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United States · US · US:11523-4338_45370c88-0d4f-d4df-e063-6394a90a6eb7
Lotrimin Ultra
Orange BookUNIISPLATC D01AE23
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBayer Healthcare LLC.
CountryUS (United States)
ATC codeD01AE23
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1111523433811 TUBE in 1 CARTON (11523-4338-1) / 12 g in 1 TUBE
- ndc1111523433821 TUBE in 1 CARTON (11523-4338-2) / 15 g in 1 TUBE
- ndc1111523433841 TUBE in 1 CARTON (11523-4338-4) / 30 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
R8XA2029ZI
BUTENAFINE HYDROCHLORIDE
RxCUI 236558
Orange Book
N021307
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "R8XA2029ZI",
"rxcui": "236558",
"inchikey": "LJBSAUIFGPSHCN-UHFFFAOYSA-N",
"display_name": "BUTENAFINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "TOPICAL",
"spl_meta": {
"cebd222c-074f-443c-bd37-612114b27bbd": {
"match": "brand_token",
"title": "LOTRIMIN ANTIFUNGAL (MICONAZOLE NITRATE) POWDER [BAYER HEALTHCARE LLC.]",
"spl_version": "10",
"published_date": "2026-01-19"
}
},
"productid": "11523-4338_45370c88-0d4f-d4df-e063-6394a90a6eb7",
"productndc": "11523-4338",
"dosage_form": "CREAM",
"orange_book": {
"appl_no": "021307",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "1%",
"product_no": "001",
"approval_date": "Dec 7, 2001"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "BUTENAFINE HYDROCHLORIDE",
"proprietary_name": "Lotrimin Ultra",
"active_ingred_unit": "g/100g",
"application_number": "NDA021307",
"marketing_category": "NDA",
"nonproprietary_name": "Butenafine hydrochloride",
"start_marketing_date": "20020222",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code D01AE23.
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