FDA.reportPublic FDA data

NDC 11523-4338-01 - Lotrimin Ultra Athletes Foot

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
11523-4338
Requested NDC
11523-4338-01
Package NDCs from labels
11523-4338-1, 11523-4338-2, 11523-4338-4, 11523-4338-01
Manufacturer
Bayer Healthcare LLC.
Effective date
2025-12-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Lotrimin Ultra ® Athlete's FootBayer Healthcare LLC.2025-12-05HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-4338-1Lotrimin UltraAthletes Foot12 g in 1 TUBECREAM1211
11523-4338-1Lotrimin UltraAthletes Foot1 in 1 CARTONCREAM111
11523-4338-2Lotrimin UltraAthletes Foot15 g in 1 TUBECREAM1511
11523-4338-2Lotrimin UltraAthletes Foot1 in 1 CARTONCREAM111
11523-4338-4Lotrimin UltraAthletes Foot1 in 1 CARTONCREAM111
11523-4338-4Lotrimin UltraAthletes Foot30 g in 1 TUBECREAM3011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-4338LOTRIMIN ULTRA ATHLETES FOOT (BUTENAFINE HYDROCHLORIDE) CREAM [BAYER HEALTHCARE LLC.]10Current NDC, Legacy NDC, 6 package rows20241208_e258c4ac-53ef-4a99-b732-4985f890b938.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11523-4338-1GM - Gram11523-43387b97e907-4d14-497b-8e98-b327a4d2030612017-07-07
11523-4338-4GM - Gram11523-43380fa093bf-8849-46d8-a07e-444260ebd6a012016-04-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Butenafine hydrochlorideACTIVE INGREDIENTR8XA2029ZILOTRIMIN ULTRA ATHLETES FOOT (BUTENAFINE HYDROCHLORIDE) CREAM [MSD CONSUMER CARE INC.]1
ButenafineACTIVE MOIETY91Y494NL0XLOTRIMIN ULTRA ATHLETES FOOT (BUTENAFINE HYDROCHLORIDE) CREAM [MSD CONSUMER CARE INC.]1
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHLOTRIMIN ULTRA ATHLETES FOOT (BUTENAFINE HYDROCHLORIDE) CREAM [MSD CONSUMER CARE INC.]1
ceteth-23INACTIVE INGREDIENT495CTZ441VLOTRIMIN ULTRA ATHLETES FOOT (BUTENAFINE HYDROCHLORIDE) CREAM [MSD CONSUMER CARE INC.]1
cetyl alcoholINACTIVE INGREDIENT936JST6JCNLOTRIMIN ULTRA ATHLETES FOOT (BUTENAFINE HYDROCHLORIDE) CREAM [MSD CONSUMER CARE INC.]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXLOTRIMIN ULTRA ATHLETES FOOT (BUTENAFINE HYDROCHLORIDE) CREAM [MSD CONSUMER CARE INC.]1
petrolatumINACTIVE INGREDIENT4T6H12BN9ULOTRIMIN ULTRA ATHLETES FOOT (BUTENAFINE HYDROCHLORIDE) CREAM [MSD CONSUMER CARE INC.]1
propylene glycol dicaprylateINACTIVE INGREDIENT581437HWX2LOTRIMIN ULTRA ATHLETES FOOT (BUTENAFINE HYDROCHLORIDE) CREAM [MSD CONSUMER CARE INC.]1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EULOTRIMIN ULTRA ATHLETES FOOT (BUTENAFINE HYDROCHLORIDE) CREAM [MSD CONSUMER CARE INC.]1
stearic acidINACTIVE INGREDIENT4ELV7Z65APLOTRIMIN ULTRA ATHLETES FOOT (BUTENAFINE HYDROCHLORIDE) CREAM [MSD CONSUMER CARE INC.]1
trolamineINACTIVE INGREDIENT9O3K93S3TKLOTRIMIN ULTRA ATHLETES FOOT (BUTENAFINE HYDROCHLORIDE) CREAM [MSD CONSUMER CARE INC.]1
