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 89 of 153 · 3,057 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 3875bde5-2e1a-5fdf-e063-6294a90a3c0d 2025-06-26 Warnings Exact identifier application number: M017 SupreH Bee Venom Arthritis Pain Relieving Cream SUPREH BEE VENOM ARTHRITIS PAIN RELIEVING CREAM Shenzhen Xinxin Yunhai Technology Co., Ltd. 3876cc44-7f3a-b084-e063-6294a90a6142 2025-06-26 Warnings Exact identifier application number: M017 MediBalm HYDROCORTISONE BalmRx, LLC 324dd151-84c5-3e2f-e063-6394a90a569d 2025-06-26 Warnings Exact identifier application number: M017 PHIZICO Pain Relief MENTHOL ER3 BRANDS INC. 72715dc5-d1e7-4b4b-8e28-4e367abba322 2025-06-25 Warnings Exact identifier application number: M017 Diva Cramp Care Cream METHYL SALICYLATE, MENTHOL, CAMPHOR Avaria Health & Beauty Corp 37368566-b14e-4d5c-bdde-6eea9073974f 2025-06-25 Warnings Exact identifier application number: M017 H2Ocean NOTHING TATTOO GLIDE AFTERCARE MAX STRENGTH LIDOCAINE HCL H2Ocean, LLC 386bf11b-1d71-44bf-e063-6394a90a2817 2025-06-25 Warnings Exact identifier application number: M017 Burn Relief Extra Strength Kool-Down LIDOCAINE - 3.9% Kool-Down Inc 827fec2f-db3c-adbb-e053-2a91aa0a7c17 2025-06-25 Warnings Exact identifier application number: M017 Hilook Blue Gel Anesthetic LIDOCAINE Guangdong Aimu Biological Technology Co., Ltd 1b9db681-a297-5aa9-e063-6394a90a80ea 2025-06-25 Warnings Exact identifier application number: M017 Hilook Numbing Cream LIDOCAINE Guangdong Aimu Biological Technology Co., Ltd 1b9f1a4c-ca0b-d820-e063-6394a90a3239 2025-06-25 Warnings Exact identifier application number: M017 Lidocaine Knee Pain Relief Gel-Patch LIDOCAINE Guangzhou Zhupuyou E-commerce Co., Ltd 384c1ff8-80bd-86cb-e063-6394a90a2d65 2025-06-24 Warnings Exact identifier application number: M017 Aroamas Cot Nicotine Transdermal Patches Kit NICOTINE TRANSDERMAL PATCHES PCHEERY LLC 38576022-9413-c9af-e063-6294a90afd46 2025-06-24 Warnings Exact identifier application number: M017 NERVE REVERSE PAIN RELIEF MENTHOL Pogue Medical Services da97bcc6-5aa8-48e2-a2c2-c937745bf6d3 2025-06-23 Warnings Exact identifier application number: M017 Medterra Pain Relief Menthol Roll-On MENTHOL Respect Manufacturing Corporation 05a6067a-287a-52d4-e063-6394a90a2c4e 2025-06-23 Warnings Exact identifier application number: M017 Medterra Pain Relief 500mg Hemp Menthol Cream MENTHOL Respect Manufacturing Corporation 06c4640a-ee42-5d1a-e063-6394a90ad254 2025-06-23 Warnings Exact identifier application number: M017 Medterra Pain Relief 1000mg Hemp Menthol Cream MENTHOL Respect Manufacturing Corporation 06e944e8-71f6-9fe9-e063-6294a90a8c37 2025-06-23 Warnings Exact identifier application number: M017 Procure gel MENTHOL TWIN MED, LLC e69c0b68-d408-9fd2-e053-2a95a90ac934 2025-06-20 Warnings Exact identifier application number: M017 A Health Itch Relief Gel ITCH RELIEF GEL Bionpharma, Inc. 38040732-48c9-3533-e063-6394a90af10a 2025-06-20 Warnings Exact identifier application number: M017 SCHOELIF Numbing Cream NUMBING CREAM Guangzhou Qiexiran Cosmetics Co., Ltd. 37eaabb7-884e-0bd5-e063-6294a90ae063 2025-06-19 Warnings Exact identifier application number: M017 Re-Lieved Lidocaine Patch LIDOCAINE PATCH 4% Transfer Technology 37ee539c-df7e-511d-e063-6394a90a4469 2025-06-19 Warnings Exact identifier application number: M017 Re-Lieved Lidocaine Patch LIDOCAINE PATCH 4% Transfer Technology 37eef80a-556f-b090-e063-6294a90a151b 2025-06-19 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