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 8 of 49 · 977 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Moisture OysterGLYCERINMoisture Oyster Inc4e45317a-437f-4d88-e063-6294a90a98d02026-03-30WarningsExact identifier
unii: PDC6A3C0OX
Aveeno Skin Relief HealingGLYCERINKenvue Brands LLC345fdde5-700b-7103-e063-6394a90a0e3e2026-03-27WarningsExact identifier
unii: PDC6A3C0OX
Critic Aid ClearPETROLATUMColoplast Corp0b6da97e-519b-4579-9895-f4ede5c48b472026-03-27WarningsExact identifier
unii: 4T6H12BN9U
Baza ClearPETROLATUMColoplast Corp69d9f456-1a35-4146-8366-c0285648a1722026-03-27WarningsExact identifier
unii: 4T6H12BN9U
Vitamin A DLANOLIN, PETROLATUMTopco Associates LLC5126fdf6-5df5-474b-bc0d-3a82dea61abb2026-03-26Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Advanced HealingPETROLATUMAmazon.com Services LLCcdf1bd12-ac59-4f06-be0f-ef6eb3caeeff2026-03-26Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Crocodile Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Crocodile Tears LLC4df29336-ea0c-0484-e063-6294a90a685a2026-03-26WarningsExact identifier
unii: PDC6A3C0OX
Artificial Tears Lubricant Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400KC Pharmaceuticals, Inc4de5c844-85ca-ff9f-e063-6394a90ac12c2026-03-25WarningsExact identifier
unii: PDC6A3C0OX
Lemon GlycerinGLYCERINDynarex Corporation99fc00ea-9d55-0380-e053-2995a90a2c0b2026-03-24WarningsExact identifier
unii: PDC6A3C0OX
D-CerinMOISTURIZERDynarex Corporation7ea47a7e-12af-9290-e053-2a91aa0a065f2026-03-24WarningsExact identifier
unii: 4T6H12BN9U
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
VaselineHEALING JELLYConopco Inc. d/b/a Unileverbd4418b7-c6aa-5e71-e053-2995a90a4cc42026-03-16WarningsExact identifier
unii: 4T6H12BN9U
Vaseline Intensive Care Deep MoisturePETROLEUMConopco Inc. d/b/a Unilever65cec560-25c7-4076-a33d-a3dd534ff85b2026-03-16WarningsExact identifier
unii: 4T6H12BN9U
Panama Jack SPF 45 Vanilla Lip BalmAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, PETROLATUMPanama Jack71bb5177-20af-4aee-ab02-6687c51fe0a12026-03-14WarningsExact identifier
unii: 4T6H12BN9U
Optimel Manuka Dry Eye DropsGLYCERINMelcare Biomedical Pty Ltd88c5e2f0-9f7e-62d1-e053-2995a90a90142026-03-11WarningsExact identifier
unii: PDC6A3C0OX
Optimel Manuka Forte Eye GelGLYCERINMelcare Biomedical Pty Ltd8e0ed6e8-51fc-7c5b-e053-2a95a90a35a92026-03-11WarningsExact identifier
unii: PDC6A3C0OX
Panama Jack SPF 45 Mango Lip BalmAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, PETROLATUMPanama Jackbd0f6577-9638-4319-b759-348f357ce3972026-03-11WarningsExact identifier
unii: 4T6H12BN9U
Panama Jack SPF 45 Dreamsicle Lip BalmAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, PETROLATUMPanama Jack34e89add-ca63-4b66-bdf5-d47403c917702026-03-11WarningsExact identifier
unii: 4T6H12BN9U
Panama Jack SPF 45 Tropical Lip BalmAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, PETROLATUMPanama Jacka271ec3c-e0ea-4100-9a56-b127bbfef3472026-03-11WarningsExact identifier
unii: 4T6H12BN9U

Reported adverse events (FAERS/openFDA)#

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