NDC 59316-102

Biofreeze

Menthol

Biofreeze 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 ID59316-102_3ce2d09b-f366-6a08-e054-00144ff8d46c
NDC59316-102
Product TypeHuman Otc Drug
Proprietary NameBiofreeze
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 Through2017-12-31

Packaging

NDC 59316-102-10

5 mL in 1 BOTTLE (59316-102-10)
Marketing Start Date2012-01-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59316-102-25 [59316010225]

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

NDC 59316-102-50 [59316010250]

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

NDC 59316-102-20 [59316010220]

BIOFREEZE GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2012-01-03

NDC 59316-102-80 [59316010280]

BIOFREEZE GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-11-02

NDC 59316-102-30 [59316010230]

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

NDC 59316-102-98 [59316010298]

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

NDC 59316-102-15 [59316010215]

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

NDC 59316-102-16 [59316010216]

BIOFREEZE GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-09-19
Marketing End Date2020-02-26

NDC 59316-102-11 [59316010211]

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

NDC 59316-102-12 [59316010212]

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

NDC 59316-102-40 [59316010240]

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

NDC 59316-102-10 [59316010210]

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

NDC 59316-102-28 [59316010228]

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

Drug Details

Active Ingredients

IngredientStrength
MENTHOL40 mg/mL

OpenFDA Data

SPL SET ID:83d5c2f2-2413-4d28-83b2-0808d0917b4d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 415974
  • 1111683
  • NDC Crossover Matching brand name "Biofreeze" or generic name "Menthol"

    NDCBrand NameGeneric Name
    68788-6457BiofreezeBiofreeze
    59316-102BIOFREEZEBIOFREEZE
    59316-993BiofreezeBiofreeze
    59316-101BiofreezeBiofreeze
    59316-104BiofreezeBiofreeze
    59316-114BiofreezeBiofreeze
    59316-869BiofreezeBiofreeze
    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

    Trademark Results [Biofreeze]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    BIOFREEZE
    BIOFREEZE
    98087578 not registered Live/Pending
    Reckitt Health Pain (US) LLC
    2023-07-17
    BIOFREEZE
    BIOFREEZE
    79064496 3689666 Dead/Cancelled
    Liebherr-International AG
    2008-12-19
    BIOFREEZE
    BIOFREEZE
    74316856 1774041 Live/Registered
    HYGENIC INTANGIBLE PROPERTY HOLDING CO.
    1992-09-24

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