NDC 61577-3216

SOMBRA WARM THERAPY

Menthol Camphor

SOMBRA WARM THERAPY is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by Sombra Cosmetics Inc.. The primary component is Camphor (synthetic); Menthol.

Product ID61577-3216_745ebcb7-b9b1-415e-825f-0e72b075d066
NDC61577-3216
Product TypeHuman Otc Drug
Proprietary NameSOMBRA WARM THERAPY
Generic NameMenthol Camphor
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2022-05-18
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart348
Labeler NameSOMBRA COSMETICS INC.
Substance NameCAMPHOR (SYNTHETIC); MENTHOL
Active Ingredient Strength0 g/g; g/g
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 61577-3216-1

3628.7 g in 1 BOTTLE, PUMP (61577-3216-1)
Marketing Start Date2022-05-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61577-3216-4 [61577321604]

SOMBRA WARM THERAPY GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Billing UnitGM
Marketing Start Date2016-06-14
Inactivation Date2020-01-31
Reactivation Date2020-03-05

NDC 61577-3216-1 [61577321601]

SOMBRA WARM THERAPY GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-06-14
Inactivation Date2020-01-31
Reactivation Date2020-03-05

NDC 61577-3216-3 [61577321603]

SOMBRA WARM THERAPY GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Billing UnitGM
Marketing Start Date2016-06-14
Inactivation Date2020-01-31
Reactivation Date2020-03-05

NDC 61577-3216-6 [61577321606]

SOMBRA WARM THERAPY GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-06-14
Inactivation Date2020-01-31
Reactivation Date2020-03-05

NDC 61577-3216-8 [61577321608]

SOMBRA WARM THERAPY GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Billing UnitGM
Marketing Start Date2016-06-13
Marketing End Date2016-07-11

NDC 61577-3216-9 [61577321609]

SOMBRA WARM THERAPY GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-06-14
Inactivation Date2020-01-31
Reactivation Date2020-03-05

NDC 61577-3216-7 [61577321607]

SOMBRA WARM THERAPY GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-06-14
Inactivation Date2020-01-31
Reactivation Date2020-03-05

NDC 61577-3216-2 [61577321602]

SOMBRA WARM THERAPY GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-06-14
Inactivation Date2020-01-31
Reactivation Date2020-03-05

NDC 61577-3216-5 [61577321605]

SOMBRA WARM THERAPY GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Billing UnitGM
Marketing Start Date2016-06-14
Inactivation Date2020-01-31
Reactivation Date2020-03-05

Drug Details

Active Ingredients

IngredientStrength
MENTHOL.03 g/g

OpenFDA Data

SPL SET ID:de78dba9-53b3-4dbd-9dd2-6a692378da34
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1090954
  • 630714
  • UPC Code
  • 0763669000728
  • NDC Crossover Matching brand name "SOMBRA WARM THERAPY" or generic name "Menthol Camphor"

    NDCBrand NameGeneric Name
    61577-3216SOMBRA WARM THERAPYMENTHOL CAMPHOR
    61577-4020SOMBRA WARM THERAPYMENTHOL CAMPHOR
    61577-3610DEEP REMEDYMENTHOL CAMPHOR
    59321-011Gold Edition Ultra Zheng Gu ShuiMenthol Camphor
    61577-3501GREEN BAMBOOMENTHOL CAMPHOR
    61577-4080HealQu Warm Therapy GelMENTHOL CAMPHOR
    61821-100Hua TuoMenthol Camphor
    73412-001Hua TuoMenthol Camphor
    20276-210Lucky Blue IceMenthol Camphor
    47046-167Lucky Blue IceMenthol Camphor
    61577-2301MUSCLE EASEMENTHOL CAMPHOR
    72380-521OPITOX TOPICALMENTHOL CAMPHOR
    61577-7365PAIN NO MORE THERAPYMENTHOL CAMPHOR
    61577-5310SNAP CRACKMENTHOL CAMPHOR
    61577-7050Sombra CBD Warm TherapyMenthol Camphor
    61577-7010Sombra Plus CBD 1000mg Warm TheapyMenthol Camphor
    61577-7120Sombra Plus CBD 2000mg Warm TheapyMenthol Camphor
    61577-2280SORE NO MOREMENTHOL CAMPHOR
    61577-7011Sore No More Warm Therapry Plus CBD 1000mgMenthol Camphor
    61577-7012Sore No More Warm Therapry Plus CBD 2000mgMenthol Camphor
    61577-7055Sore No More Warm Therapy Plus CBD 500mg Natural Pain Relieving GelMenthol Camphor
    61577-1400Tonys Warm TherapyMenthol Camphor

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