NDC 59316-119

Biofreeze Professional

Menthol, Unspecified Form

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

Product ID59316-119_66b1314e-1e1f-d308-e053-2a91aa0a2cb0
NDC59316-119
Product TypeHuman Otc Drug
Proprietary NameBiofreeze Professional
Generic NameMenthol, Unspecified Form
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2016-06-03
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart348
Labeler NamePerformance Health, LLC
Substance NameMENTHOL, UNSPECIFIED FORM
Active Ingredient Strength50 mg/mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 59316-119-20

118 mL in 1 TUBE, WITH APPLICATOR (59316-119-20)
Marketing Start Date2016-06-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59316-119-20 [59316011920]

Biofreeze Professional GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-06-03
Marketing End Date2020-12-31

Drug Details

Active Ingredients

IngredientStrength
MENTHOL, UNSPECIFIED FORM50 mg/mL

OpenFDA Data

SPL SET ID:c28aeff9-3a77-4a51-80f0-775bd7543e06
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1794892
  • 415975
  • NDC Crossover Matching brand name "Biofreeze Professional" or generic name "Menthol, Unspecified Form"

    NDCBrand NameGeneric Name
    68071-4325Biofreeze ProfessionalBiofreeze Professional
    68071-4589Biofreeze ProfessionalBiofreeze Professional
    59316-115Biofreeze ProfessionalBiofreeze Professional
    59316-120Biofreeze ProfessionalBiofreeze Professional
    59316-119Biofreeze ProfessionalBiofreeze Professional
    51068-507ActivOn Ultra Strength ArthritisMenthol, Unspecified Form
    58980-615ARCTIC RELIEFMENTHOL, UNSPECIFIED FORM
    58980-618ARCTIC RELIEF PAIN RELIEVINGMENTHOL, UNSPECIFIED FORM
    58980-617ARCTIC RELIEF ROLL ONMENTHOL, UNSPECIFIED FORM
    59316-005Biofreeze Overnight ReliefMenthol, Unspecified Form
    10157-3101Blistex Odor Eaters Medicated FootMENTHOL, UNSPECIFIED FORM
    55910-883DG Health Cold n Hot Pain Relievingmenthol, unspecified form
    55910-884DG Health Cold Zone Pain RelievingMENTHOL, UNSPECIFIED FORM
    50066-410Dragon Pain ReliefMENTHOL, UNSPECIFIED FORM
    55882-6102HelloMenthol, Unspecified Form
    55882-3499Hello Naturally Fresh AntisepticMENTHOL, UNSPECIFIED FORM
    41250-350Meijer Maximum Strength Pain Relievingmenthol, unspecified form
    50382-016Muscle and JointMenthol, Unspecified Form
    52000-072Muscle Rub Pain Reliever GelMENTHOL, UNSPECIFIED FORM
    0536-1061Rugby Ice BlueMENTHOL, UNSPECIFIED FORM
    36800-894TopCare Maximum Strength Pain RelievingMENTHOL, UNSPECIFIED FORM
    36800-290TopCare Pain Relieving Roll-OnMENTHOL, UNSPECIFIED FORM
    0363-4837Walgreen Cool n Heat Maximum Strength Pain RelievingMENTHOL, UNSPECIFIED FORM
    0363-6330Walgreens Ice Blue Pain RelievingMENTHOL, UNSPECIFIED FORM
    54273-002ZIMS MAX FREEZEMENTHOL, UNSPECIFIED FORM
    54273-003ZIMS MAX FREEZEMENTHOL, UNSPECIFIED FORM
    54273-004ZIMS MAX FREEZEMENTHOL, UNSPECIFIED FORM
    54273-006ZIMS MAX FREEZEMENTHOL, UNSPECIFIED FORM
    54273-007ZIMS MAX FREEZEMENTHOL, UNSPECIFIED FORM
    54273-009ZIMS MAX FREEZEMENTHOL, UNSPECIFIED FORM

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