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
- CAMPHOR (SYNTHETIC); CAPSAICIN; HISTAMINE DIHYDROCHLORIDE; MENTHOL GLUCURONIDE; METHYL SALICYLATE
- Active strength
- 3; .025; .025; 6; 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sombra Max
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CAMPHOR (SYNTHETIC) | 3 g/100g |
| CAPSAICIN | .025 g/100g |
| HISTAMINE DIHYDROCHLORIDE | .025 g/100g |
| MENTHOL GLUCURONIDE | 6 g/100g |
| METHYL SALICYLATE | 12 g/100g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5TJD82A1ET, S07O44R1ZM, 3POA0Q644U, WW64GZ6LQY, LAV5U5022Y |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| 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 |
Packages#
Package NDC, 11-digit format, Description table| 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 | Historical |
| 61577-3440-2 | 61577344002 | 1 g in 1 PACKET (61577-3440-2) | 1 g | 2026-01-01 | No | No | Historical |