DOCOSANOL
- Product NDC
- 0713-0353
- 11-digit product format
- 007130353
- Labeler code
- 0713
- Product ID
- 0713-0353_e4d903b2-6585-4e80-a58e-128fe69cf1d4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Docosanol
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Cosette Pharmaceuticals, Inc.
- Application
- ANDA215839
- Marketing category
- ANDA
- Marketing start
- 2024-01-04
- Substance
- DOCOSANOL
- Active strength
- 100 mg/g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- DOCOSANOL
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DOCOSANOL | 100 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9G1OE216XY |
| Rxcui | 797534 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0713-0353-02 | DOCOSANOL | 2 g in 1 TUBE | CREAM | 2 | | 1 |
| 0713-0353-02 | DOCOSANOL | 1 in 1 CARTON | CREAM | 1 | | 1 |
| 0713-0353-62 | DOCOSANOL | 1 in 1 CARTON | CREAM | 1 | | 1 |
| 0713-0353-62 | DOCOSANOL | 2 g in 1 BOTTLE, PUMP | CREAM | 2 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0713-0353 | DOCOSANOL CREAM [COSETTE PHARMACEUTICALS, INC.] | 1 | Current NDC, 4 package rows | 20240105_ccbb5e6d-cb85-449c-a480-28225d744f4d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0713-0353-02 | 00713035302 | 1 TUBE in 1 CARTON (0713-0353-02) / 2 g in 1 TUBE | 1 tube | 2024-01-04 | No | No | Current |
| 0713-0353-62 | 00713035362 | 1 BOTTLE, PUMP in 1 CARTON (0713-0353-62) / 2 g in 1 BOTTLE, PUMP | | 2024-01-04 | No | No | Current |