Drugs

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 Rulemaking Date FR Citation
Advance Notice of Proposed Rulemaking [PDF] 9/9/1976 41FR38312disclaimer icon
Reopening of Administrative Record [PDF] 3/21/1980 45FR18400disclaimer icon
Reopening of Administrative Record: Camphor-containing products [PDF] 9/26/1980 45FR63874disclaimer icon
Notice: Advisory Committee meeting [PDF] 4/29/1983 48FR19470disclaimer icon
Notice: Republication of 4/29/1983 notice [PDF] 5/6/1983 48FR20502disclaimer icon
Proposed Rule Date FR Citation
Tentative Final Monograph [PDF] 10/19/1983 48FR48576disclaimer icon
    Correction [PDF] 11/16/1983 48FR52079disclaimer icon
Final Rule Date FR Citation
Final Monograph [PDF] 8/12/1987 52FR30042disclaimer icon
    Correction [PDF] 9/9/1987 52FR34047disclaimer icon
    Correction [PDF] 9/22/1987 52FR35610disclaimer icon
Technical Amendment: Clarifies age range for children's dosage [PDF] 9/15/1988 53FR35808disclaimer icon
Technical Amendment: Removes carbetapentane citrate from 21CFR310.201(a)(20) [PDF] 11/30/2007 72FR67639

Antitussive Drug Products: Benylin

Proposed Rule Date FR Citation
Notice: Hearing on unapproved NDA [PDF] 11/30/1976 41FR52537disclaimer icon
Final Rule Date FR Citation
Final Decision [PDF] 8/31/1979 44FR51512disclaimer icon
    Correction [PDF] 10/2/1979 44FR56744disclaimer icon

Antitussive Drug Products: Camphor and Menthol

Proposed Rule Date FR Citation
Proposed Rule: Revises warning and directions for topical/inhalant products [PDF] 7/20/1998 63FR38762
Final Rule Date FR Citation
Final Rule [PDF] 8/1/2000 65FR46864

Antitussive Drug Products: Combination Products

Proposed Rule Date FR Citation
Proposed Rule [PDF] 8/12/1988 53FR30522disclaimer icon
    Clarification: Promethazine HCl combinations [PDF] 11/14/1988 53FR45774disclaimer icon
Notice: Bans interim marketing of promethazine HCl combinations [PDF] 9/5/1989 54FR36762disclaimer icon
Reopening of Administrative Record: Promethazine HCl combinations [PDF] 11/28/1989 54FR48914disclaimer icon
    Correction [PDF] 1/4/1990 55FR310disclaimer icon
    Extension of Comment Period [PDF] 1/24/1990 55FR2387disclaimer icon
Final Rule Date FR Citation
Final Rule [PDF] 12/23/2002 67FR78158
    Technical Amendment: Correction [PDF] 3/19/2007 72FR12730

Antitussive Drug Products: Dextromethorphan

Proposed Rule Date FR Citation
Proposed Rule: Monoamine oxidase inhibitor (MAOI) warning [PDF] 6/19/1992 57FR27666disclaimer icon
    Extension of Comment Period [PDF] 8/6/1992 57FR34735disclaimer icon
Final Rule Date FR Citation
Final Rule [PDF] 10/20/1993 58FR54232disclaimer icon
Notice: Advisory Committee Meeting 5/4/2010 75FR23782

Antitussive Drug Products: Diphenhydramine HCl and Citrate

Proposed Rule Date FR Citation
Proposed Rule: Adds diphenhydramine HCl & diphenhydramine citrate as GRASE ingredients [PDF] 12/9/1992 57FR58378disclaimer icon
Proposed Rule: Classifies diphenhydramine combinations as GRASE or nonmonograph [PDF] 2/23/1995 60FR10286
Proposed Rule: Requires warnings on all diphenhydramine products [PDF] 8/29/1997 62FR45767
Final Rule Date FR Citation
Final Rule: Adds diphenhydramine HCl & diphenhydramine citrate as GRASE ingredients [PDF] 6/3/1994 59FR29172
     Correction [PDF] 7/15/1994 59FR36051
Final Rule: Allows interim marketing of combinations [PDF] 4/9/1996 61FR15700
Final Rule: Requires warnings on all diphenhydramine products [PDF] 12/6/2002 67FR72555

Antitussive Drug Products: Menthol Lozenge

Proposed Rule Date FR Citation
Proposed Rule: Exempts "accidental overdose" warning [PDF] 7/6/1989 54FR28442disclaimer icon
Proposed Rule: Allows and defines "lozenge" as solid dose [PDF] 10/2/1989 54FR40412disclaimer icon
Final Rule Date FR Citation
Final Rule: Exempts "accidental overdose" warning [PDF] 7/6/1990 55FR27806disclaimer icon
Final Rule: Allows and defines "lozenge" as solid dose [PDF] 10/3/1990 55FR40381disclaimer icon

Antitussive Drug Products: Pediatric Use

Proposed Rule Date FR Citation
Notice: Advisory Committee Meeting [PDF] 8/16/2007 72FR46091
Amendment of Notice: Advisory Committee Meeting [PDF] 10/1/2007 72FR55784
Notice of Public Hearing: Request for comments [PDF] 8/25/2008 73FR50033
Notice of Public Hearing: Correction [PDF] 9/2/2008 73FR51309

Antitussive Drug Products: Phenylpropanolamine (PPA)

Proposed Rule Date FR Citation
Proposed Rule: Clarifies dosage [PDF] 10/28/1977 42FR56756disclaimer icon
Notice: Advisory Committee meeting [PDF] 8/30/2000 65FR52775
Notice: Hearing on NDA withdrawal [PDF] 8/14/2001 66FR42665

 

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