NDC 69365-005

NOPEN HOT

Glycol Salicylate, Levomenthol

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

• Product ID: 69365-005_73da2dad-c94e-f85f-e053-2991aa0a176f
• NDC: 69365-005
• Product Type: Human Otc Drug
• Proprietary Name: NOPEN HOT
• Generic Name: Glycol Salicylate, Levomenthol
• Dosage Form: Patch
• Route of Administration: TRANSDERMAL
• Marketing Start Date: 2018-08-17
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part348
• Labeler Name: JW HOLDINGS CORPORATION
• Substance Name: MENTHOL, UNSPECIFIED FORM; GLYCOL SALICYLATE
• Active Ingredient Strength: 35 mg/1; mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 69365-005-01

5 PATCH in 1 POUCH (69365-005-01)

• Marketing Start Date: 2018-08-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69365-005-01 [69365000501]

NOPEN HOT PATCH

• Marketing Category: OTC monograph not final
• Application Number: part348
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2018-08-17
• Marketing End Date: 2019-12-31

Drug Details

Active Ingredients

Ingredient	Strength
MENTHOL, UNSPECIFIED FORM	35 mg/1

OpenFDA Data

• SPL SET ID: 54b9d276-4ff2-2cc2-e054-00144ff8d46c
• Manufacturer:
  • JW HOLDINGS CORPORATION
• UNII:
  • L7T10EIP3A
  • 3I1VBB7AXH
• RxNorm Concept Unique ID - RxCUI:
  • 2053867

NDC Crossover Matching brand name "NOPEN HOT" or generic name "Glycol Salicylate, Levomenthol"

NDC	Brand Name	Generic Name
69365-005	NOPEN HOT	GLYCOL SALICYLATE, LEVOMENTHOL
69365-006	NOPEN COOL	GLYCOL SALICYLATE, LEVOMENTHOL