NDC 61577-4030

SOMBRA COOL THERAPY

Menthol

SOMBRA COOL THERAPY is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by Sombra Cosmetics Inc.. The primary component is Menthol.

Product ID61577-4030_616a9712-77f7-55f5-e053-2991aa0a46e9
NDC61577-4030
Product TypeHuman Otc Drug
Proprietary NameSOMBRA COOL THERAPY
Generic NameMenthol
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2017-10-20
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart348
Labeler NameSOMBRA COSMETICS INC.
Substance NameMENTHOL
Active Ingredient Strength0 g/g
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 61577-4030-1

3628.7 g in 1 BOTTLE, PUMP (61577-4030-1)
Marketing Start Date2017-10-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61577-4030-3 [61577403003]

SOMBRA COOL THERAPY GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-10-20
Inactivation Date2020-01-31
Reactivation Date2020-03-06

NDC 61577-4030-2 [61577403002]

SOMBRA COOL THERAPY GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-10-20
Inactivation Date2020-01-31
Reactivation Date2020-03-06

NDC 61577-4030-5 [61577403005]

SOMBRA COOL THERAPY GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-10-20
Inactivation Date2020-01-31
Reactivation Date2020-03-06

NDC 61577-4030-1 [61577403001]

SOMBRA COOL THERAPY GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-10-20
Inactivation Date2020-01-31
Reactivation Date2020-03-06

NDC 61577-4030-6 [61577403006]

SOMBRA COOL THERAPY GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-10-20
Inactivation Date2020-01-31
Reactivation Date2020-03-06

NDC 61577-4030-4 [61577403004]

SOMBRA COOL THERAPY GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-10-20
Inactivation Date2020-01-31
Reactivation Date2020-03-06

Drug Details

Active Ingredients

IngredientStrength
MENTHOL.06 g/g

OpenFDA Data

SPL SET ID:a2d403f7-aad0-4692-a36f-ee25a84a013f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 415976
  • NDC Crossover Matching brand name "SOMBRA COOL THERAPY" or generic name "Menthol"

    NDCBrand NameGeneric Name
    61577-3221SOMBRA COOL THERAPYSOMBRA COOL THERAPY
    61577-4030SOMBRA COOL THERAPYSOMBRA COOL THERAPY
    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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