RE-LEVE
- Product NDC
- 61577-3242
- 11-digit product format
- 615773242
- Labeler code
- 61577
- Product ID
- 61577-3242_364d60f1-80e4-1ee1-e063-6394a90ab590
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- MENTHOL
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- SOMBRA COSMETICS INC.
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2016-10-05
- Substance
- MENTHOL
- Active strength
- .06 g/g
- 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 |
|---|---|---|---|---|---|---|---|
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 61577-3242-4 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 61577-3242-5 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 61577-3242-4 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 61577-3242-5 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 61577-3242-4 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 61577-3242-5 | I | Inactivated by FDA | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 61577-3242-4 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 61577-3242-5 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 61577-3242-5 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 61577-3242-4 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 61577-3242-5 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 61577-3242-4 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 61577-3242-5 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 61577-3242-4 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
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
- RE-LEVE
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MENTHOL | .06 g/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| L7T10EIP3A | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| b4b39d79-0439-41e7-adca-e5ccb8f44e40 | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 61577-3242-4 | 2025-01-30 | Ré-LEVE Natural Analgesic Pain Relieving Formula |
| 61577-3242-5 | 2025-01-30 | Ré-LEVE Natural Analgesic Pain Relieving Formula |
| 61577-3242-4 | 2023-03-08 | Ré-LEVE Natural Analgesic Pain Relieving Formula |
| 61577-3242-5 | 2023-03-08 | Ré-LEVE Natural Analgesic Pain Relieving Formula |
| 61577-3242-4 | 2023-01-30 | Ré-LEVE Natural Analgesic Pain Relieving Formula |
| 61577-3242-5 | 2023-01-30 | Ré-LEVE Natural Analgesic Pain Relieving Formula |
| 61577-3242-4 | 2020-03-06 | Ré-LEVE Natural Analgesic Pain Relieving Formula |
| 61577-3242-5 | 2020-03-06 | Ré-LEVE Natural Analgesic Pain Relieving Formula |
| 61577-3242-4 | 2020-01-31 | Ré-LEVE Natural Analgesic Pain Relieving Formula |
| 61577-3242-5 | 2020-01-31 | Ré-LEVE Natural Analgesic Pain Relieving Formula |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61577-3242-4 | RE-LEVE | 113.6 g in 1 JAR | GEL | 113.6 | 6 | |
| 61577-3242-5 | RE-LEVE | 113.6 g in 1 TUBE | GEL | 113.6 | 6 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 61577-3242 | RE-LEVE (MENTHOL) GEL [SOMBRA COSMETICS] | 5 | Current NDC, Legacy NDC, 2 package rows | 20230309_b4b39d79-0439-41e7-adca-e5ccb8f44e40.zip |
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 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 61577-3242-4 | 61577324204 | 113.6 g in 1 JAR (61577-3242-4) | 113.6 g | 2016-10-05 | 0000-00-00 | No | No | Current |
| 61577-3242-5 | 61577324205 | 113.6 g in 1 TUBE (61577-3242-5) | 113.6 g | 2017-10-05 | 0000-00-00 | No | No | Current |