NDC 59316-205

Biofreeze Roll-On

Menthol

Biofreeze Roll-On 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 ID59316-205_1e1d7296-5e01-485b-82e5-e1daa9f2b51a
NDC59316-205
Product TypeHuman Otc Drug
Proprietary NameBiofreeze Roll-On
Generic NameMenthol
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2013-01-17
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart348
Labeler NameRB Health (US) LLC
Substance NameMENTHOL, UNSPECIFIED FORM
Active Ingredient Strength40 mg/mL
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 59316-205-10

89 mL in 1 BOTTLE (59316-205-10)
Marketing Start Date2013-01-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59316-205-14 [59316020514]

Biofreeze Roll-On GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-01-17

NDC 59316-205-10 [59316020510]

Biofreeze Roll-On GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-01-17

Drug Details

Active Ingredients

IngredientStrength
MENTHOL40 mg/mL

OpenFDA Data

SPL SET ID:ebbbe9cb-b1ce-4dac-9fca-f54a2470c4fb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 415974
  • 1111683

    • NDC Crossover Matching brand name "Biofreeze Roll-On" or generic name "Menthol"

    NDCBrand NameGeneric Name
    70518-0068Biofreeze Roll-OnBiofreeze Roll-On
    70518-0485Biofreeze Roll-OnBiofreeze Roll-On
    59316-205Biofreeze Roll-OnBiofreeze Roll-On
    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
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