NDC 13709-311

Cool n Heat

Cool N Heat

Cool n Heat is a Topical Spray in the Human Otc Drug category. It is labeled and distributed by Neilmed Pharmaceuticals, Inc.. The primary component is Menthol.

• Product ID: 13709-311_a24cde17-280a-8358-e053-2a95a90af67d
• NDC: 13709-311
• Product Type: Human Otc Drug
• Proprietary Name: Cool n Heat
• Generic Name: Cool N Heat
• Dosage Form: Spray
• Route of Administration: TOPICAL
• Marketing Start Date: 2018-11-09
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part348
• Labeler Name: NeilMed Pharmaceuticals, Inc.
• Substance Name: MENTHOL
• Active Ingredient Strength: 160 mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 13709-311-01

118 mL in 1 CAN (13709-311-01)

• Marketing Start Date: 2018-11-09
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 13709-311-01 [13709031101]

Cool n Heat SPRAY

• Marketing Category: OTC monograph not final
• Application Number: part348
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2018-11-09

NDC 13709-311-03 [13709031103]

Cool n Heat SPRAY

• Marketing Category: OTC monograph not final
• Application Number: part348
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2018-11-09
• Marketing End Date: 2020-04-15

Drug Details

Active Ingredients

Ingredient	Strength
MENTHOL	160 mg/mL

OpenFDA Data

• SPL SET ID: a24cde17-280b-8358-e053-2a95a90af67d
• Manufacturer:
  • NeilMed Pharmaceuticals, Inc.
• UNII:
  • L7T10EIP3A
• RxNorm Concept Unique ID - RxCUI:
  • 1430458
• UPC Code:
  • 0311917206479

NDC Crossover Matching brand name "Cool n Heat" or generic name "Cool N Heat"

NDC	Brand Name	Generic Name
0363-3207	Cool n Heat	Menthol 16%
13709-311	Cool n Heat	Cool n Heat
13710-311	Cool n Heat	Cool n Heat