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Rulemaking History for OTC Antihistamine Drug Products

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

OTC Antihistamine Drug Products found on this page:


Antihistamine 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
Proposed Rule Date FR Citation
Tentative Final Monograph [PDF] 1/15/1985 50FR2200
    Correction [PDF] 2/14/1985 50FR6199
    Correction [PDF] 3/6/1985 50FR9040
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph [PDF] 5/16/1990 55FR20434
    Correction [PDF] 6/7/1990 55FR23235
Final Rule Date FR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph [PDF] 11/7/1990 55FR46914
    Correction [PDF] 12/3/1990 55FR49973
    Technical Amendment: Correct an ingredient name [PDF] 1/30/1992 57FR3526
Final Monograph [PDF] 12/9/1992 57FR58356

Antihistamine Drug Products: Nonmonograph Ingredients
Proposed Rule Date FR Citation
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph [PDF] 5/16/1990 55FR20434
    Correction [PDF] 6/7/1990 55FR23235
Final Rule Date FR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph [PDF] 11/7/1990 55FR46914
    Correction [PDF] 12/3/1990 55FR49973
    Technical Amendment: Corrects an ingredient name [PDF] 1/30/1992 57FR3526

Antihistamine Drug Products: Chlorcyclizine HCl, Doxylamine Succinate, and Triprolidine HCl
Proposed Rule Date FR Citation
Proposed Rule [PDF] 8/24/1987 52FR31892
    Correction [PDF] 9/22/1987 52FR35610
Final Rule Date FR Citation
Final Rule [PDF] 1/28/1994 59FR4216
    Correction [PDF] 2/14/1997 62FR6866
 
Antihistamine 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
Proposed Rule: Diphenhydramine citrate and HCl combinations [PDF] 2/23/1995 60FR10286
Notice: Prohibits 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: Diphenhydramine citrate and HCl combinations [PDF] 4/9/1996 61FR15700
Final Rule [PDF] 12/23/2002 67FR78158
    Technical Amendment: Correction [PDF] 3/19/2007 72FR12730

Antihistamine Drug Products: Common Cold
Advance Notice Of Proposed Rulemaking Date FR Citation
Reopening of Administrative Record [PDF] 8/25/2000 65FR51780

Antihistamine Drug Products: Diphenhydramine Warnings
Proposed Rule Date FR Citation
Proposed Rule [PDF] 8/29/1997 62FR45767
Final Rule Date FR Citation
Final Rule [PDF] 12/6/2002 67FR72555

Antihistamine Drug Products: Phenylpropanolamine (PPA)
Advance Notice Of Proposed Rulemaking Date FR Citation
Notice: Advisory Committee meeting [PDF] 8/30/2000 65FR52775
Notice: Hearing on NDA withdrawal [PDF] 8/14/2001 66FR42665

Antihistamine Drug Products: Pediatric Use
Proposed Rule Date FR Citation
Notice: Advisory Committee Meeting [PDF] 8/16/2007 72FR46091
Notice of Public Hearing: Request for comments [PDF] 8/25/2008 73FR50033
Notice of Public Hearing: Correction [PDF] 9/2/2008 73FR51309