warnings
Warnings For external use only
Lotrimin Ultra
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- Brand name
- Lotrimin Ultra
- Generic name
- BUTENAFINE HYDROCHLORIDE
- Manufacturer
- Bayer Healthcare LLC.
- Product type
- HUMAN OTC DRUG
- SPL set ID
- d11dfdf6-9b36-03bc-e053-2995a90a0bc3
- SPL ID
- 4526ca36-993f-b574-e063-6294a90a8fba
- Version
- 7
- Effective date
- 2025-12-04
- Source export date
- 2026-09-28
- Source partition
- 11
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:19:08
| Harmonized routes |
|---|
| TOPICAL |
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application applno | NDA | 021307 | derived:openfda.application_number |
| application number | NDA021307 | openfda.application_number | |
| brand name | Lotrimin Ultra | openfda.brand_name | |
| generic name | BUTENAFINE HYDROCHLORIDE | openfda.generic_name | |
| manufacturer name | Bayer Healthcare LLC. | openfda.manufacturer_name | |
| ndc | package | 11523-0082-1 | openfda.package_ndc |
| ndc | product | 11523-0082 | openfda.product_ndc |
| ndc11 | package | 11523008201 | derived:openfda.package_ndc |
| rxcui | 1298448 | openfda.rxcui | |
| spl id | 4526ca36-993f-b574-e063-6294a90a8fba | id | |
| spl set id | d11dfdf6-9b36-03bc-e053-2995a90a0bc3 | set_id | |
| unii | R8XA2029ZI | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.