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  6. Historical Status of OTC Rulemakings
  7. Rulemaking History for OTC Antitussive Drug Products
  1. Historical Status of OTC Rulemakings

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 41FR38312
Reopening of Administrative Record [PDF] 3/21/1980 45FR18400
Reopening of Administrative Record: Camphor-containing products [PDF] 9/26/1980 45FR63874
Notice: Advisory Committee meeting [PDF] 4/29/1983 48FR19470
Notice: Republication of 4/29/1983 notice [PDF] 5/6/1983 48FR20502
Proposed Rule Date FR Citation
Tentative Final Monograph [PDF] 10/19/1983 48FR48576
    Correction [PDF] 11/16/1983 48FR52079
Final Rule Date FR Citation
Final Monograph [PDF] 8/12/1987 52FR30042
    Correction [PDF] 9/9/1987 52FR34047
    Correction [PDF] 9/22/1987 52FR35610
Technical Amendment: Clarifies age range for children's dosage [PDF] 9/15/1988 53FR35808
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 41FR52537
Final Rule Date FR Citation
Final Decision [PDF] 8/31/1979 44FR51512
    Correction [PDF] 10/2/1979 44FR56744

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 53FR30522
    Clarification: Promethazine HCl combinations [PDF] 11/14/1988 53FR45774
Notice: Bans interim marketing of promethazine HCl combinations [PDF] 9/5/1989 54FR36762
Reopening of Administrative Record: Promethazine HCl combinations [PDF] 11/28/1989 54FR48914
    Correction [PDF] 1/4/1990 55FR310
    Extension of Comment Period [PDF] 1/24/1990 55FR2387
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 57FR27666
    Extension of Comment Period [PDF] 8/6/1992 57FR34735
Final Rule Date FR Citation
Final Rule [PDF] 10/20/1993 58FR54232
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 57FR58378
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 54FR28442
Proposed Rule: Allows and defines "lozenge" as solid dose [PDF] 10/2/1989 54FR40412
Final Rule Date FR Citation
Final Rule: Exempts "accidental overdose" warning [PDF] 7/6/1990 55FR27806
Final Rule: Allows and defines "lozenge" as solid dose [PDF] 10/3/1990 55FR40381

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 42FR56756
Notice: Advisory Committee meeting [PDF] 8/30/2000 65FR52775
Notice: Hearing on NDA withdrawal [PDF] 8/14/2001 66FR42665

 

 
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