Docosanol
- Product NDC
- 46708-682
- 11-digit product format
- 467080682
- Labeler code
- 46708
- Product ID
- 46708-682_91169ef2-b68b-4da3-b698-2bfc01f441cf
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Docosanol
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA215839
- Marketing category
- ANDA
- Marketing start
- 2025-05-08
- 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 |
|---|
| 46708-682-01 | Docosanol | 2 g in 1 TUBE | CREAM | 2 | | 1 |
| 46708-682-01 | Docosanol | 1 in 1 PACKAGE | CREAM | 1 | | 1 |
| 46708-682-03 | Docosanol | 2 g in 1 BOTTLE, PUMP | CREAM | 2 | | 1 |
| 46708-682-03 | 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 |
|---|
| 46708-682 | DOCOSANOL CREAM [ALEMBIC PHARMACEUTICALS LIMITED] | 1 | Current NDC, 4 package rows | 20250509_a87a077d-9b0e-490d-b4ac-26c7045828db.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 |
|---|
| 46708-682-01 | 46708068201 | 1 TUBE in 1 PACKAGE (46708-682-01) / 2 g in 1 TUBE | 1 tube | 2025-05-08 | No | No | Current |
| 46708-682-03 | 46708068203 | 1 BOTTLE, PUMP in 1 PACKAGE (46708-682-03) / 2 g in 1 BOTTLE, PUMP | | 2025-05-08 | No | No | Current |