NDC 11523-0082
Lotrimin Ultra
Butenafine Hydrochloride
Lotrimin Ultra is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Bayer Healthcare Llc.. The primary component is Butenafine Hydrochloride.
| Product ID | 11523-0082_d39504d0-b01f-bee2-e053-2995a90a7cc8 |
| NDC | 11523-0082 |
| Product Type | Human Otc Drug |
| Proprietary Name | Lotrimin Ultra |
| Generic Name | Butenafine Hydrochloride |
| Dosage Form | Cream |
| Route of Administration | TOPICAL |
| Marketing Start Date | 2021-12-20 |
| Marketing Category | NDA / |
| Application Number | NDA021307 |
| Labeler Name | Bayer Healthcare LLC. |
| Substance Name | BUTENAFINE HYDROCHLORIDE |
| Active Ingredient Strength | 1 g/100g |
| NDC Exclude Flag | N |
| Listing Certified Through | 2022-12-31 |
Packaging
NDC 11523-0082-1
1 TUBE, WITH APPLICATOR in 1 CARTON (11523-0082-1) > 12 g in 1 TUBE, WITH APPLICATOR
| Marketing Start Date | 2021-12-20 |
| NDC Exclude Flag | N |
| Sample Package? | N |
Drug Details
NDC Crossover Matching brand name "Lotrimin Ultra" or generic name "Butenafine Hydrochloride"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 11523-0082 | Lotrimin Ultra | Butenafine hydrochloride |
| 11523-4338 | Lotrimin Ultra | Butenafine hydrochloride |
| 11523-4339 | Lotrimin Ultra | Butenafine hydrochloride |
| 11523-7154 | Lotrimin Ultra | Butenafine Hydrochloride |
| 0363-2100 | Athletes Foot | Butenafine Hydrochloride |
| 11673-016 | Athletes Foot | Butenafine Hydrochloride |
| 11822-2100 | Athletes Foot | Butenafine Hydrochloride |
| 36800-049 | Athletes Foot | Butenafine Hydrochloride |
| 51672-2100 | Athletes Foot | Butenafine Hydrochloride |
| 69842-986 | Athletes Foot | Butenafine Hydrochloride |
| 37808-013 | Athletes Foot Ultra | Butenafine Hydrochloride |
| 49035-225 | Athletes Foot Ultra | Butenafine Hydrochloride |
| 30142-210 | Butenafine Hydrochloride | Butenafine Hydrochloride |
| 49035-178 | Butenafine Hydrochloride | Butenafine Hydrochloride |
| 69842-989 | Butenafine Hydrochloride 1% | Butenafine Hydrochloride |
| 0363-2101 | Jock Itch | Butenafine Hydrochloride |
| 51672-2101 | Jock Itch | Butenafine Hydrochloride |
| 11523-7155 | Lotrimin Ultra Jock Itch | Butenafine Hydrochloride |
| 0378-6151 | MENTAX | butenafine hydrochloride |
Trademark Results [Lotrimin Ultra]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LOTRIMIN ULTRA 76296245 2670158 Live/Registered |
BAYER HEALTHCARE LLC 2001-08-06 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.