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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| R8XA2029ZI | BUTENAFINE HYDROCHLORIDE | 101827-46-7 | BUTENAFINE HYDROCHLORIDE |
Packages
| 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 | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Butenafine Hydrochloride | MEIJER DISTRIBUTION INC | Sun Pharma Canada Inc. | 2025-07-03 | HUMAN OTC DRUG LABEL | 5 |