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In this section: Historical Status of OTC Rulemakings

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:

Original Active Ingredients and Labeling
Nonmonograph Ingredients
Chlorcyclizine HCl, Doxylamine Succinate, and Triprolidine HCl
Combination Products
Common Cold
Diphenhydramine Warnings
Phenylpropanolamine (PPA)
Pediatric Use

**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

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