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 58 of 151 · 3,020 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lidocaine Patch LIDOCAINE Shenzhen Finona Information Technology Co., Ltd 38767081-7011-6602-e063-6394a90a2784 2025-12-03 Warnings Exact identifier application number: M017 4% Lidocaine Maximum Strength Pain Relief LIDOCAINE Shenzhen Finona Information Technology Co., Ltd 3e5a5165-a773-0501-e063-6294a90ae2f4 2025-12-03 Warnings Exact identifier application number: M017 Leader Lidocaine LIDOCAINE HCL CARDINAL HEALTH cece6765-0e2f-5ce9-e053-2995a90a3758 2025-12-03 Warnings Exact identifier application number: M017 Westlake Lidocaine LIDOCAINE HCL Westlake Pharma LLC 0c586a14-1a2a-9f42-e063-6294a90a16c1 2025-12-03 Warnings Exact identifier application number: M017 CVS Lidocaine Maximum Strength LIDOCAINE HCL CVS Pharmacy 87490c0f-a4d9-740e-e053-2a95a90a4724 2025-12-03 Warnings Exact identifier application number: M017 CVS Maximum Strength Burn LIDOCAINE HYDROCHLORIDE 4% CVS Pharmacy 4510f379-c5a4-92c3-e063-6294a90a0a32 2025-12-03 Warnings Exact identifier application number: M017 LidoPatch Pain Relief LIDOCAINE, MENTHOL JAR Laboratories 07289aa1-43ed-df31-e063-6394a90a764a 2025-12-03 Warnings Exact identifier application number: M017 Equate Pain Relief Cream 4% LIDOCAINE HCL Walmart, Inc 7d8e8a9a-5474-4c7b-e053-2991aa0a29f5 2025-12-03 Warnings Exact identifier application number: M017 Solarcaine Burn Pain Relief 4oz SOLARCAINE BURN PAIN RELIEF 4OZ WellSpring Pharmaceutical Corporation 14f23c28-c713-4868-9f46-66363bf94b2c 2025-12-03 Warnings Exact identifier application number: M017 ElixirCortiRelief HYDROCORTISONE ELIXIR HEALTHCARE USA, LLC. a6ca66f3-9759-4c98-a758-45700bc08352 2025-12-02 Warnings Exact identifier application number: M017 Pain Relief Gel-Patch LIDOCAINE 4% Trifecta Pharmaceuticals USA, LLC. 12a27ce7-c547-7134-e063-6394a90a94bd 2025-12-02 Warnings Exact identifier application number: M017 5Kind DMSO MENTHOL, METHYL SALICYLATE 5KIND TRADING LTD 6a6c7241-f544-4784-9581-f5b172fdbec7 2025-12-02 Warnings Exact identifier application number: M017 PEDIADERMICS ECZEMA 2 HYDROCORTISONE RENU LABORATORIES, LLC da840bf6-ed65-bafc-e053-2a95a90a92d5 2025-12-02 Warnings Exact identifier application number: M017 Thera Plus Maximum Strength Hydrocortisone HYDROCORTISONE Fourstar Group USA, Inc 7d4e21d1-2914-4690-9084-a52abeab0958 2025-12-02 Warnings Exact identifier application number: M017 Rugby Capsaicin Cream CAPSAICIN Rugby Laboratories 9eca34f1-e91a-3ac1-e053-2a95a90a9bd9 2025-12-02 Warnings Exact identifier application number: M017 Leader Capsaicin Pain Relief Cream CAPSAICIN Cardinal Health 110 dba LEADER a5620709-0fed-4979-e053-2a95a90ac654 2025-12-02 Warnings Exact identifier application number: M017 Hydrocortisone Acetate Antipruritic (Anti-Itch) HYDROCORTISONE ACETATE Sun Pharmaceutical Industries, Inc. 9f0b09e7-6cfd-4fd6-8631-67799edf4e08 2025-12-02 Warnings Exact identifier application number: M017 POMG NIGHT TIME PAIN RELIEF ROLLER LIDOCAINE HYDROCHLORIDE POMG LLC 28d7dfb0-a94c-90de-e063-6294a90a036a 2025-12-02 Warnings Exact identifier application number: M017 Thermacare Max Strength Lidocaine THERMACARE MAX STRENGTH LIDOCAINE Clarion Brands LLC 44fed887-d1e0-d205-e063-6294a90ac416 2025-12-02 Warnings Exact identifier application number: M017 SUNSET COOLING PAIN RELIEF ROLL-ON MENTHOL SUNSET NOVELTIES, INC 45037bc1-aa03-11ae-e063-6294a90a6c96 2025-12-02 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