Butenafine Hydrochloride
- Product NDC
- 49035-178
- 11-digit product format
- 490350178
- Labeler code
- 49035
- Product ID
- 49035-178_3907bb0c-b1fe-a7e5-e063-6394a90ad6d8
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Butenafine Hydrochloride
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Wal-Mart Stores Inc
- Application
- ANDA205181
- Marketing category
- ANDA
- Marketing start
- 2017-11-16
- 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
- Brand name suffix
- Jock Itch
- 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 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 49035-178-08 | Butenafine Hydrochloride Jock Itch | 1 in 1 CARTON | CREAM | 1 | | 2 |
| 49035-178-08 | Butenafine Hydrochloride Jock Itch | 12 g in 1 TUBE | CREAM | 12 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49035-178 | BUTENAFINE HYDROCHLORIDE JOCK ITCH (BUTENAFINE HYDROCHLORIDE) CREAM [WAL-MART STORES INC] | 1 | Current NDC, Legacy NDC, 2 package rows | 20190109_be9a411c-55d7-4db5-a420-30013efbbc24.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 |
|---|
| 49035-178-08 | 49035017808 | 1 TUBE in 1 CARTON (49035-178-08) / 12 g in 1 TUBE | 1 tube | 2018-12-14 | 0000-00-00 | No | No | Current |