NDC 69365-006

NOPEN COOL

Glycol Salicylate, Levomenthol

NOPEN COOL is a Transdermal Patch in the Human Otc Drug category. It is labeled and distributed by Jw Holdings Corporation. The primary component is Glycol Salicylate; Menthol, Unspecified Form.

Product ID69365-006_73da2dad-c93c-f85f-e053-2991aa0a176f
NDC69365-006
Product TypeHuman Otc Drug
Proprietary NameNOPEN COOL
Generic NameGlycol Salicylate, Levomenthol
Dosage FormPatch
Route of AdministrationTRANSDERMAL
Marketing Start Date2018-08-17
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart348
Labeler NameJW HOLDINGS CORPORATION
Substance NameGLYCOL SALICYLATE; MENTHOL, UNSPECIFIED FORM
Active Ingredient Strength35 mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 69365-006-01

5 PATCH in 1 POUCH (69365-006-01)
Marketing Start Date2018-08-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69365-006-01 [69365000601]

NOPEN COOL PATCH
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-08-17
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
GLYCOL SALICYLATE35 mg/1

OpenFDA Data

SPL SET ID:67f7944d-4048-2305-e053-2991aa0af616
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2053867
  • NDC Crossover Matching brand name "NOPEN COOL" or generic name "Glycol Salicylate, Levomenthol"

    NDCBrand NameGeneric Name
    69365-006NOPEN COOLGLYCOL SALICYLATE, LEVOMENTHOL
    69365-005NOPEN HOTGLYCOL SALICYLATE, LEVOMENTHOL

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