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.
| 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 |
|---|---|
| MENTHOL | 1 g/100g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| L7T10EIP3A | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1039043 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 97ec516c-d2bc-47ce-82fe-bd68445d9570 | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53145-002-01 | 2023-07-28 | C162847 | 48780-1 | 9d75b9d1-0744-f424-e053-dadaa90a57ce | Hielo Ardiente |
| 53145-002-01 | 2021-04-21 | C162847 | 48780-1 | 9d75b9d1-0744-f424-e053-dadaa90a57ce | Hielo Ardiente |
| 53145-002-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-0744-f424-e053-dadaa90a57ce | Hielo Ardiente |
DailyMed Package Descriptions#
| 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#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Calamine Plus | CALAMINE, PRAMOXINE HYDROCHLORIDE | Kroger Company | 44fdd5a4-3cac-15e5-e063-6294a90adb52 | 2026-08-26 | Warnings | M017 |
| Lidocaine Pain Relief | LIDOCAINE | Cardinal Health, 110 dba LEADER | 025d508b-ec4f-466c-b3e8-ba9b18d07b46 | 2026-08-26 | Warnings | M017 |
| Inknows Lidocaine Pain Relief Gel-Patch | LIDOCAINE PAIN RELIEF GEL-PATCH | Henan Enokon Medical Instrument Co., Ltd. | 59eb9c12-9e00-0171-e063-6394a90a8342 | 2026-08-25 | Warnings | M017 |
| Lidomar | LIDOMAR | Oncora Pharma, LLC | 215bfdca-60bf-480b-b02e-902de52fe5e8 | 2026-08-25 | Warnings | M017 |
| Hydrocortisone | HYDROCORTISONE | Amazon.com Services LLC | 5f87d7fb-f258-48b0-8b60-1055e22ebd71 | 2026-08-25 | Warnings | M017 |
| HEEL PAIN RELIEF ROLL-ON | LIDOCAINE AND MENTHOL | Guangzhou Liuquanmiao Import & Export Trade Co., Ltd. | 59c7e13f-b9ea-023a-e063-6294a90a79e0 | 2026-08-24 | Warnings | M017 |
| KNEE PAIN RELIEF ROLL-ON | LIDOCAINE AND MENTHOL | Guangzhou Liuquanmiao Import & Export Trade Co., Ltd. | 59c8b33a-7d4f-2c6e-e063-6394a90a7929 | 2026-08-24 | Warnings | M017 |
| Bovonte Numbing Cream | NUMBING CREAM | Guangzhou Jingliang Cosmetics Co., Ltd. | 5958cc29-c449-56a7-e063-6394a90a960b | 2026-08-24 | Warnings | M017 |
| HUSTLE BUTTER NUMBING | LIDOCAINE HYDROCHLORIDE | H.B.D. D.I.S.T. INC. | d7dfb312-6c80-4a2d-b8b2-d9891cb0b74e | 2026-08-24 | Warnings | M017 |
| JELVOXA NECK PAIN RELIEVING | MENTHOL | Wuhan Ruihengjie Technology Co., Ltd. | 59a3d60a-26b5-e6a6-e063-6294a90a42bd | 2026-08-22 | Warnings | M017 |
| JELVOXA DMSO | CAMPHOR CAPSAICIN MENTHOL | Wuhan Ruihengjie Technology Co., Ltd. | 59a43e2c-d258-34b5-e063-6394a90a09bf | 2026-08-22 | Warnings | M017 |
| Capsaicin 0.035 Percent | CAPSAICIN | Preferred Pharmaceuticals Inc. | 0fabc025-4208-45f5-b3c2-543ae3a2df41 | 2026-08-21 | Warnings | M017 |
| Claravie | HYDROCORTISONE ACETATE | Gentell LLC | 598d224b-d12e-89bf-e063-6394a90a84dc | 2026-08-21 | Warnings | M017 |
| ETERNAL SPIRIT BEAUTY PAINLESS PAIN RELIEVING | MENTHOL, CAMPHOR | Worldwide Cosmetics, Inc | 3b8c2419-7a78-2731-e054-00144ff8d46c | 2026-08-21 | Warnings | M017 |
| PARCHE FRIO | METHYL SALICYLATE, MENTHOL, AND CAMPHOR PATCH | DW SUPPORT LLC | 5970a6f7-b273-9bb1-e063-6394a90afc79 | 2026-08-21 | Warnings | M017 |
| Enokon Lidocaine Pain Relief Patch | LIDOCAINE PAIN RELIEF PATCH | Henan Enokon Medical Instrument Co., Ltd. | 5976e667-e506-1d11-e063-6394a90a6809 | 2026-08-20 | Warnings | M017 |
| MQUPIN TIGER Patch | TIGER PATCH | Zhengzhou Miaoqi Medical Technology Co., Ltd. | 5977cbb5-94c7-cb24-e063-6294a90a2e07 | 2026-08-20 | Warnings | M017 |
| MQUPIN Nicotine Patches | NICOTINE PATCHES | Zhengzhou Miaoqi Medical Technology Co., Ltd. | 5978258a-549e-50e6-e063-6394a90a3d86 | 2026-08-20 | Warnings | M017 |
| Claravie | CAMPHOR | Gentell LLC | 5978bdab-5359-be9a-e063-6394a90a5a32 | 2026-08-20 | Warnings | M017 |
| Rugby PAIN RELIEF PATCHES | LIDOCAINE | RUGBY LABORATORIES | b34e40c8-a257-46cf-9399-f55df9b4102d | 2026-08-20 | Warnings | M017 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1039043 | menthol 1 % Topical Gel | PSN | 97ec516c-d2bc-47ce-82fe-bd68445d9570 | 4 |
| 1039043 | menthol 0.01 MG/MG Topical Gel | SCD | 97ec516c-d2bc-47ce-82fe-bd68445d9570 | 4 |
| 1039043 | menthol 1 % Topical Gel | SY | 97ec516c-d2bc-47ce-82fe-bd68445d9570 | 4 |
Packages#
| 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 |