NDC 57329-010

THERAFREEZE

Menthol

THERAFREEZE is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by Astrum Pharma. The primary component is Menthol.

Product ID57329-010_b9cbc519-8615-43a5-939e-0e2763e2d5ee
NDC57329-010
Product TypeHuman Otc Drug
Proprietary NameTHERAFREEZE
Generic NameMenthol
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2013-08-08
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameAstrum Pharma
Substance NameMENTHOL
Active Ingredient Strength60 mg/mL
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 57329-010-01

473 mL in 1 TUBE (57329-010-01)
Marketing Start Date2013-08-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 57329-010-01 [57329001001]

THERAFREEZE GEL
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-08-08
Inactivation Date2019-11-27

Drug Details

Active Ingredients

IngredientStrength
MENTHOL60 mg/mL

OpenFDA Data

SPL SET ID:7660635b-db41-4bfa-95f2-ecb1837e4931
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1439987
  • 415976
  • UPC Code
  • 0852664334126
  • NDC Crossover Matching brand name "THERAFREEZE" or generic name "Menthol"

    NDCBrand NameGeneric Name
    57329-010THERAFREEZETHERAFREEZE
    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 [THERAFREEZE]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    THERAFREEZE
    THERAFREEZE
    77296160 not registered Dead/Abandoned
    PERFORMANCE TOUCH, LLC
    2007-10-04

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