FDA.reportPublic FDA data

NDC 11523-4338-02 - 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
11523-4338-02
Package NDCs from labels
11523-4338-1, 11523-4338-2, 11523-4338-4, 11523-4338-02
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 1 of 50 · 990 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lanolin, PetrolatumLANOLIN, PETROLATUMCVS Pharmacy, Inc.606f65a8-08fd-4ab6-9d68-03ddf662bdf02026-09-09Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Advanced HealingPETROLATUMWalgreen Co.22bd8e87-965c-466b-bb9b-7d4753e500bc2026-09-09Warnings, Adverse reactionsExact identifier
unii: 4T6H12BN9U
Leader Eye Drops Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDECardinal Healthaee4bbe2-4f11-4c54-be8b-df48b3ba4f3a2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
Drs. Pharmacy baby healingPETROLATUMOL PHARMA TECH, LLC Drs PHARMACY5b14ffa0-9486-a7fe-e063-6394a90ab3ed2026-09-09WarningsExact identifier
unii: 4T6H12BN9U
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMRite Aid Corporation407c78ca-6fee-4ed6-b61b-711ec049c86e2026-09-09WarningsExact identifier
unii: 4T6H12BN9U
unii: PDC6A3C0OX
Intense Therapy Lip Balm Pineapple MintSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLC0862534c-5f48-4f67-a3b8-0876a667556f2026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Intense Therapy Lip Balm SPF25, Shea Butter and Vitamin ELIP BALM SPF25Jack Black, LLC88e8752d-1fbf-4e28-b79d-7c05ecdce8422026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Jack Black Intense Lip Therapy SPF25, Natural Mint and Shea ButterLIP BALM SUNSCREENJack Black, LLCe8730127-2d8d-4b80-ab90-d2f136d9e5162026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Jack Black Intense Therapy Lip Balm SPF25, Grapefruit and GingerLIP BALM SUNSCREENJack Black, LLCd961d22a-2125-41e9-94a3-5b53d12b320f2026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Jack Black Intense Lip Therapy SPF25, Black Tea and BlackberryLIP BALM SUNSCREENJack Black, LLC172a70bc-8a09-4258-b9bf-cf3c67ff76132026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Clear Eyes NighttimeGLYCERINPrestige Brands Holdings, Inc.af75e2f7-81dd-43e0-a390-b52bbfbebf622026-09-08WarningsExact identifier
unii: PDC6A3C0OX
Intense Therapy Lip Balm Asian PearSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLCacace707-6671-4818-86f2-d9813792157a2026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Intense Therapy Lip Balm Basil LemonSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLC277cb44d-608a-4ffc-a2a5-ac57d33d214c2026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Intense Therapy Lip Balm Black CherrySUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLC8f413bd6-258c-4c3c-89d1-369938c857202026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Intense Therapy Lip Balm Cucumber LimeSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLC5f15bee9-9bf4-4f27-a6b5-4205deb625f62026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Intense Therapy Lip Balm Winter MelonSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLCe7792b4e-a6d2-487e-ba28-27b68e6d7e272026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Jack Black Intense Therapy Lip Balm Vanilla BourbonAVOBENZONE, OCTINOXATE LIP BALM SUNSCREENJack Black, LLC517040d1-e6ed-40ca-a46f-2f75403dbc3c2026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Intense Therapy Lip Balm Mango and MandarinSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLC8c55d1cd-cdd6-468b-8a17-b940c62101162026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Jack Black Intensive Therapy Lip Balm Mango Chili LimeAVOBENZONE, OCTINOXATE LIP BALM SUNSCREENJack Black, LLC51349d57-b14d-4798-8d68-03fbe3713d1e2026-09-08WarningsExact identifier
unii: 4T6H12BN9U
Jack Black Intense Thearpy Lip Balm SPF25, Lemon and Shea ButterLIP BALM SUNSCREENJack Black, LLC518cb17a-fdaa-4a60-93fc-708305366eb82026-09-08WarningsExact identifier
unii: 4T6H12BN9U

Reported adverse events (FAERS/openFDA)#

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