NDC 59316-111

PERFORM COOL and SOOTHING PAIN RELIEVING

Menthol

PERFORM COOL and SOOTHING PAIN RELIEVING 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 ID59316-111_47f44c88-ca8b-42e1-e054-00144ff8d46c
NDC59316-111
Product TypeHuman Otc Drug
Proprietary NamePERFORM COOL and SOOTHING PAIN RELIEVING
Generic NameMenthol
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2015-05-18
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 59316-111-10

3 mL in 1 TUBE (59316-111-10)
Marketing Start Date2015-05-18
Marketing End Date2023-12-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59316-111-10 [59316011110]

PERFORM COOL and SOOTHING PAIN RELIEVING GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-05-18
Marketing End Date2023-12-31

NDC 59316-111-11 [59316011111]

PERFORM COOL and SOOTHING PAIN RELIEVING GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-05-18
Marketing End Date2023-12-31

NDC 59316-111-20 [59316011120]

PERFORM COOL and SOOTHING PAIN RELIEVING GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2015-05-18

Drug Details

Active Ingredients

IngredientStrength
MENTHOL35 mg/mL

OpenFDA Data

SPL SET ID:ef158f63-2d75-47a3-b94a-2d821d511863
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 808955
  • NDC Crossover Matching brand name "PERFORM COOL and SOOTHING PAIN RELIEVING" or generic name "Menthol"

    NDCBrand NameGeneric Name
    59316-111PERFORM COOL and SOOTHING PAIN RELIEVINGPERFORM COOL and SOOTHING PAIN RELIEVING
    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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