NDC 59316-101

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 ID59316-101_606234a7-6409-61f2-e053-2991aa0ae3d1
NDC59316-101
Product TypeHuman Otc Drug
Proprietary NameBiofreeze
Generic NameMenthol
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2016-08-25
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart348
Labeler NamePerformance Health LLC.
Substance NameMENTHOL
Active Ingredient Strength35 mg/mL
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 59316-101-10

5 mL in 1 PACKET (59316-101-10)
Marketing Start Date2016-08-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59316-101-20 [59316010120]

Biofreeze GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2009-12-30

NDC 59316-101-15 [59316010115]

Biofreeze GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-08-25

NDC 59316-101-30 [59316010130]

Biofreeze GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2009-12-30

NDC 59316-101-12 [59316010112]

Biofreeze GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-08-25

NDC 59316-101-00 [59316010100]

Biofreeze GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2010-06-30
Marketing End Date2010-11-03

NDC 59316-101-11 [59316010111]

Biofreeze GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-08-25

NDC 59316-101-21 [59316010121]

Biofreeze GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2009-12-30
Marketing End Date2018-12-31

NDC 59316-101-25 [59316010125]

Biofreeze GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2009-12-01

NDC 59316-101-40 [59316010140]

Biofreeze GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2009-12-30

NDC 59316-101-10 [59316010110]

Biofreeze GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-08-25

NDC 59316-101-13 [59316010113]

Biofreeze GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-08-25

NDC 59316-101-50 [59316010150]

Biofreeze GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2009-12-30

Drug Details

Active Ingredients

IngredientStrength
MENTHOL35 mg/mL

OpenFDA Data

SPL SET ID:684faf63-5e44-4471-8384-e8fa7c0d842a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 808955
  • 1043451
  • UPC Code
  • 0731124100009
  • 0731124100115
  • 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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