Rulemaking History for OTC Antitussive Drug Products

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Rulemaking History for OTC Antitussive Drug Products
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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:

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**Antitussive Drug Products: Original Active Ingredients and Labeling**
Advance Notice Of Proposed Rulemaking	Date	FR Citation
Advance Notice of Proposed Rulemaking	9/9/1976	41FR38312
Reopening of Administrative Record	3/21/1980	45FR18400
Reopening of Administrative Record: Camphor-containing products	9/26/1980	45FR63874
Notice: Advisory Committee meeting	4/29/1983	48FR19470
Notice: Republication of 4/29/1983 notice	5/6/1983	48FR20502
Proposed Rule	Date	FR Citation
Tentative Final Monograph	10/19/1983	48FR48576
Correction	11/16/1983	48FR52079
Final Rule	Date	FR Citation
Final Monograph	8/12/1987	52FR30042
Correction	9/9/1987	52FR34047
Correction	9/22/1987	52FR35610
Technical Amendment: Clarifies age range for children's dosage	9/15/1988	53FR35808
Technical Amendment: Removes carbetapentane citrate from 21CFR310.201(a)(20)	11/30/2007	72FR67639

**Antitussive Drug Products: Benylin**
Proposed Rule	Date	FR Citation
Notice: Hearing on unapproved NDA	11/30/1976	41FR52537
Final Rule	Date	FR Citation
Final Decision	8/31/1979	44FR51512
Correction	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	7/20/1998	63FR38762
Final Rule	Date	FR Citation
Final Rule	8/1/2000	65FR46864

**Antitussive Drug Products: Combination Products**
Proposed Rule	Date	FR Citation
Proposed Rule	8/12/1988	53FR30522
Clarification: Promethazine HCl combinations	11/14/1988	53FR45774
Notice: Bans interim marketing of promethazine HCl combinations	9/5/1989	54FR36762
Reopening of Administrative Record: Promethazine HCl combinations	11/28/1989	54FR48914
Correction	1/4/1990	55FR310
Extension of Comment Period	1/24/1990	55FR2387
Final Rule	Date	FR Citation
Final Rule	12/23/2002	67FR78158
Technical Amendment: Correction	3/19/2007	72FR12730

**Antitussive Drug Products: Dextromethorphan**
Proposed Rule	Date	FR Citation
Proposed Rule: Monoamine oxidase inhibitor (MAOI) warning	6/19/1992	57FR27666
Extension of Comment Period	8/6/1992	57FR34735
Final Rule	Date	FR Citation
Final Rule	10/20/1993	58FR54232

**Antitussive Drug Products: Diphenhydramine HCl and Citrate**
Proposed Rule	Date	FR Citation
Proposed Rule: Adds diphenhydramine HCl & diphenhydramine citrate as GRASE ingredients	12/9/1992	57FR58378
Proposed Rule: Classifies diphenhydramine combinations as GRASE or nonmonograph	2/23/1995	60FR10286
Proposed Rule: Requires warnings on all diphenhydramine products	8/29/1997	62FR45767
Final Rule	Date	FR Citation
Final Rule: Adds diphenhydramine HCl & diphenhydramine citrate as GRASE ingredients	6/3/1994	59FR29172
Correction	7/15/1994	59FR36051
Final Rule: Allows interim marketing of combinations	4/9/1996	61FR15700
Final Rule: Requires warnings on all diphenhydramine products	12/6/2002	67FR72555

**Antitussive Drug Products: Menthol Lozenge**
Proposed Rule	Date	FR Citation
Proposed Rule: Exempts "accidental overdose" warning	7/6/1989	54FR28442
Proposed Rule: Allows and defines "lozenge" as solid dose	10/2/1989	54FR40412
Final Rule	Date	FR Citation
Final Rule: Exempts "accidental overdose" warning	7/6/1990	55FR27806
Final Rule: Allows and defines "lozenge" as solid dose	10/3/1990	55FR40381

**Antitussive Drug Products: Pediatric Use**
Proposed Rule	Date	FR Citation
Notice: Advisory Committee Meeting	8/16/2007	72FR46091
Amendment of Notice: Advisory Committee Meeting	10/1/2007	72FR55784
Notice of Public Hearing; Request for comments	8/25/2008	73FR50033
Notice of Public Hearing: Correction	9/1/2008	73FR51309

**Antitussive Drug Products: Phenylpropanolamine (PPA)**
Proposed Rule	Date	FR Citation
Proposed Rule: Clarifies dosage	10/28/1977	42FR56756
Notice: Advisory Committee meeting	8/30/2000	65FR52775
Notice: Hearing on NDA withdrawal	8/14/2001	66FR42665

Date created: December 28, 2006; Last updated: September 5, 2008