waterINACTIVE INGREDIENT059QF0KO0RLOTRIMIN ULTRA ATHLETES FOOT (BUTENAFINE HYDROCHLORIDE) CREAM [MSD CONSUMER CARE INC.]1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 6 of 49 · 977 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ADVANCED HEALINGPETROLATUMRejoice International Corp.532c7e5a-4d05-3bd0-e063-6294a90aee002026-06-01WarningsExact identifier
unii: 4T6H12BN9U
C-More Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINPROFOUND NUTRITION LIMITED78f04ecb-da5e-468c-81fe-70f7c26b76c22026-06-01WarningsExact identifier
unii: PDC6A3C0OX
ADVANCED HEALING BALMPETROLATUMRejoice International Corp.53285d82-3755-ca78-e063-6394a90a50192026-05-31WarningsExact identifier
unii: 4T6H12BN9U
PURE PETROLATUMPETROLATUMVASA COSMETICS PRIVATE LIMITED52efd466-49bd-bbdf-e063-6394a90aa1082026-05-28WarningsExact identifier
unii: 4T6H12BN9U
TheraCare Vitamin A and D plus EPETROLATUMVeridian Healthcare52e0e248-6c04-feb9-e063-6394a90add462026-05-28WarningsExact identifier
unii: 4T6H12BN9U
Peep ClubGLYCERINPeep Club Eyecare Corp.513d1988-2827-28d8-e063-6294a90a8d1f2026-05-28WarningsExact identifier
unii: PDC6A3C0OX
Advanced HealingPETROLATUMCVS Pharamacy, Inc0bd3380e-2284-44a7-b2ef-68c9909627fd2026-05-26Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
RippleGLYCERIN, POVIDONECorneaCare Inc3b5ba197-d501-681e-e063-6294a90aefb52026-05-24WarningsExact identifier
unii: PDC6A3C0OX
Walgreens Adult Glycerin LaxativeGLYCERIN SUPPOSITORYWalgreens5285403b-ab44-21a1-e063-6394a90a9fd02026-05-23WarningsExact identifier
unii: PDC6A3C0OX
Bacteriostatic WaterBACTERIOSTATIC WATERHospira, Inc.87d6e9dc-fe3b-4593-ac9a-d7493d1959c72026-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
CeraVe Developed with Dermatologists Healing Lip BalmPETROLATUML'Oreal USA Products Inc21dc8842-0672-4d46-bcea-b8e3d54c48bf2026-05-20WarningsExact identifier
unii: 4T6H12BN9U
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
REFRESH LACRI-LUBEMINERAL OIL, PETROLATUMAllergan, Inc.d232a44b-516d-4cdf-a4e7-c3a9a50dc7af2026-05-15WarningsExact identifier
unii: 4T6H12BN9U
Cerave Developed with Dermatologists HealingPETROLATUMLOreal USA Products Incde44ac01-ba17-4f97-ac12-9ea348013bde2026-05-14WarningsExact identifier
unii: 4T6H12BN9U
HEMORRHOIDAL WITH LIDOCAINEGLYCERIN, LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE, WHITE PETROLATUMCVS PHARMACY, INC4d870c68-9e72-464e-b0b8-900d0d661e432026-05-14WarningsExact identifier
unii: PDC6A3C0OX
HydratingPETROLATUMAldermed Inc.4aa6a354-e487-4b65-e063-6394a90abbf02026-05-09WarningsExact identifier
unii: 4T6H12BN9U
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM, POTASSIUM SORBATE, RESORCINUM, SALICYLICUM ACIDUM,Energique, Inc.2831d28e-9cf1-4a72-9c6c-bb014d0595582026-05-06WarningsExact identifier
unii: 4T6H12BN9U
unii: PDC6A3C0OX
unii: LKG8494WBH
Multi FlowerAESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOSEnergique, Inc.09c059e7-f748-402c-8447-af5b61169c582026-05-06WarningsExact identifier
unii: 059QF0KO0R
GlycerinGLYCERIN SUPPOSITORIESNeilmed Pharmaceuticals Inc.374a2ca3-ee04-09a7-e063-6394a90ab7602026-05-05WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.