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 60 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sohm Pain Away MENTHOL, CAMPHOR SOHM, Inc 86632acf-80ae-48d7-a0bb-7ec980326bae 2025-11-25 Warnings Exact identifier application number: M017 HealthWise Lidocaine Pain Relief LIDOCAINE 4% Veridian Healthcare 6f2332c0-e078-40a8-9564-f47d21bc491b 2025-11-25 Warnings Exact identifier application number: M017 JUST CBD ROLL-ON WARMING CAMPHOR Just Brands LLC 44779065-5f57-8f01-e063-6394a90a3f8e 2025-11-25 Warnings Exact identifier application number: M017 JUST CBD ROLL-ON COOLING MENTHOL Just Brands LLC 44786cb6-176e-cc6e-e063-6394a90a54ad 2025-11-25 Warnings Exact identifier application number: M017 Diphenhydramine HCl and Zinc Acetate EXTRA STRENGTH ITCH RELIEF VALU MERCHANDISERS, CO 3e9c0f5b-cb76-475b-9a2b-39afa1eeb9ff 2025-11-24 Warnings Exact identifier application number: M017 Menthol MAXIMUM STRENGTH MEDICATED FOOT POWDER VALU MERCHANDISERS, CO 89a5c4bb-442f-d3f0-e053-2a95a90a51bd 2025-11-24 Warnings Exact identifier application number: M017 Dragon Pain Relieving Balm CAMPHOR, MENTHOL AMERICANNA WELLNESS, INC. 0d11ab8e-d3ea-c7ef-e063-6294a90ae0a3 2025-11-24 Warnings Exact identifier application number: M017 Dragon Pain Relieving CAMPHOR, MENTHOL AMERICANNA WELLNESS, INC. 0d113dec-8832-d984-e063-6394a90ae7b3 2025-11-24 Warnings Exact identifier application number: M017 Dragon Pain Relieving Balm CAMPHOR, MENTHOL AMERICANNA WELLNESS, INC. 0d12f03f-dd8b-0be5-e063-6294a90a43db 2025-11-24 Warnings Exact identifier application number: M017 Thermacare Heat Therapy Max Strength Lidocaine Pain Relief Gel THERMACARE HEAT THERAPY MAX STRENGTH LIDOCAINE PAIN RELIEF GEL Clarion Brands LLC 445db02a-c8e8-6ebb-e063-6294a90a4301 2025-11-24 Warnings Exact identifier application number: M017 Dragon Pain Relieving Balm CAMPHOR, MENTHOL AMERICANNA WELLNESS, INC. 0d129641-eaea-c3ee-e063-6394a90aa58f 2025-11-24 Warnings Exact identifier application number: M017 Dragon Pain Relieving CAMPHOR, MENTHOL AMERICANNA WELLNESS, INC. 0d1059cc-1b0b-4e7b-e063-6294a90a56ea 2025-11-24 Warnings Exact identifier application number: M017 GuruNanda Pain Relief MENTHOL AND CAMPHOR GURUNANDA, LLC 3ca78342-cc6d-5f6b-e063-6294a90a3f1c 2025-11-24 Warnings Exact identifier application number: M017 Dragon Pain Relieving CAMPHOR, MENTHOL AMERICANNA WELLNESS, INC. 0d118256-90ee-28ef-e063-6394a90a21e8 2025-11-24 Warnings Exact identifier application number: M017 health beyond HYDROCORTISONE Nantong Health & Beyond Hygienic Products Inc. bdcd5b01-f5e2-4519-bf4d-25e3cc7e67af 2025-11-23 Warnings Exact identifier application number: M017 NicDuic Quit Smoking Nicotine Patches 3 Step NICOTINE PATCHES Shenzhen Paxi Trading Co., Ltd. 4429fea8-46f8-8f7f-e063-6394a90a34b4 2025-11-22 Warnings Exact identifier application number: M017 NicDuic Quit Smoking Nicotine Patches 2 Step NICOTINE PATCHES Shenzhen Paxi Trading Co., Ltd. 442a926b-d7c1-4e35-e063-6394a90ad948 2025-11-22 Warnings Exact identifier application number: M017 NicDuic Quit Smoking Nicotine Patches 1 Step NICOTINE PATCHES Shenzhen Paxi Trading Co., Ltd. 442aae32-4ac6-5dd6-e063-6294a90aad02 2025-11-22 Warnings Exact identifier application number: M017 NicDuic Quit Smoking Nicotine Patches 1-3 Step 21MG NICOTINE PATCHES Shenzhen Paxi Trading Co., Ltd. 442ae0fa-a1ed-7901-e063-6294a90ab717 2025-11-22 Warnings Exact identifier application number: M017 IceQuake Lidocaine Analgesic LIDOCAINE HYDROCHLORIDE Dextrum Laboratories, Inc 441daa6f-f273-ac09-e063-6394a90a252c 2025-11-21 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