SOMBRA COOL THERAPY
- Product NDC
- 61577-3103
- 11-digit product format
- 615773103
- Labeler code
- 61577
- Product ID
- 61577-3103_4ffb85fd-c60e-3f70-e063-6294a90a6fdc
- 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
- 2026-04-21
- Substance
- MENTHOL
- Active strength
- .06 g/g
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- SOMBRA COOL THERAPY
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MENTHOL | .06 g/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | L7T10EIP3A |
| Rxcui | 415976 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 61577-3103-1 | SOMBRA COOL THERAPY | 85.05 g in 1 TUBE | GEL | 85.05 | | 12 |
DailyMed Socrata Ingredients#
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 61577-3103-1 | 61577310301 | 85.05 g in 1 TUBE (61577-3103-1) | 85.05 g | 2026-04-21 | No | No | Current |