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Rulemaking History for OTC Antitussive Drug Products

Final Monograph (21 CFR part 341):
Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use
 

OTC Antitussive Drug Products found on this page:


Antitussive Drug Products: Original Active Ingredients and Labeling
Advance Notice Of Proposed RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking [PDF]9/9/197641FR38312
Reopening of Administrative Record [PDF]3/21/198045FR18400
Reopening of Administrative Record: Camphor-containing products [PDF]9/26/198045FR63874
Notice: Advisory Committee meeting [PDF]4/29/198348FR19470
Notice: Republication of 4/29/1983 notice [PDF]5/6/198348FR20502
Proposed RuleDateFR Citation
Tentative Final Monograph [PDF]10/19/198348FR48576
    Correction [PDF]11/16/198348FR52079
Final RuleDateFR Citation
Final Monograph [PDF]8/12/198752FR30042
    Correction [PDF]9/9/198752FR34047
    Correction [PDF]9/22/198752FR35610
Technical Amendment: Clarifies age range for children's dosage [PDF]9/15/198853FR35808
Technical Amendment: Removes carbetapentane citrate from 21CFR310.201(a)(20) [PDF]11/30/200772FR67639

Antitussive Drug Products: Benylin
Proposed RuleDateFR Citation
Notice: Hearing on unapproved NDA [PDF]11/30/197641FR52537
Final RuleDateFR Citation
Final Decision [PDF]8/31/197944FR51512
    Correction [PDF]10/2/197944FR56744

Antitussive Drug Products: Camphor and Menthol
Proposed RuleDateFR Citation
Proposed Rule: Revises warning and directions for topical/inhalant products [PDF]7/20/199863FR38762
Final RuleDateFR Citation
Final Rule [PDF]8/1/200065FR46864

Antitussive Drug Products: Combination Products
Proposed RuleDateFR Citation
Proposed Rule [PDF]8/12/198853FR30522
    Clarification: Promethazine HCl combinations [PDF]11/14/198853FR45774
Notice: Bans interim marketing of promethazine HCl combinations [PDF]9/5/198954FR36762
Reopening of Administrative Record: Promethazine HCl combinations [PDF]11/28/198954FR48914
    Correction [PDF]1/4/199055FR310
    Extension of Comment Period [PDF]1/24/199055FR2387
Final RuleDateFR Citation
Final Rule [PDF]12/23/200267FR78158
    Technical Amendment: Correction [PDF]3/19/200772FR12730

Antitussive Drug Products: Dextromethorphan
Proposed RuleDateFR Citation
Proposed Rule: Monoamine oxidase inhibitor (MAOI) warning [PDF]6/19/199257FR27666
    Extension of Comment Period [PDF]8/6/199257FR34735
Final RuleDateFR Citation
Final Rule [PDF]10/20/199358FR54232
Notice: Advisory Committee Meeting5/4/201075FR23782

Antitussive Drug Products: Diphenhydramine HCl and Citrate
Proposed RuleDateFR Citation
Proposed Rule: Adds diphenhydramine HCl & diphenhydramine citrate as GRASE ingredients [PDF]12/9/199257FR58378
Proposed Rule: Classifies diphenhydramine combinations as GRASE or nonmonograph [PDF]2/23/199560FR10286
Proposed Rule: Requires warnings on all diphenhydramine products [PDF]8/29/199762FR45767
Final RuleDateFR Citation
Final Rule: Adds diphenhydramine HCl & diphenhydramine citrate as GRASE ingredients [PDF]6/3/199459FR29172
     Correction [PDF]7/15/199459FR36051
Final Rule: Allows interim marketing of combinations [PDF]4/9/199661FR15700
Final Rule: Requires warnings on all diphenhydramine products [PDF]12/6/200267FR72555

Antitussive Drug Products: Menthol Lozenge
Proposed RuleDateFR Citation
Proposed Rule: Exempts "accidental overdose" warning [PDF]7/6/198954FR28442
Proposed Rule: Allows and defines "lozenge" as solid dose [PDF]10/2/198954FR40412
Final RuleDateFR Citation
Final Rule: Exempts "accidental overdose" warning [PDF]7/6/199055FR27806
Final Rule: Allows and defines "lozenge" as solid dose [PDF]10/3/199055FR40381

Antitussive Drug Products: Pediatric Use
Proposed RuleDateFR Citation
Notice: Advisory Committee Meeting [PDF]8/16/200772FR46091
Amendment of Notice: Advisory Committee Meeting [PDF]10/1/200772FR55784
Notice of Public Hearing: Request for comments [PDF]8/25/200873FR50033
Notice of Public Hearing: Correction [PDF]9/2/200873FR51309

Antitussive Drug Products: Phenylpropanolamine (PPA)
Proposed RuleDateFR Citation
Proposed Rule: Clarifies dosage [PDF]10/28/197742FR56756
Notice: Advisory Committee meeting [PDF]8/30/200065FR52775
Notice: Hearing on NDA withdrawal [PDF]8/14/200166FR42665