Docosanol
- Product NDC
- 55301-112
- 11-digit product format
- 553010112
- Labeler code
- 55301
- Product ID
- 55301-112_e3e1a27f-ca0b-4378-bdd9-b7af32a5d357
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Docosanol
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- AAFES/Your Military Exchanges
- Application
- ANDA212385
- Marketing category
- ANDA
- Marketing start
- 2023-12-31
- 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 Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55301-112-07 | Docosanol | 1 in 1 PACKAGE | CREAM | 1 | | 3 |
| 55301-112-07 | Docosanol | 2 g in 1 TUBE | CREAM | 2 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55301-112 | DOCOSANOL CREAM [AAFES/YOUR MILITARY EXCHANGES] | 3 | Current NDC, 2 package rows | 20250309_11272b21-295d-49b3-83bf-5f71899340c5.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 |
|---|
| 55301-112-07 | 55301011207 | 1 TUBE in 1 PACKAGE (55301-112-07) / 2 g in 1 TUBE | 1 tube | 2023-12-31 | No | No | Historical |