NDC 61577-4050

SORE NO MORE COOL THERAPY

Menthol

SORE NO MORE 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 ID61577-4050_6169bf1d-4911-728d-e053-2991aa0ae410
NDC61577-4050
Product TypeHuman Otc Drug
Proprietary NameSORE NO MORE COOL THERAPY
Generic NameMenthol
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2017-06-05
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 61577-4050-2

907.2 g in 1 BOTTLE, PUMP (61577-4050-2)
Marketing Start Date2017-06-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61577-4050-3 [61577405003]

SORE NO MORE COOL THERAPY GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-06-05
Inactivation Date2020-01-31
Reactivation Date2020-03-06

NDC 61577-4050-5 [61577405005]

SORE NO MORE COOL THERAPY GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-06-05
Inactivation Date2020-01-31
Reactivation Date2020-03-06

NDC 61577-4050-2 [61577405002]

SORE NO MORE COOL THERAPY GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-06-05
Inactivation Date2020-01-31
Reactivation Date2020-03-06

NDC 61577-4050-4 [61577405004]

SORE NO MORE COOL THERAPY GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-06-05
Inactivation Date2020-01-31
Reactivation Date2020-03-06

Drug Details

Active Ingredients

IngredientStrength
MENTHOL.06 g/g

OpenFDA Data

SPL SET ID:7203719d-ffeb-4490-b77d-690282a09926
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 415976
  • NDC Crossover Matching brand name "SORE NO MORE COOL THERAPY" or generic name "Menthol"

    NDCBrand NameGeneric Name
    61577-3235SORE NO MORE COOL THERAPYSORE NO MORE COOL THERAPY
    61577-4050SORE NO MORE COOL THERAPYSORE NO MORE 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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