Butenafine Hydrochloride
- Product NDC
- 79481-0086
- 11-digit product format
- 794810086
- Labeler code
- 79481
- Product ID
- 79481-0086_39070e62-eb92-10ca-e063-6394a90a7564
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Butenafine Hydrochloride
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- MEIJER DISTRIBUTION INC
- Application
- ANDA205181
- Marketing category
- ANDA
- Marketing start
- 2023-11-30
- Substance
- BUTENAFINE HYDROCHLORIDE
- Active strength
- 10 mg/g
- Pharmacologic classes
- Benzylamine Antifungal [EPC], Benzylamines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Butenafine Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BUTENAFINE HYDROCHLORIDE | 10 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | R8XA2029ZI |
| Rxcui | 1298448 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 79481-0086-1 | Butenafine Hydrochloride | 1 in 1 CARTON | CREAM | 1 | | 5 |
| 79481-0086-1 | Butenafine Hydrochloride | 30 g in 1 TUBE | CREAM | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 79481-0086 | BUTENAFINE HYDROCHLORIDE CREAM [MEIJER DISTRIBUTION INC] | 4 | Current NDC, 2 package rows | 20250213_4e88068b-1449-43b4-9c7c-4ad8e877459b.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 |
|---|
| 79481-0086-1 | 79481008601 | 1 TUBE in 1 CARTON (79481-0086-1) / 30 g in 1 TUBE | 1 tube | 2023-11-30 | No | No | Current |