DOCOSANOL
- Product NDC
- 61269-881
- 11-digit product format
- 612690881
- Labeler code
- 61269
- Product ID
- 61269-881_f2757843-0b78-46be-a22c-bcdf3a433464
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- DOCOSANOL
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- H2-Pharma, LLC
- Application
- ANDA212385
- Marketing category
- ANDA
- Marketing start
- 2025-04-10
- 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 |
|---|
| 61269-881-35 | DOCOSANOL | 2 g in 1 TUBE | CREAM | 2 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61269-881 | DOCOSANOL CREAM [H2-PHARMA, LLC] | 1 | Current NDC, 1 package rows | 20250418_f0b3a78b-b14c-4869-ba3b-d04ffa62e1d5.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 |
|---|
| 61269-881-35 | 61269088135 | 2 g in 1 TUBE (61269-881-35) | 2 g | 2025-04-10 | No | No | Current |