Sombra Max
- Product NDC
- 61577-3440
- 11-digit product format
- 615773440
- Labeler code
- 61577
- Product ID
- 61577-3440_41623a46-e6e8-907e-e063-6394a90afc4c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Sombra Max
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Sombra Cosmetics Inc.
- Application
- M017
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-01-01
- Substance
- MENTHOL GLUCURONIDE; HISTAMINE DIHYDROCHLORIDE; CAMPHOR (SYNTHETIC); CAPSAICIN; METHYL SALICYLATE
- Active strength
- 6; .025; 3; .025; 12 g/100g; g/100g; g/100g; g/100g; g/100g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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
- Sombra Max
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MENTHOL GLUCURONIDE | 6 g/100g |
| HISTAMINE DIHYDROCHLORIDE | .025 g/100g |
| CAMPHOR (SYNTHETIC) | 3 g/100g |
| CAPSAICIN | .025 g/100g |
| METHYL SALICYLATE | 12 g/100g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| WW64GZ6LQY | Internal UNII lookup |
| 3POA0Q644U | Internal UNII lookup |
| 5TJD82A1ET | Internal UNII lookup |
| S07O44R1ZM | Internal UNII lookup |
| LAV5U5022Y | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 41623a46-e6e7-907e-e063-6394a90afc4c | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 473d070d-1c38-488e-b991-c4d1bf45aab8 | Product name | 1 | 20210201 |
| dea2eded-d1e7-46bb-9a3d-f8dc20de6277 | Product name | 1 | 20190408 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61577-3440-1 | Sombra Max | 1 g in 1 CONTAINER | CREAM | 1 | 1 | |
| 61577-3440-2 | Sombra Max | 1 g in 1 PACKET | CREAM | 1 | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Eagle Brand Muscle Rub | MENTHOL, METHYL SALICYLATE | Borden Company (Private) Limited | 06cb845c-cc53-1f1d-e063-6394a90a8c01 | 2026-04-27 | Warnings | M017 |
| Eagle Brand Medicated Oil Aromatic | CAMPHOR, MENTHOL, METHYL SALICYLATE | PT. EAGLE INDO PHARMA | 0ef7c3aa-94a3-9fe9-e063-6394a90ab13d | 2026-04-27 | Warnings | M017 |
| Eagle Brand Medicated Oil | MENTHOL, METHYL SALICYLATE | PT. EAGLE INDO PHARMA | 5071f145-49f7-0855-e063-6394a90a8f26 | 2026-04-27 | Warnings | M017 |
| Eagle Brand Medicated Oil Refresh | CAMPHOR, MENTHOL | PT. EAGLE INDO PHARMA | 09260c31-56a3-07aa-e063-6394a90a95fd | 2026-04-27 | Warnings | M017 |
| Eagle Brand Muscle Rub | MENTHOL, METHYL SALICYLATE | PT. EAGLE INDO PHARMA | 5072ad57-9fa7-ddba-e063-6394a90a319b | 2026-04-27 | Warnings | M017 |
| Eagle Brand Medicated Roll On Refresh | CAMPHOR, MENTHOL | PT. EAGLE INDO PHARMA | 09235f26-2262-6ca2-e063-6394a90ad8f1 | 2026-04-27 | Warnings | M017 |
| Eagle Brand Medicated Roll On Aromatic | CAMPHOR, MENTHOL, METHYL SALICYLATE | PT. EAGLE INDO PHARMA | 0f333f93-bec6-72d5-e063-6394a90a4e3f | 2026-04-27 | Warnings | M017 |
| HIP PAIN RELIEF ROLL-ON | LIDOCAINE AND MENTHOL | Guangzhou Liuquanmiao Import & Export Trade Co., Ltd. | 502f1f9e-8552-ca7b-e063-6394a90a7c53 | 2026-04-24 | Warnings | M017 |
| SOMBRA WARM THERAPY | MENTHOL CAMPHOR | SOMBRA COSMETICS INC. | de78dba9-53b3-4dbd-9dd2-6a692378da34 | 2026-04-24 | Warnings | M017 |
| Rite Aid Itch Relief | DIPHENHYDRAMINE HCL 2%, ZINC ACETATE 0.1% | Rite Aid | e285df43-317c-d862-e053-2a95a90acdce | 2026-04-23 | Warnings | M017 |
| FixMySkin Healing Balm Unflavored | HYDROCORTISONE | Lovely Skin, Inc. | 9ff8db07-ad6d-4865-a534-94bd8312957e | 2026-04-23 | Warnings | M017 |
| DCH Labs Cortisone | HYDROCORTISONE 1% | Derma Care Research Labs | 5025f53a-02e0-0f6a-e063-6394a90adbbf | 2026-04-23 | Warnings | M017 |
| Hydrocortisone 1% | HYDROCORTISONE | Preferred Pharmaceuticals Inc. | e0f46445-64c5-4f5d-90b0-3fa07ed7d1b4 | 2026-04-22 | Warnings | M017 |
| Dr. Carrasco Pain Relief | MENTHOL | Carrasco Enterprises, Inc. | befa8526-f468-428e-a829-422c2ea48612 | 2026-04-21 | Warnings | M017 |
| HealthWise Feminine Anti-itch Cream | BENZOCAINE, RESORCINOL | Veridian Healthcare | 4ff88b9e-5869-a1cb-e063-6294a90a87b7 | 2026-04-21 | Warnings | M017 |
| SOMBRA COOL THERAPY | MENTHOL | SOMBRA COSMETICS INC. | 87e9b16b-1cab-48f7-b9e4-1c3eaeeb3ca3 | 2026-04-21 | Warnings | M017 |
| Careland Lidocaine Pain Relieving | LIDOCAINE | Planet (Anhui) Pharmaceutical Co., Ltd. | c4c86a8f-1d57-49d2-a65f-acb0dccf2f87 | 2026-04-21 | Warnings | M017 |
| KOXUO Arnica Bruise Cream | ARNICA BRUISE CREAM | Guangzhou Jingliang Cosmetics Co., Ltd. | 5003bf83-fa01-b01a-e063-6294a90ad37f | 2026-04-21 | Warnings | M017 |
| KT Pain Relief Cream Magnesium with Arnica and 4% Lidocaine | KT PAIN RELIEF CREAM MAGNESIUM WITH ARNICA AND 4% LIDOCAINE ROLLON | Clarion Brands LLC | 4f82993c-ebc4-5787-e063-6294a90a12d6 | 2026-04-20 | Warnings | M017 |
| KT Pain Relief Cream Magnesium with Cooling 5% Menthol | KT PAIN RELIEF CREAM MAGNESIUM WITH COOLING 5% MENTHOL | Clarion Brands LLC | 4fe64056-f3c6-bc76-e063-6294a90a7e62 | 2026-04-20 | Warnings | M017 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 61577-3440-1 | 61577344001 | 1 g in 1 CONTAINER (61577-3440-1) | 1 g | 2026-01-01 | No | No | Current |
| 61577-3440-2 | 61577344002 | 1 g in 1 PACKET (61577-3440-2) | 1 g | 2026-01-01 | No | No | Current |