Rulemaking History for OTC Oral Healthcare Drug Products

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Rulemaking History for OTC Oral Healthcare Drug Products
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Pending Final Monograph (21 CFR part 356):
Oral Health Care Drug Products for Over-the-Counter Human Use

OTC Oral Healthcare Drug Products found on this page:

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**Oral Healthcare Drug Products: Anesthetic, Astringent, Antimicrobial, Debriding, Demulcent, Expectorant, Decongestant**
Advance Notice Of Proposed Rulemaking	Date	FR Citation
Advance Notice of Proposed Rulemaking	5/25/1982	47FR22760
Extension of Comment Period	7/30/1982	47FR32953
Correction	10/15/1982	47FR46117
Extension of Comment Period	12/28/1982	47FR57738
Proposed Rule	Date	FR Citation
Tentative Final Monograph	1/27/1988	53FR2436
Correction	3/17/1988	53FR8845
Proposed Rule: Exempts menthol lozenges from accidental overdose warning	5/13/1992	57FR20434
Correction	6/25/1992	57FR28555
Correction	7/9/1992	57FR30534
Correction	7/27/1992	57FR33237

**Oral Healthcare Drug Products: Antigingivitis/Antiplaque**
Advance Notice Of Proposed Rulemaking	Date	FR Citation
Request for Data	9/19/1990	55FR38560
Correction	10/9/1990	55FR41170
Extension of Comment Period	3/8/1991	56FR9915
Notice: Advisory Committee meeting	9/19/1994	59FR47880
Advance Notice of Proposed Rulemaking	5/29/2003	68FR32232
Extension of Comment Period	8/25/2003	68FR50991
Correction	10/6/2003	68FR57642
Notice: Availability of Draft Guidance on development and evaluation of these drug products Guidance	6/28/2005	70FR37102
Extension of Comment Period: Gingivitis claims	8/24/2005	70FR49660
Request for Data: Triclosan time and extent application	7/6/2004	69FR40640

**Oral Healthcare Drug Products: Oral Antiseptic**
Advance Notice Of Proposed Rulemaking	Date	FR Citation
Advance Notice of Proposed Rulemaking	5/25/1982	47FR22760
Extension of Comment Period	7/30/1982	47FR32953
Proposed Rule	Date	FR Citation
Proposed Rule	2/9/1994	59FR6084
Correction	3/14/1994	59FR11836

**Oral Healthcare Drug Products: Toothache Relief, Tooth Desensitizer, Analgesic, Protectant**
Advance Notice Of Proposed Rulemaking	Date	FR Citation
Advance Notice of Proposed Rulemaking	5/25/1982	47FR22712
Proposed Rule	Date	FR Citation
Proposed Rule	9/24/1991	56FR48302
Correction	12/19/1991	56FR65930

**Oral Healthcare Drug Products: Toothache Relief, Tooth Desensitizer, Analgesic, Protectant**
Proposed Rule	Date	FR Citation
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph	5/16/1990	55FR20434
Correction	6/7/1990	55FR23235
Final Rule	Date	FR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph	11/7/1990	55FR46914
Correction	12/3/1990	55FR49973
Technical Amendment: Corrects an ingredient name	1/30/1992	57FR3526

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