NDC 53145-002

Hielo Ardiente

Menthol

Hielo Ardiente is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by Menper Distributors, Inc.. The primary component is Menthol.

• Product ID: 53145-002_4000c212-7fc1-47b8-a4c0-29fce9835e3d
• NDC: 53145-002
• Product Type: Human Otc Drug
• Proprietary Name: Hielo Ardiente
• Generic Name: Menthol
• Dosage Form: Gel
• Route of Administration: TOPICAL
• Marketing Start Date: 2012-02-21
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part348
• Labeler Name: Menper Distributors, Inc.
• Substance Name: MENTHOL
• Active Ingredient Strength: 4840 mg/g
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 53145-002-01

454 g in 1 JAR (53145-002-01)

• Marketing Start Date: 2012-02-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 53145-002-01 [53145000201]

Hielo Ardiente GEL

• Marketing Category: OTC monograph not final
• Application Number: part348
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2012-02-21
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
MENTHOL	4840 mg/g

OpenFDA Data

• SPL SET ID: 97ec516c-d2bc-47ce-82fe-bd68445d9570
• Manufacturer:
  • Menper Distributors, Inc.
• UNII:
  • L7T10EIP3A

NDC Crossover Matching brand name "Hielo Ardiente" or generic name "Menthol"

NDC	Brand Name	Generic Name
53145-002	Hielo Ardiente	Hielo Ardiente
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