NDC 67777-144

X-Treme Freeze

Cold Therapy Gel

X-Treme Freeze is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by Dynarex Corporation. The primary component is Menthol.

Product ID67777-144_79f0802f-03ae-bf8f-e053-2991aa0ae4b5
NDC67777-144
Product TypeHuman Otc Drug
Proprietary NameX-Treme Freeze
Generic NameCold Therapy Gel
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2018-08-17
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart348
Labeler NameDynarex Corporation
Substance NameMENTHOL
Active Ingredient Strength4 g/100g
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 67777-144-10

200 BOX in 1 CASE (67777-144-10) > 100 PACKET in 1 BOX > 2.88 g in 1 PACKET
Marketing Start Date2018-08-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67777-144-10 [67777014410]

X-Treme Freeze GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-08-17

NDC 67777-144-40 [67777014440]

X-Treme Freeze GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-08-17

NDC 67777-144-20 [67777014420]

X-Treme Freeze GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-08-17

NDC 67777-144-70 [67777014470]

X-Treme Freeze GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-08-17

Drug Details

Active Ingredients

IngredientStrength
MENTHOL4 g/100g

OpenFDA Data

SPL SET ID:79f0802f-03ad-bf8f-e053-2991aa0ae4b5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 415974

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