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 23 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Kevo-Prophen JUNIPER TAR Faeve, LLC 4fe773a8-77cd-831e-e063-6294a90ae2ca 2026-04-20 Warnings Exact identifier application number: M017 BeeVenom METHYL SALICYLATE Menper Distributors, Inc. 4fe7a986-336d-ad4e-e063-6294a90a0b8a 2026-04-20 Warnings Exact identifier application number: M017 Benzodent BENZOCAINE Focus Consumer Healthcare, LLC 5fdcb871-d387-6352-e053-2991aa0a09da 2026-04-20 Warnings Exact identifier application number: M017 Tecnu Calagel DIPHENHYDRAMINE HYDROCHLORIDE Tec Laboratories Inc. 8bc9cbfe-1dd4-18ed-e053-2a95a90a7966 2026-04-20 Warnings Exact identifier application number: M017 Aemerry Numbing Cream MENTHOL 5% Da Capo Prima LLC 4fefddaf-19c8-86b4-e063-6294a90abffc 2026-04-20 Warnings Exact identifier application number: M017 Sting Relief Swab BENZOCAINE 4 Visions LLC 4fc7a356-2f1d-85af-e063-6394a90aec6b 2026-04-18 Warnings Exact identifier application number: M017 Equate Lidocaine and Menthol Paraben Free LIDOCAINE 4% PLUS MENTHOL 1% Walmart Stores Inc 4fa917de-bc46-0b8d-e063-6294a90a218a 2026-04-17 Warnings Exact identifier application number: M017 LidoPro LIDOCAINE AND MENTHOL Advanced Rx of Tennessee, LLC 4faa515f-6040-d948-e063-6294a90a187f 2026-04-17 Warnings Exact identifier application number: M017 Coleman Bite and Sting Relief EXTERNAL ANESTHETIC AND FIRST AID ANTISEPTIC Wisconsin Pharmacal Company 4fadf1f1-478a-5104-e063-6294a90a10cb 2026-04-17 Warnings Exact identifier application number: M017 Ice Gel ICE COLD ANALGESIC MENTHOL Universal Distribution Center LLC 4f921ced-7722-cba5-e063-6294a90a650b 2026-04-16 Warnings Exact identifier application number: M017 Walgreens Capsaicin Hot Patch CAPSAICIN Walgreen Co. 41e959d8-f6ac-f5b4-e063-6294a90abd96 2026-04-16 Warnings Exact identifier application number: M017 Walgreens Cold Therapy Pain Relieving Patch MENTHOL Walgreen Co. 41e7574a-348f-8eb8-e063-6294a90a6e90 2026-04-16 Warnings Exact identifier application number: M017 Coleman Sting and Bite Relief EXTERNAL ANALGESIC AND FIRST AID ANTISEPTIC Wisconsin Pharmacal Company 4f94ab35-3099-716c-e063-6294a90a8bea 2026-04-16 Warnings Exact identifier application number: M017 Kroger Witch Hazel WITCH HAZEL Kroger Co. 461407d0-fbf6-47e9-e063-6394a90a9a83 2026-04-16 Warnings Exact identifier application number: M017 Stopain Extra Strength Gel MENTHOL Troy Manufacturing, Inc. 86fe4e8c-5279-445a-a19a-e694eac785fd 2026-04-16 Warnings Exact identifier application number: M017 Stopain Clinical MENTHOL, UNSPECIFIED FORM Troy Manufacturing, Inc. 4503208f-2808-4727-8066-c431230bd70b 2026-04-16 Warnings Exact identifier application number: M017 EXTRA STRENGTH STOPAIN COLD PAIN RELIEVING ROLL ON MENTHOL TROY MANUFACTURING, INC 895896dc-0762-40a7-8313-cca10ce68984 2026-04-16 Warnings Exact identifier application number: M017 HealthWise Medicated Cold Hot 5% MENTHOL Veridian Healthcare 4f9b1b2d-1acc-e0a7-e063-6394a90aadbc 2026-04-16 Warnings Exact identifier application number: M017 Lidoease 2% LIDOCAINE HCL 2% PureTek Corporation 3ba0c0ff-0f7a-7a29-e063-6294a90a547a 2026-04-16 Warnings Exact identifier application number: M017 Walgreens Lidocaine Pain Relieving Patch Assorted LIDOCAINE Walgreen Co. 41e98f15-669f-4543-e063-6294a90a1ef7 2026-04-15 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