Home NDC 53145-002 Hielo Ardiente
Product NDC 53145-002
11-digit product format 531450002
Labeler code 53145
Product ID 53145-002_3a876b4d-bba4-c8d4-e063-6394a90abaa0
Type HUMAN OTC DRUG
Nonproprietary name Menthol
Dosage form GEL
Route TOPICAL
Labeler Menper Distributors, Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2012-02-21
Substance MENTHOL
Active strength 1 g/100g
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 53145-002-01 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 53145-002-01 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 53145-002-01 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Hielo Ardiente
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 1 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L7T10EIP3A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1039043 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53145-002-01 Hielo Ardiente 454 g in 1 JAR GEL 454 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MENTHOL ACTIVE INGREDIENT L7T10EIP3A HIELO ARDIENTE (MENTHOL) GEL [MENPER DISTRIBUTORS, INC.] 1 MENTHOL ACTIVE MOIETY L7T10EIP3A HIELO ARDIENTE (MENTHOL) GEL [MENPER DISTRIBUTORS, INC.] 1 CAMPHOR (SYNTHETIC) INACTIVE INGREDIENT 5TJD82A1ET HIELO ARDIENTE (MENTHOL) GEL [MENPER DISTRIBUTORS, INC.] 1 CARBOMER 940 INACTIVE INGREDIENT 4Q93RCW27E HIELO ARDIENTE (MENTHOL) GEL [MENPER DISTRIBUTORS, INC.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD HIELO ARDIENTE (MENTHOL) GEL [MENPER DISTRIBUTORS, INC.] 1 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 HIELO ARDIENTE (MENTHOL) GEL [MENPER DISTRIBUTORS, INC.] 1 METHYLCHLOROISOTHIAZOLINONE INACTIVE INGREDIENT DEL7T5QRPN HIELO ARDIENTE (MENTHOL) GEL [MENPER DISTRIBUTORS, INC.] 1 POLYSORBATE 20 INACTIVE INGREDIENT 7T1F30V5YH HIELO ARDIENTE (MENTHOL) GEL [MENPER DISTRIBUTORS, INC.] 1 TRIETHANOLAMINE BENZOATE INACTIVE INGREDIENT M3EN4GC19W HIELO ARDIENTE (MENTHOL) GEL [MENPER DISTRIBUTORS, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R HIELO ARDIENTE (MENTHOL) GEL [MENPER DISTRIBUTORS, INC.] 1
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 38 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join TheraCare Muscle and Joint Gel Vanishing Scent MENTHOL 2.5% Veridian Healthcare 494d2a85-45a8-12a2-e063-6294a90a391b 2026-01-26 Warnings Exact identifier application number: M017 Lidocaine Pain Relief LIDOCAINE Trifecta Pharmaceuticals USA, LLC. 493c09d0-16d7-7413-e063-6394a90aa052 2026-01-26 Warnings Exact identifier application number: M017 Topcare Medicated Pain Relieving Patch 60ct TOPCARE PAIN RELIEF PATCH EXTRA STRENGTH Topco Associates LLC 4953c12b-ca6d-d21e-e063-6294a90ac990 2026-01-26 Warnings Exact identifier application number: M017 Dr Sabharwals MENTHOL 5% PATCH Dr. Sabharwal's Wound Care 1025b986-a1e5-701d-e063-6294a90a33fd 2026-01-24 Warnings Exact identifier application number: M017 Target Up and Up Pain Relief Menthol Topical Analgesic MENTHOL Target Corporation 4910f32f-c639-0215-e063-6394a90a1c7b 2026-01-23 Warnings Exact identifier application number: M017 Rapidol HYDROCORTISONE Pharmadel LLC 19a1f1e2-bc6b-7153-e063-6294a90ab115 2026-01-23 Warnings Exact identifier application number: M017 CVS 9083 Maximum Strength Lidocaine 4 Pain Relief Patch 1ct Large LIDOCAINE CVS PHARMACY, INC 4914965f-1164-e20e-e063-6294a90ac221 2026-01-23 Warnings Exact identifier application number: M017 THE GOO MEDICATED PAIN RELIEF METHYL SALICYLATE, MENTHOL, CAMPHOR APSM PERFORMANCE, LLC db4c321c-8cdc-5a11-e053-2995a90a91a1 2026-01-23 Warnings Exact identifier application number: M017 Dr Sabharwals LIDOCAINE 4% AND MENTHOL 1% PATCH Dr. Sabharwal's Wound Care 10249d0f-5ee1-6892-e063-6394a90a967e 2026-01-23 Warnings Exact identifier application number: M017 Easment DMSO cream MENTHOL 1.00% Easment LLC 48f5544e-1cfd-864a-e063-6394a90a71f1 2026-01-22 Warnings Exact identifier application number: M017 Aveeno 1% Hydrocortisone Anti-Itch Cream HYDROCORTISONE Kenvue Brands LLC 1ac0ac4e-af76-9a3e-e063-6394a90a1269 2026-01-22 Warnings Exact identifier application number: M017 RAYO ACTIVE ICE MENTHOL, CAMPHOR Quimicas Handal de Centroamerica SA de CV 09e4a36b-020a-c5b1-e063-6394a90a3e31 2026-01-22 Warnings Exact identifier application number: M017 X-Treme Freeze COLD THERAPY GEL Dynarex Corporation 79f0802f-03ad-bf8f-e053-2991aa0ae4b5 2026-01-22 Warnings Exact identifier application number: M017 Anti Itch HYDROCORTISONE HyVee Inc ae31f1f5-db70-45cf-850e-67bfe6860748 2026-01-21 Warnings Exact identifier application number: M017 ULTRA RELIEF MENTHOL, CAMPHOR CHEMCO CORPORATION 48ea80cf-af54-ce5f-e063-6394a90ac493 2026-01-21 Warnings Exact identifier application number: M017 Healthy Back Institute Rub On Relief ANALGESIC Eagle Labs Inc. 17dff3c1-3c0b-16f6-e063-6394a90a3c05 2026-01-21 Warnings Exact identifier application number: M017 Pain Relief ANALGESIC Fullstack Fulfillment 2a433cee-8b6f-c280-e063-6394a90ae25a 2026-01-21 Exact identifier application number: M017 Walgreens Anti Itch Cream ANTI ITCH CREAM Walgreens Company b545553a-283a-48af-adc5-763758a9ff24 2026-01-21 Warnings Exact identifier application number: M017 CVS Health Maximum Strength Lidocaine Pain Relief Cream Plus Menthol LIDOCAINE HCL, MENTHOL CVS Pharmacy 8aaffa3f-f82f-470c-902d-f366f1a66305 2026-01-21 Warnings Exact identifier application number: M017 LIGHTS Instant Sting Relief Pad BENZOCAINE Lights Medical Manufacture Co., Ltd. 28dd82a7-f360-a022-e063-6394a90a3a76 2026-01-21 Warnings Exact identifier application number: M017
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 53145-002-01 53145000201 454 g in 1 JAR (53145-002-01) 454 g 2012-02-21 0000-00-00 No No Current