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U.S. Department of Health and Human Services

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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 Rulemaking [PDF]5/25/198247FR22760
    Extension of Comment Period [PDF]7/30/198247FR32953
    Correction [PDF]10/15/198247FR46117
    Extension of Comment Period [PDF]12/28/198247FR57738
Proposed RuleDateFR Citation
Tentative Final Monograph [PDF]1/27/198853FR2436
    Correction [PDF]3/17/198853FR8845
Proposed Rule: Exempts menthol lozenges from accidental overdose warning [PDF]5/13/199257FR20434
    Correction [PDF]6/25/199257FR28555
    Correction [PDF]7/9/199257FR30534
    Correction [PDF]7/27/199257FR33237

Oral Healthcare Drug Products: Antigingivitis/Antiplaque
Advance Notice Of Proposed RulemakingDateFR Citation
Request for Data [PDF]9/19/199055FR38560
     Correction [PDF]10/9/199055FR41170
     Extension of Comment Period [PDF]3/8/199156FR9915
Notice:  Advisory Committee meeting [PDF]9/19/199459FR47880
Advance Notice of Proposed Rulemaking [PDF]5/29/200368FR32232
     Extension of Comment Period [PDF]8/25/200368FR50991
     Correction [PDF]10/6/200368FR57642
  Notice: Availability of Draft Guidance on development and evaluation of these drug products [PDF]
    Guidance [PDF]
6/28/200570FR37102
     Extension of Comment Period: Gingivitis claims [PDF]8/24/200570FR49660
Request for Data: Triclosan time and extent application [PDF]

 7/6/2004

69FR40640

Oral Healthcare Drug Products: Oral Antiseptic
Advance Notice Of Proposed RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking [PDF]5/25/198247FR22760
     Extension of Comment Period [PDF]7/30/198247FR32953
Proposed RuleDateFR Citation
Proposed Rule  [PDF]2/9/199459FR6084
    Correction [PDF]3/14/199459FR11836

Oral Healthcare Drug Products: Toothache Relief, Tooth Desensitizer, Analgesic, Protectant
Advance Notice Of Proposed RulemakingDateFR Citation
Advance Notice of Proposed Rulemaking [PDF]5/25/198247FR22712
Proposed RuleDateFR Citation
Proposed Rule [PDF]9/24/199156FR48302
     Correction [PDF]12/19/199156FR65930

Oral Healthcare Drug Products: Nonmonograph Ingredients
Proposed RuleDateFR Citation
Proposed Rule: Classifies category II and III ingredients without data as nonmonograph [PDF]5/16/199055FR20434
    Correction [PDF]6/7/199055FR23235
Final RuleDateFR Citation
Final Rule: Classifies category II and III ingredients without data as nonmonograph [PDF]11/7/199055FR46914
    Correction [PDF]12/3/199055FR49973
    Technical Amendment: Corrects an ingredient name [PDF]1/30/199257FR3526