Drugs

Rulemaking History for OTC Oral Healthcare Drug Products

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:

Oral Healthcare Drug Products: Anesthetic, Astringent, Antimicrobial, Debriding, Demulcent, Expectorant, Decongestant

Advance Notice Of Proposed RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking5/25/198247FR22760
    Extension of Comment Period7/30/198247FR32953
    Correction10/15/198247FR46117
    Extension of Comment Period12/28/198247FR57738
Proposed RuleDateFR Citation
Tentative Final Monograph1/27/198853FR2436
    Correction3/17/198853FR8845
Proposed Rule: Exempts menthol lozenges from accidental overdose warning5/13/199257FR20434
    Correction6/25/199257FR28555
    Correction7/9/199257FR30534
    Correction7/27/199257FR33237

Oral Healthcare Drug Products: Antigingivitis/Antiplaque

Advance Notice Of Proposed RulemakingDateFR Citation
Request for Data9/19/199055FR38560
     Correction10/9/199055FR41170
     Extension of Comment Period3/8/199156FR9915
Notice:  Advisory Committee meeting9/19/199459FR47880
Advance Notice of Proposed Rulemaking5/29/200368FR32232
     Extension of Comment Period8/25/200368FR50991
     Correction10/6/200368FR57642
  Notice: Availability of Draft Guidance on development and evaluation of these drug products
    Guidance
6/28/200570FR37102
     Extension of Comment Period: Gingivitis claims8/24/200570FR49660
Request for Data: Triclosan time and extent application 

 7/6/2004

69FR40640

Oral Healthcare Drug Products: Oral Antiseptic

Advance Notice Of Proposed RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking5/25/198247FR22760
     Extension of Comment Period7/30/198247FR32953
Proposed RuleDateFR Citation
Proposed Rule  2/9/199459FR6084
    Correction3/14/199459FR11836
 Oral Healthcare Drug Products: Toothache Relief, Tooth Desensitizer, Analgesic, Protectant
Advance Notice Of Proposed RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking5/25/198247FR22712
Proposed RuleDateFR Citation
Proposed Rule9/24/199156FR48302
     Correction12/19/199156FR65930

Oral Healthcare Drug Products: Nonmonograph Ingredients 

Proposed RuleDateFR Citation
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph5/16/199055FR20434
    Correction6/7/199055FR23235
Final RuleDateFR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph11/7/199055FR46914
    Correction12/3/199055FR49973
    Technical Amendment: Corrects an ingredient name1/30/199257FR3526

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