NDC 43749-321

Avedana Cool Hot Ice

Menthol

Avedana Cool Hot Ice is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by Unipack, Inc.. The primary component is Menthol.

• Product ID: 43749-321_1850af06-be68-45cd-a107-604506bef374
• NDC: 43749-321
• Product Type: Human Otc Drug
• Proprietary Name: Avedana Cool Hot Ice
• Generic Name: Menthol
• Dosage Form: Gel
• Route of Administration: TOPICAL
• Marketing Start Date: 2017-11-04
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part348
• Labeler Name: Unipack, Inc.
• Substance Name: MENTHOL
• Active Ingredient Strength: 2 g/100g
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 43749-321-08

227 g in 1 JAR (43749-321-08)

• Marketing Start Date: 2017-11-04
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 43749-321-08 [43749032108]

Avedana Cool Hot Ice GEL

• Marketing Category: OTC monograph not final
• Application Number: part348
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2017-11-04

Drug Details

Active Ingredients

Ingredient	Strength
MENTHOL	2 g/100g

OpenFDA Data

• SPL SET ID: 619c8e3f-0cad-4eb1-8dbb-632f3db74ba3
• Manufacturer:
  • Unipack, Inc.
• UNII:
  • L7T10EIP3A
• RxNorm Concept Unique ID - RxCUI:
  • 311502
• UPC Code:
  • 0751393006086

NDC Crossover Matching brand name "Avedana Cool Hot Ice" or generic name "Menthol"

NDC	Brand Name	Generic Name
43749-321	Avedana Cool Hot Ice	Avedana Cool Hot Ice
0363-1071	Cherry Cough Drop	Menthol
0363-1086	Cherry Cough Drops	Menthol
0363-0150	Cool n Heat Patch for Arm, Neck and Leg	Menthol
0363-0152	Cool n Heat Patch for Back	Menthol
0363-1072	Honey Lemon Cough Drop	Menthol
0363-1087	Honey Lemon Cough Drop	Menthol
0219-0203	Humphreys Bendito Alcoholado	menthol
0363-1070	Menthol Cough Drop	menthol
0363-1084	Menthol Cough Drop	menthol
0067-2067	Mineral Ice	Menthol
0316-0226	Mineral Ice	Menthol
0316-0290	Mineral Ice Quick Dry Foam	Menthol
0363-0151	Pain Relieving Patch	Menthol
0363-1077	SF Honey Lemon Cough Drop	Menthol
0363-1085	SF Menthol Cough Drop	Menthol
0363-0043	Studio 35 Medicated Body	Menthol
0363-0864	Walgreens Cold Pain Relief	MENTHOL
0363-0874	Walgreens Cold Pain Relief	MENTHOL
0363-0966	Walgreens Sunburn Relief	Menthol