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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- RE-LEVE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MENTHOL | .06 g/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | L7T10EIP3A |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| 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 table| 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 |
Packages#
Package NDC, 11-digit format, Description table| 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 |