Rulemaking History for OTC Antitussive Drug Products
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Date	Federal Register Citation	Description
9/9/1976	41FR38312	Advance Notice of Proposed Rulemaking
11/30/1976	41FR52537	Notice: Hearing on unapproved benylin NDA
10/28/1977	42FR56756	Proposed Rule: Clarifies dosage for phenylpropanolamine (PPA)
8/31/1979	44FR51512	Final Decision: Benylin
10/2/1979	44FR56744	Correction: 8/31/1979 Final Decision
3/21/1980	45FR18400	Reopening of Administrative Record
9/26/1980	45FR63874	Reopening of Administrative Record: Camphor-containing products
4/29/1983	48FR19470	Notice: Advisory Committee meeting
5/6/1983	48FR20502	Notice: Re-publication of 4/29/1983 Notice
10/19/1983	48FR48576	Tentative Final Monograph
11/16/1983	48FR52079	Correction: Tentative Final Monograph
8/12/1987	52FR30042	Final Monograph
9/9/1987	52FR34047	Correction: Final Monograph
9/22/1987	52FR35610	Correction: Final Monograph
8/12/1988	53FR30522	Proposed Rule: Combination products
9/15/1988	53FR35808	Technical Amendment: Clarifies age range for children's dosage
11/14/1988	53FR45774	Clarification: Promethazine HCl combinations (8/12/1988 Proposed Rule)
7/6/1989	54FR28442	Proposed Rule: Exempts menthol lozenges from "accidental overdose" warning
9/5/1989	54FR36762	Notice: Prohibits interim marketing of promethazine HCl combinations
10/2/1989	54FR40412	Proposed Rule: Allows and defines "lozenge" as solid dose
11/28/1989	54FR48914	Reopening of Administrative Record: Promethazine HCl combinations
1/4/1990	55FR310	Correction: 11/28/1989 Reopening of Administrative Record
1/24/1990	55FR2387	Extension of Comment Period: 11/28/1989 Reopening of Administrative Record
7/6/1990	55FR27806	Final Rule: Exempts menthol lozenges from "accidental overdose" warning
10/3/1990	55FR40381	Final Rule: Allows and defines "lozenge" as solid dose
6/19/1992	57FR27666	Proposed Rule: Requires monoamine oxidase inhibitor (MAOI) warning for dextromethorphan
8/6/1992	57FR34735	Extension of Comment Period: 6/19/1992 Proposed Rule
12/9/1992	57FR58378	Proposed Rule: Adds diphenhydramine HCl and citrate as GRASE ingredients
10/20/1993	58FR54232	Final Rule: : Requires monoamine oxidase inhibitor (MAOI) warning for dextromethorphan
6/3/1994	59FR29172	Final Rule: Adds diphenhydramine HCl and citrate as GRASE ingredients
7/15/1994	59FR36051	Correction: 6/3/1994 Final Rule
2/23/1995	60FR10286 [HTML]	Proposed Rule: Classifies diphenhydramine combinations as GRASEs
4/9/1996	61FR15700 [HTML]	Final Rule: Allows interim marketing of diphenhydramine combinations
8/29/1997	62FR45767 [HTML]	Proposed Rule: Requires warning on all diphenhydramine products
7/20/1998	63FR38762 [HTML]	Proposed Rule: Revises warning and directions for topical/inhalant camphor and menthol products
8/1/2000	65FR46864 [HTML]	Final Rule: Revises warning and directions for topical/inhalant camphor and menthol products
8/30/2000	65FR52775 [HTML]	Notice: Advisory Committee meeting on phenylpropanolamine (PPA)
8/14/2001	66FR42665 [HTML]	Notice: Hearing on phenylpropanolamine (PPA) NDA withdrawal
12/6/2002	67FR72555 [HTML]	Final Rule: Requires warning on all diphenhydramine products
12/23/2002	67FR78158 [HTML]	Final Rule: Combination products
3/19/2007	72FR12730 [HTML]	Technical Amendment: Correction (12/23/2002 Final Rule)
8/16/2007	72FR46091 [HTML]	Notice: Advisory Committee Meeting
10/1/2007	72R55784 [HTML]	Amendment of Notice: Advisory Committee Meeting
11/30/2007	72FR67639 [HTML]	Technical Amendment: Removes carbetapentane citrate from 21CFR310.201(a)(20)
8/25/2008	73FR50033	Notice of Public Hearing; Request for comments
9/1/2008	73FR51309	Notice of Public Hearing: Correction

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Date updated: September 5, 2008

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