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 ID53145-002_4000c212-7fc1-47b8-a4c0-29fce9835e3d
NDC53145-002
Product TypeHuman Otc Drug
Proprietary NameHielo Ardiente
Generic NameMenthol
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2012-02-21
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart348
Labeler NameMenper Distributors, Inc.
Substance NameMENTHOL
Active Ingredient Strength4840 mg/g
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 53145-002-01

454 g in 1 JAR (53145-002-01)
Marketing Start Date2012-02-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53145-002-01 [53145000201]

Hielo Ardiente GEL
Marketing CategoryOTC monograph not final
Application Numberpart348
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-02-21
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
MENTHOL4840 mg/g

OpenFDA Data

SPL SET ID:97ec516c-d2bc-47ce-82fe-bd68445d9570
Manufacturer
UNII

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

NDCBrand NameGeneric Name
53145-002Hielo ArdienteHielo Ardiente
0363-1071Cherry Cough DropMenthol
0363-1086Cherry Cough DropsMenthol
0363-0150Cool n Heat Patch for Arm, Neck and LegMenthol
0363-0152Cool n Heat Patch for BackMenthol
0363-1072Honey Lemon Cough DropMenthol
0363-1087Honey Lemon Cough DropMenthol
0219-0203Humphreys Bendito Alcoholadomenthol
0363-1070Menthol Cough Dropmenthol
0363-1084Menthol Cough Dropmenthol
0067-2067Mineral IceMenthol
0316-0226Mineral IceMenthol
0316-0290Mineral Ice Quick Dry FoamMenthol
0363-0151Pain Relieving PatchMenthol
0363-1077SF Honey Lemon Cough DropMenthol
0363-1085SF Menthol Cough DropMenthol
0363-0043Studio 35 Medicated BodyMenthol
0363-0864Walgreens Cold Pain ReliefMENTHOL
0363-0874Walgreens Cold Pain ReliefMENTHOL
0363-0966Walgreens Sunburn ReliefMenthol

Trademark Results [Hielo Ardiente]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HIELO ARDIENTE
HIELO ARDIENTE
85322119 4134338 Live/Registered
ALPER HOLDINGS INC.
2011-05-16

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