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 68 of 151 · 3,010 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Aulief Topical Pain Reliever MENTHOL AND CAMOHOR China-Gel, LLC 8647dcc3-1dbc-1093-e053-2991aa0a1ab9 2025-11-04 Warnings Exact identifier application number: M017 China-Gel Topical Pain Reliever MENTHOL AND CAMOHOR (SYNTHETIC) China-Gel, LLC 254abae9-ef1b-5a90-e054-00144ff88e88 2025-11-04 Warnings Exact identifier application number: M017 Pain Relief Gel-Tube MENTHOL Bullet point LLC 42c93789-9758-54b7-e063-6394a90ac398 2025-11-04 Warnings Exact identifier application number: M017 Tattoo care TATTOO CARE CREAM Perfso (HK) Co., Limited 42d0f56f-9cb1-8e19-e063-6394a90aa3e0 2025-11-04 Warnings Exact identifier application number: M017 CORE RELIEF CAMPHOR, MENTHOL Copper Joint, LLC 42d17270-f58d-9d69-e063-6294a90a4078 2025-11-04 Warnings Exact identifier application number: M017 Lidocaine and Menthol LIDOCAINE AND MENTHOL Marcella Health d25f25ee-79f8-49e7-9715-0aae305b73e5 2025-11-03 Warnings Exact identifier application number: M017 Calamine Plus Pramoxine HCl CALAMINE PLUS NO TOUCH SPRAY Premier Brands of America Inc. 36481d67-2346-470b-e063-6294a90aae99 2025-11-03 Warnings Exact identifier application number: M017 Lidocaine Numbing Cream LIDOCAINE 5% YYBA Corp 1319ee69-8b3f-5815-e063-6294a90a5ad5 2025-11-03 Warnings Exact identifier application number: M017 Goodsense Extra Strength Cold and Hot Medicated MENTHOL Geiss, Destin and Dunn, Inc. 7585d111-775f-4fb6-a485-28cd99d88852 2025-10-31 Warnings Exact identifier application number: M017 Topcare Cold and Hot Medicated MENTHOL Topco Associates LLC 8739aedd-165c-5ae0-e053-2a91aa0afcd0 2025-10-31 Warnings Exact identifier application number: M017 CVS Medicated Heat 1 ct CAPSAICIN CVS Pharmacy, Inc. d41dce5b-e698-4930-8869-040b2a973f25 2025-10-31 Warnings Exact identifier application number: M017 Coralite Medicated Heat CAPSAICIN United Exchange Corp. a0b89c7e-80bc-43c4-840c-5fd567f60b21 2025-10-31 Warnings Exact identifier application number: M017 Dragon with Arnical Pain Relief MENTHOL Genomma Lab USA Inc. b4cbb7b6-cb71-9721-e053-2995a90a2b2c 2025-10-31 Warnings Exact identifier application number: M017 Gemachlich ZuHause NEUROPATHY SOLID Ointment. GEMACHLICH ZUHAUSE NEUROPATHY SOLID OINTMENT. Guangdong Quadrant Ecological Technology Co., Ltd. 425b1b9d-c33a-05e9-e063-6394a90a97a6 2025-10-30 Warnings Exact identifier application number: M017 Gemachlich ZuHause NEUROPATHY Spray. GEMACHLICH ZUHAUSE NEUROPATHY SPRAY. Guangdong Quadrant Ecological Technology Co., Ltd. 425b8259-af38-8d68-e063-6394a90a1120 2025-10-30 Warnings Exact identifier application number: M017 Family Care Muscle and Joint MENTHOL United Exchange Corp. 959af9f4-7188-91a1-e053-2995a90a4665 2025-10-30 Warnings Exact identifier application number: M017 CVS Maximum Strength Boil Relief BENZOCAINE CVS Pharmacy, Inc. 0761b866-af34-42bd-adc9-3d229170d01c 2025-10-30 Warnings Exact identifier application number: M017 CVS Cold and Hot MENTHOL CVS Pharmacy a44ca52d-fec8-0e8c-e053-2995a90a2e60 2025-10-30 Warnings Exact identifier application number: M017 CVS CAPSAICIN CAPSAICIN CVS PHARMACY 9b551fe3-3842-482a-9042-63de5ad39884 2025-10-30 Warnings Exact identifier application number: M017 TopCare Health Pain Relief MENTHOL, CAMPHOR, AND METHYL SALICYLATE Topco Associates LLC dac364ef-6dcd-3fc6-e053-2a95a90a9bb2 2025-10-30 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