NDC 59316-206

Biofreeze Colorless Roll-On

Menthol

Biofreeze Colorless Roll-On is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by Performance Health Inc.. The primary component is Menthol.

Product ID59316-206_2c22ebec-9f44-0e8a-e054-00144ff8d46c
NDC59316-206
Product TypeHuman Otc Drug
Proprietary NameBiofreeze Colorless Roll-On
Generic NameMenthol
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2013-01-17
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart348
Labeler NamePerformance Health Inc.
Substance NameMENTHOL
Active Ingredient Strength40 mg/mL
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 59316-206-10

1 BOTTLE, WITH APPLICATOR in 1 CARTON (59316-206-10) > 89 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Start Date2013-01-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59316-206-10 [59316020610]

Biofreeze Colorless Roll-On GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-01-17

Drug Details

Active Ingredients

IngredientStrength
MENTHOL40 mg/mL

OpenFDA Data

SPL SET ID:a8d59d45-0e85-43d1-affd-bbe922c4acb1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 415974
  • 1111683
  • NDC Crossover Matching brand name "Biofreeze Colorless Roll-On" or generic name "Menthol"

    NDCBrand NameGeneric Name
    59316-206Biofreeze Colorless Roll-OnBiofreeze Colorless Roll-On
    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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