NDC 59316-116

Biofreeze Professional Colorless

Menthol, Unspecified Form

Biofreeze Professional Colorless 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 ID59316-116_5e5ada5b-b4eb-4184-867b-cae378b92216
NDC59316-116
Product TypeHuman Otc Drug
Proprietary NameBiofreeze Professional Colorless
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 59316-116-20

118 mL in 1 TUBE (59316-116-20)
Marketing Start Date2016-06-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59316-116-20 [59316011620]

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

NDC 59316-116-40 [59316011640]

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

NDC 59316-116-11 [59316011611]

Biofreeze Professional Colorless 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:4639201c-a67a-475f-8df6-3dc6225803ad
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1794892
  • 415975
  • NDC Crossover Matching brand name "Biofreeze Professional Colorless" or generic name "Menthol, Unspecified Form"

    NDCBrand NameGeneric Name
    59316-116Biofreeze Professional ColorlessBiofreeze Professional Colorless
    68071-1780Biofreeze Professional ColorlessBiofreeze Professional Colorless
    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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.