NDC 60630-091

DenTek Canker Cover

Menthol

DenTek Canker Cover is a Transmucosal Patch, Extended Release in the Human Otc Drug category. It is labeled and distributed by Dentek Oral Care, Inc.. The primary component is Menthol.

Product ID60630-091_26921ec2-016d-331e-e054-00144ff88e88
NDC60630-091
Product TypeHuman Otc Drug
Proprietary NameDenTek Canker Cover
Generic NameMenthol
Dosage FormPatch, Extended Release
Route of AdministrationTRANSMUCOSAL
Marketing Start Date2015-11-11
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart356
Labeler NameDenTek Oral Care, Inc.
Substance NameMENTHOL
Active Ingredient Strength3 mg/194.85mg
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 60630-091-04

1 DOSE PACK in 1 PACKET (60630-091-04) > 2.5 mg in 1 DOSE PACK (60630-091-01)
Marketing Start Date2015-12-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 60630-091-02 [60630009102]

DenTek Canker Cover PATCH, EXTENDED RELEASE
Marketing CategoryOTC MONOGRAPH NOT FINAL
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-11-11
Inactivation Date2020-01-31

NDC 60630-091-03 [60630009103]

DenTek Canker Cover PATCH, EXTENDED RELEASE
Marketing CategoryOTC MONOGRAPH NOT FINAL
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-11-11
Marketing End Date2017-08-31

NDC 60630-091-04 [60630009104]

DenTek Canker Cover PATCH, EXTENDED RELEASE
Marketing CategoryOTC monograph not final
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-12-01
Inactivation Date2020-01-31

NDC 60630-091-01 [60630009101]

DenTek Canker Cover PATCH, EXTENDED RELEASE
Marketing CategoryOTC MONOGRAPH NOT FINAL
Application Numberpart356
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-11-11

Drug Details

Active Ingredients

IngredientStrength
MENTHOL2.5 mg/194.85mg

OpenFDA Data

SPL SET ID:25de07eb-8232-6663-e054-00144ff88e88
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1725075
  • 1725069
  • NDC Crossover Matching brand name "DenTek Canker Cover" or generic name "Menthol"

    NDCBrand NameGeneric Name
    10564-0910Dentek Canker CoverDentek Canker Cover
    60630-091DenTek Canker CoverDenTek Canker Cover
    0363-1071Cherry Cough DropMenthol
    0363-1086Cherry Cough DropsMenthol
    0363-0150Cool n Heat Patch for Arm, Neck and LegMenthol
    0363-0152Cool n Heat Patch for BackMenthol
    0363-1072Honey Lemon Cough DropMenthol
    0363-1087Honey Lemon Cough DropMenthol
    0219-0203Humphreys Bendito Alcoholadomenthol
    0363-1070Menthol Cough Dropmenthol
    0363-1084Menthol Cough Dropmenthol
    0067-2067Mineral IceMenthol
    0316-0226Mineral IceMenthol
    0316-0290Mineral Ice Quick Dry FoamMenthol
    0363-0151Pain Relieving PatchMenthol
    0363-1077SF Honey Lemon Cough DropMenthol
    0363-1085SF Menthol Cough DropMenthol
    0363-0043Studio 35 Medicated BodyMenthol
    0363-0864Walgreens Cold Pain ReliefMENTHOL
    0363-0874Walgreens Cold Pain ReliefMENTHOL
    0363-0966Walgreens Sunburn ReliefMenthol

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