NDC 61577-3242

RE-LEVE

Menthol

RE-LEVE 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 ID61577-3242_7dc81bbd-1419-1c3f-e053-2a91aa0a6d5c
NDC61577-3242
Product TypeHuman Otc Drug
Proprietary NameRE-LEVE
Generic NameMenthol
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2016-10-05
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart348
Labeler NameSOMBRA COSMETICS INC.
Substance NameMENTHOL
Active Ingredient Strength0 g/g
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 61577-3242-4

113.6 g in 1 JAR (61577-3242-4)
Marketing Start Date2016-10-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61577-3242-4 [61577324204]

RE-LEVE GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-10-05
Inactivation Date2020-01-31
Reactivation Date2020-03-06

NDC 61577-3242-5 [61577324205]

RE-LEVE GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-10-05
Inactivation Date2020-01-31
Reactivation Date2020-03-06

Drug Details

Active Ingredients

IngredientStrength
MENTHOL.06 g/g

OpenFDA Data

SPL SET ID:b4b39d79-0439-41e7-adca-e5ccb8f44e40
Manufacturer
UNII
UPC Code
  • 0040232495960

    • NDC Crossover Matching brand name "RE-LEVE" or generic name "Menthol"

    NDCBrand NameGeneric Name
    61577-3242RE-LEVERE-LEVE
    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 [RE-LEVE]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    RE-LEVE
    RE-LEVE
    78297908 2884355 Live/Registered
    Kentucky Equine Research, Inc.
    2003-09-09
    RE-LEVE
    RE-LEVE
    78131833 not registered Dead/Abandoned
    Releve Group, LLC
    2002-05-29
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