Lotrimin Ultra
- Product NDC
- 11523-0082
- 11-digit product format
- 115230082
- Labeler code
- 11523
- Product ID
- 11523-0082_4526ca36-993f-b574-e063-6294a90a8fba
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Butenafine hydrochloride
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Bayer Healthcare LLC.
- Application
- NDA021307
- Marketing category
- NDA
- Marketing start
- 2021-12-20
- Substance
- BUTENAFINE HYDROCHLORIDE
- Active strength
- 1 g/100g
- 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
- Lotrimin Ultra
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BUTENAFINE HYDROCHLORIDE | 1 g/100g |
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 |
|---|
| 11523-0082-1 | Lotrimin Ultra | 20 g in 1 TUBE, WITH APPLICATOR | CREAM | 20 | | 7 |
| 11523-0082-1 | Lotrimin Ultra | 1 in 1 CARTON | CREAM | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 11523-0082 | LOTRIMIN ULTRA (BUTENAFINE HYDROCHLORIDE) CREAM [BAYER HEALTHCARE LLC.] | 6 | Current NDC, Legacy NDC, 2 package rows | 20241208_d11dfdf6-9b36-03bc-e053-2995a90a0bc3.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 11523-0082-1 | 11523008201 | 1 TUBE, WITH APPLICATOR in 1 CARTON (11523-0082-1) / 20 g in 1 TUBE, WITH APPLICATOR | 2021-12-20 | 0000-00-00 | No | No | Current |