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 49 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Trauma Less MENTHOL Natures Formulae Health Products Ltd. 781e94d5-1d34-7202-e053-2991aa0ae768 2025-12-29 Warnings Exact identifier application number: M017 Quality Choice Cold Therapy Gel MENTHOL Chain Drug Marketing Association, Inc. f9c659cd-e7fa-ac2d-e053-6294a90a2573 2025-12-29 Warnings Exact identifier application number: M017 PAIN RELIEF PATCHES LIDOCAINE Harris Teeter 5a0501e8-bc06-4e33-8db8-93b21a715141 2025-12-29 Warnings Exact identifier application number: M017 Hot and Cold Medicated Patch MENTHOL Harris Teeter 9debd4ef-c21b-41ae-afd1-58f47c51c99c 2025-12-29 Warnings Exact identifier application number: M017 Maximum OTC Strength Feminine Anti-Itch Creme BENZOCAINE, RESORCINOL Quality Choice (CHAIN DRUG MARKETING ASSOCIATION) 0e9a711c-ddf4-af63-e063-6294a90a0ebe 2025-12-29 Warnings Exact identifier application number: M017 Pain Relief Patches CAMPHOR, MENTHOL, METHYL SALICYLATE Harris Teeter 3f5b4eee-49c4-408c-9af2-e7924c26ac63 2025-12-29 Warnings Exact identifier application number: M017 talc-free medicated body MENTHOL Davion, Inc 27b9b4dc-4d4f-4e9d-b388-a7c6807a0e9b 2025-12-29 Warnings Exact identifier application number: M017 H-E-B Medicated Corn Starch Foot Powder MENTHOL Davion, Inc a6675e00-bc6b-4466-a283-4cece5f91970 2025-12-29 Warnings Exact identifier application number: M017 Maximum Strength Medicated Foot Powder MENTHOL Davion, Inc 7b442d99-ac19-4f65-828d-954c5350ef5a 2025-12-29 Warnings Exact identifier application number: M017 HEB Medicated Cornstarch Body Powder MENTHOL Davion, Inc df1331fb-48df-4f21-8564-0468078fd12d 2025-12-29 Warnings Exact identifier application number: M017 Honest Med Capsaicin Patch CAPSAICIN Proper Buys LLC 30169d44-b1b2-5c0f-e063-6294a90ae159 2025-12-28 Warnings Exact identifier application number: M017 Honest Med Lidocaine Lavender Roll-on LIDOCAINE HCL Proper Buys LLC 2dcd40a9-3fdd-a71e-e063-6294a90a704f 2025-12-28 Warnings Exact identifier application number: M017 Honest Med Lidocaine Pain Relief Patch LIDOCAINE Proper Buys LLC 13a5243f-7116-e4da-e063-6394a90aa543 2025-12-28 Warnings Exact identifier application number: M017 CVS Health Pain-Relieving Patch MENTHOL, METHYL SALICYLATE, CAMPHOR CVS Pharmacy, Inc. 1f90899c-eeca-2362-e063-6294a90aa0da 2025-12-28 Warnings Exact identifier application number: M017 CVS Health Cooling Patch MENTHOL CVS Pharmacy, Inc 1f90cefe-bcce-5e17-e063-6294a90a5736 2025-12-28 Warnings Exact identifier application number: M017 Point Relief LidoSpot with Menthol LIDOCAINE, MENTHOL Fabrication Enterprises f0c69693-bfea-4006-9620-63b222d25d38 2025-12-28 Warnings Exact identifier application number: M017 DISCOUNT DRUG MART PAIN RELIEF PATCHES LIDOCAINE Discount Drug Mart, Inc e36e7d0a-d554-4601-b535-b41ee84a6b24 2025-12-28 Warnings Exact identifier application number: M017 Medicated Pain Relief Patches CAMPHOR, MENTHOL, METHYL SALICYLATE Discount Drug Mart, Inc c01e1a14-bfbc-4c52-8a67-b77acf2d8853 2025-12-28 Warnings Exact identifier application number: M017 TopCare Pain Relief Patch LIDOCAINE, MENTHOL Topco Associates LLC d4c89c4f-d69a-7786-e053-2995a90a71e7 2025-12-28 Warnings Exact identifier application number: M017 Kroger Lidocaine Pain Relieving LIDOCAINE HCL Kroger Company 12d94ba6-56ac-3816-e063-6394a90a44c6 2025-12-28 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