ABREVA
- Product NDC
- 0135-0300
- 11-digit product format
- 001350300
- Labeler code
- 0135
- Product ID
- 0135-0300_1b529b4c-e36d-5070-e063-6294a90ac5c8
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- docosanol
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Haleon US Holdings LLC
- Application
- ANDA208754
- Marketing category
- ANDA
- Marketing start
- 2022-03-25
- 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
- ABREVA
- 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, 855205 |
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0135-0300 | ABREVA (DOCOSANOL) CREAM [HALEON US HOLDINGS LLC] | 5 | Current NDC, Legacy NDC, 4 package rows | 20240621_bf02c8c5-af60-41f1-a202-38a97491a720.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 |
|---|
| 0135-0300-01 | 00135030001 | 1 TUBE in 1 PACKAGE (0135-0300-01) / 2 g in 1 TUBE | 1 tube | 2022-03-25 | 0000-00-00 | No | No | Current |
| 0135-0300-02 | 00135030002 | 2 TUBE in 1 PACKAGE (0135-0300-02) / 2 g in 1 TUBE | 2 tube | 2022-04-25 | 0000-00-00 | No | No | Current |