Home NDC 53145-002-01 Hielo Ardiente
Product NDC 53145-002
Requested package NDC 53145-002-01
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 2027-12-31
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 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 53145-002 53145-002-01 I Inactivated by FDA excluded / ndc_excluded.zip e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 53145-002 53145-002-01 I Inactivated by FDA excluded / ndc_excluded.zip 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 53145-002 53145-002-01 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 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 2027-12-31 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 45 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join LUBRICAINE LIDOCAINE 4% ESBA LABORATORIES INC. 9d7416b1-607d-34e0-e053-2a95a90aa3c3 2026-01-08 Warnings Exact identifier application number: M017 0.5% LIDOCAINE BURN RELIEF LIDOCAINE HYDROCHLORIDE Universal Distribution Center LLC 0a1aeff0-bade-457b-a0ac-099d646c0b2e 2026-01-08 Warnings Exact identifier application number: M017 4% MENTHOL COLD THERAPY MENTHOL Universal Distribution Center LLC 66892993-a755-4584-b2a8-2e8d7ac70593 2026-01-08 Warnings Exact identifier application number: M017 Private Label Antifungal Barrier Cream 2% MICONAZOLE NITRATE CREAM Swiss-American CDMO, LLC e74bddea-c1ac-4e4e-84bd-5a9defb85b2d 2026-01-08 Warnings Exact identifier application number: M017 2.0% LIDOCAINE BURN LIDOCAINE HYDROCHLORIDE Universal Distribution Center LLC e1911279-85f7-4053-b6da-8f4e991347a2 2026-01-08 Warnings Exact identifier application number: M017 POMG PAIN RELIEF ROLLER LIDOCAINE HYDROCHLORIDE, MENTHOL POMG LLC 1fa980fb-fc0e-fdd0-e063-6394a90adc13 2026-01-07 Warnings Exact identifier application number: M017 Artridon Glucosamine MENTHOL, METHYL SALICYLATE Pharmadel LLC 73572156-4cce-0669-e053-2991aa0aaecc 2026-01-07 Warnings Exact identifier application number: M017 HealthWise Cooling Pain Relief MENTHOL Veridian Healthcare 6e2ad0ab-e3a8-4e3a-8f1d-2cd6351185bd 2026-01-07 Warnings Exact identifier application number: M017 Hydrocortisone 1% Anti-Itch Cream HYDROCORTISONE DLC Laboratories, Inc. 16eeec2c-065d-4da0-e063-6294a90a3873 2026-01-07 Warnings Exact identifier application number: M017 Maximum Strength Hydrocortisone HYDROCORTISONE DLC Laboratories, Inc caf50f12-f35c-4e9e-8ef7-3b0c84e225ee 2026-01-07 Warnings Exact identifier application number: M017 EARTHS CARE MUSCLE AND JOINT RUB CAMPHOR DLC Laboratories, Inc. 71e33e06-4dc3-4ead-a122-ff89d93a64de 2026-01-07 Warnings Exact identifier application number: M017 Amour CBD PAIN RELIEF CREAM SVD Premium Products 95b45e79-b1e7-17b2-e053-2995a90a8836 2026-01-07 Warnings Exact identifier application number: M017 Tiger Balm Active Muscle METHYL SALICYLATE AND MENTHOL, UNSPECIFIED FORM Haw Par Healthcare Ltd. 845a4ead-f9c0-4009-bcae-b17cd388439b 2026-01-07 Warnings Exact identifier application number: M017 3X Medicated Toothache and Gum Gel BENZOCAINE Rite Aid 996f7989-17ce-5b28-e053-2995a90af8b8 2026-01-06 Warnings Exact identifier application number: M017 QNTAMAX Muscle and Joint Pain Relieving CAMPHOR (SYNTHETIC), MENTHOL Qntamax LLC 6622b94c-824e-4e84-a8d8-b60bb0b866e2 2026-01-06 Warnings Exact identifier application number: M017 Winco Muscle and Joint Pain Relief Gel 2oz WINCO BENGAY VANISHING SCENT MUSCLE AND JOINT PAIN RELIEF WINCO FOODS, LLC 47bedf4e-4036-cf43-e063-6394a90a91d6 2026-01-06 Warnings Exact identifier application number: M017 Pain Relief Hot Patch MENTHOL AND CAPSAICIN Universal Distribution Center LLC 110bcb16-ef0b-4bc8-8877-173a0494e1ad 2026-01-06 Warnings Exact identifier application number: M017 WOFANLI Quit Smoking Nicotine Patches NICOTINE PATCHES Shenzhen Paxi Trading Co., Ltd. 4582b4e9-0c24-069d-e063-6394a90a6f4b 2026-01-05 Warnings Exact identifier application number: M017 Lidocaine 4% Topical Anesthetic Cream LIDOCAINE 4% Oncor Pharmaceuticals 1baaa669-05af-4024-a0ba-ee3451756f6a 2026-01-05 Warnings Exact identifier application number: M017 TheraCare Pain Relief MENTHOL Veridian Healthcare 6834a6de-4d1d-4e40-945d-ec5c267abd14 2026-01-05 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