Docosanol
- Product NDC
- 21922-023
- 11-digit product format
- 219220023
- Labeler code
- 21922
- Product ID
- 21922-023_a1fe87d9-27cf-4ff0-9e70-52b038882e36
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Docosanol
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Encube Ethicals, Inc.
- Application
- ANDA212385
- Marketing category
- ANDA
- Marketing start
- 2022-10-10
- 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 |
|---|
| 21922-023-17 | Docosanol | 2 g in 1 BOTTLE, PUMP | CREAM | 2 | | 2 |
| 21922-023-17 | Docosanol | 1 in 1 PACKAGE | CREAM | 1 | | 2 |
| 21922-023-18 | Docosanol | 1 in 1 PACKAGE | CREAM | 1 | | 2 |
| 21922-023-18 | Docosanol | 2 g in 1 TUBE | CREAM | 2 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 21922-023 | DOCOSANOL CREAM [ENCUBE ETHICALS PRIVATE LIMITED] | 1 | Current NDC, Legacy NDC, 4 package rows | 20221020_5b3137d3-c186-4c5d-89d2-ec5d1c3da8cd.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 21922-023-17 | 21922002317 | 1 BOTTLE, PUMP in 1 PACKAGE (21922-023-17) / 2 g in 1 BOTTLE, PUMP | | 2022-10-10 | 0000-00-00 | No | No | Current |
| 21922-023-18 | 21922002318 | 1 TUBE in 1 PACKAGE (21922-023-18) / 2 g in 1 TUBE | 1 tube | 2022-10-10 | 0000-00-00 | No | No | Current |