Rulemaking History for OTC Oral Healthcare Drug Products
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Date	Federal Register Citation	Description
5/25/1982	47FR22712	Advance Notice of Proposed Rulemaking: Toothache relief, tooth desensitizer, analgesic, protectant
5/25/1982	47FR22760	Advance Notice of Proposed Rulemaking
7/30/1982	47FR32953	Extension of Comment Period: Advance Notice of Proposed Rulemaking
10/15/1982	47FR46117	Correction: Advance Notice of Proposed Rulemaking
12/28/1982	47FR57738	Extension of Comment Period: Advance Notice of Proposed Rulemaking
1/27/1988	53FR2436	Tentative Final Monograph
3/17/1988	53FR8845	Correction: Tentative Final Monograph
5/16/1990	55FR20434	Proposed Rule: Classifies category II and III ingredients without data as nonmonograph
6/7/1990	55FR23235	Correction: 5/16/1990 Proposed Rule
9/19/1990	55FR38560	Request for Data: Antigingivitis/antiplaque
10/9/1990	55FR41170	Correction: 9/19/1990 Request for Data
11/7/1990	55FR46914	Final Rule: Classifies category II and III ingredients without data as nonmonograph
12/3/1990	55FR49973	Correction: 11/7/1990 Final Rule
3/8/1991	56FR9915	Extension of Comment Period: 9/19/1990 Request for Data
9/24/1991	56FR48302	Proposed Rule: Toothache relief, tooth desensitizer, analgesic, protectant
12/19/1991	56FR65930	Correction: 9/24/1991 Proposed Rule
1/30/1992	57FR3526	Technical Amendment: Correct an ingredient name (11/7/1990 Final Rule)
5/13/1992	57FR20434	Proposed Rule: Exempts menthol lozenges from accidental overdose warning
6/25/1992	57FR28555	Correction: 5/13/1992 Proposed Rule
7/9/1992	57FR30534	Correction: 5/13/1992 Proposed Rule
7/27/1992	57FR33237	Correction: 5/13/1992 Proposed Rule
2/9/1994	59FR6084	Proposed Rule: Oral antiseptic
3/14/1994	59FR11836	Correction: 2/9/1994 Proposed Rule
9/19/1994	59FR47880	Notice:  Advisory Committee meeting on antigingivitis/antiplaque
5/29/2003	68FR32232 [HTML]	Advance Notice of Proposed Rulemaking: Antigingivitis/antiplaque
8/25/2003	68FR50991 [HTML]	Extension of Comment Period: 5/29/2003 Advance Notice of Proposed Rulemaking
10/6/2003	68FR57642 [HTML]	Correction: 5/29/2003 Advance Notice of Proposed Rulemaking
7/6/2004	70FR37102 [HTML]	Request for Data: Triclosan (Time and Extent Application) for antigingivitis/antiplaque
6/28/2005	70FR49660 [HTML]	Notice: Availability of draft guidance on development and evaluation of these drug products
8/24/2005	70FR49660 [HTML]	Extension of Comment Period: Gingivitis claims (5/29/2003 Advance Notice of Proposed Rulemaking)

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Date updated: December 28, 2006; Last updated: April 12, 2007

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