NDC 59316-115

Biofreeze Professional

Menthol, Unspecified Form

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

Product ID59316-115_47490d29-db74-4ad7-86d0-9dba5090c781
NDC59316-115
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 NameRB Health (US) LLC
Substance NameMENTHOL, UNSPECIFIED FORM
Active Ingredient Strength50 mg/mL
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 59316-115-11

3 mL in 1 PACKET (59316-115-11)
Marketing Start Date2016-06-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59316-115-20 [59316011520]

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

NDC 59316-115-11 [59316011511]

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

NDC 59316-115-82 [59316011582]

Biofreeze Professional GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-01-05

NDC 59316-115-40 [59316011540]

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

NDC 59316-115-50 [59316011550]

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

NDC 59316-115-30 [59316011530]

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

Drug Details

Active Ingredients

IngredientStrength
MENTHOL, UNSPECIFIED FORM50 mg/mL

OpenFDA Data

SPL SET ID:6bef9ccb-7a5a-4c67-b1bc-a92b167312da
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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