NDC 59316-103

Biofreeze Colorless

Menthol

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

Product ID59316-103_3ce2d09b-f377-6a08-e054-00144ff8d46c
NDC59316-103
Product TypeHuman Otc Drug
Proprietary NameBiofreeze Colorless
Generic NameMenthol
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2016-09-19
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart348
Labeler NamePerformance Health LLC
Substance NameMENTHOL
Active Ingredient Strength40 mg/mL
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 59316-103-11

3 mL in 1 BOTTLE (59316-103-11)
Marketing Start Date2012-01-03
Marketing End Date2021-12-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59316-103-10 [59316010310]

Biofreeze Colorless GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-01-03
Marketing End Date2014-12-31

NDC 59316-103-28 [59316010328]

Biofreeze Colorless GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-09-19
Marketing End Date2019-12-31

NDC 59316-103-20 [59316010320]

Biofreeze Colorless GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-01-03

NDC 59316-103-11 [59316010311]

Biofreeze Colorless GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-01-03
Marketing End Date2021-12-31

NDC 59316-103-12 [59316010312]

Biofreeze Colorless GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2016-09-19

NDC 59316-103-15 [59316010315]

Biofreeze Colorless GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-01-03
Marketing End Date2018-12-31

NDC 59316-103-40 [59316010340]

Biofreeze Colorless GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-01-03

Drug Details

Active Ingredients

IngredientStrength
MENTHOL40 mg/mL

OpenFDA Data

SPL SET ID:27dbe7b7-8f56-41e6-93a0-4581d2dfb451
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 415974
  • 1111683
  • NDC Crossover Matching brand name "Biofreeze Colorless" or generic name "Menthol"

    NDCBrand NameGeneric Name
    59316-103Biofreeze ColorlessBiofreeze Colorless
    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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