgesic Drug Products: Nonmonograph Ingredients

Proposed RuleDateFR Citation
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph8/25/199257FR38568disclaimer icon
    Correction 9/8/199257FR40944disclaimer icon
    Correction 11/9/199257FR53300disclaimer icon
Final RuleDateFR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph5/10/199358FR27636disclaimer icon
Technical Amendment: Correct an ingredient name10/1/199257FR45295disclaimer icon

Internal Analgesic Drug Products: Ibuprofen

Proposed RuleDateFR Citation
Proposed Rule: Adds ibuprofen as GRASE active ingredient8/21/200267FR54139
    Reopening of Comment Period 6/4/200368FR33429

Internal Analgesic Drug Products: Professional Labeling

Proposed RuleDateFR Citation
Proposed Rule: Aspirin professional labeling (suspected myocardial infarction)6/13/199661FR30002
Final RuleDateFR Citation
Final Rule 10/23/199863FR56802
    Technical Amendment9/14/199964FR49652

Internal Analgesic Drug Products: Related FTC Rulemakings

Proposed RuleDateFR Citation
Proposed Rule: Prohibits comparative effectiveness claims4/29/198348FR19360disclaimer icon
Final RuleDateFR Citation
Final Rule: Prohibits comparative effectiveness claims (Bristol Myers)7/29/198348FR34419disclaimer icon
Final Rule: Prohibits comparative effectiveness claims (Sterling Drug)7/29/198348FR34424disclaimer icon

Internal Analgesic Drug Products: Phenacetin

Proposed RuleDateFR Citation
Notice: Hearing on NDA withdrawal8/10/198247FR34636disclaimer icon
Final RuleDateFR Citation
Notice: NDA withdrawal10/5/198348FR45466disclaimer icon

Internal Analgesic Drug Products: Alcohol Warning

Proposed RuleDateFR Citation
 Proposed Rule: Requires warning11/14/199762FR61041
Final RuleDateFR Citation
Final Rule10/23/199863FR56789
    Notice: Extension of compliance date3/17/199964FR13066

Internal Analgesic Drug Products: Reye's Syndrome Warning

Advance Notice Of Proposed RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking 12/28/198247FR57886disclaimer icon
    Correction 1/21/198348FR2789disclaimer icon
Proposed RuleDateFR Citation
Proposed Rule: Requires warning for aspirin12/17/198550FR51400disclaimer icon
Proposed Rule: Makes warning permanent requirement1/22/198853FR1796disclaimer icon
Proposed Rule: Requires warning for nonaspirin salicylate-containing drugs10/20/199358FR54228
Final RuleDateFR Citation
Final Rule: Requires warning for aspirin3/7/198651FR8180disclaimer icon
Final Rule: Makes warning permanent requirement6/9/198853FR21633disclaimer icon
    Correction 6/30/198853FR24830disclaimer icon
Final Rule: Requires warning for nonaspirin salicylate-containing drugs4/17/200368FR18861

Internal Analgesic Drug Products: Upset Stomach/Overindulgence

Proposed RuleDateFR Citation
Proposed Rule: Adds indication12/24/199156FR66762disclaimer icon
Proposed Rule: Sodium bicarbonate stomach rupture (overindulgence)2/2/199459FR5068
    Reopening of Comment Period 4/19/199459FR18507

Internal Analgesic Drug Products: Stomach Bleeding & Liver Warning

Proposed RuleDateFR Citation
Proposed Rule: Adds liver and stomach bleeding warnings, removes alcohol warning, and adds additional NSAID labeling12/26/200671FR77314
Final RuleDateFR Citation
 Final Rule: Organ-Specific Warnings and Related Labeling4/29/200974FR19385
Correction6/30/200974FR31177
Technical Amendment11/25/200974FR61512
Notice: Availability of Guidance
     Guidance
8/17/201075FR50770

 

Page Last Updated: 02/08/2017
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