DOCOSANOL
- Product NDC
- 0536-1427
- 11-digit product format
- 005361427
- Labeler code
- 0536
- Product ID
- 0536-1427_9b89030f-1b9a-4519-96d0-5e40b9e1debd
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Docosanol
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Rugby Laboratories
- Application
- ANDA215839
- Marketing category
- ANDA
- Marketing start
- 2024-05-22
- 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 |
|---|
| 0536-1427-04 | DOCOSANOL | 2 g in 1 TUBE | CREAM | 2 | | 1 |
| 0536-1427-04 | DOCOSANOL | 1 in 1 PACKAGE | CREAM | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0536-1427 | DOCOSANOL CREAM [RUGBY LABORATORIES] | 1 | Current NDC, 2 package rows | 20240524_6f8d6375-8188-42e9-a048-e8a554122ff3.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 |
|---|
| 0536-1427-04 | 00536142704 | 1 TUBE in 1 PACKAGE (0536-1427-04) / 2 g in 1 TUBE | 1 tube | 2024-05-22 | No | No | Current |