FDA.reportPublic FDA data

Lotrimin

Product NDC
11523-6549
11-digit product format
115236549
Labeler code
11523
Product ID
11523-6549_45370735-3f9e-a7f8-e063-6294a90aa0c6
Type
HUMAN OTC DRUG
Nonproprietary name
Clotrimazole
Dosage form
CREAM
Route
TOPICAL
Labeler
Bayer HealthCare LLC.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2009-01-02
Substance
CLOTRIMAZOLE
Active strength
10 mg/g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Lotrimin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOTRIMAZOLE10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G07GZ97H65Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
261159Internal RxNorm lookup
309367Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b584e17f-ed43-43bd-b643-dfa48edd78c6Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-6549-1Lotrimin12 g in 1 TUBECREAM1211
11523-6549-1Lotrimin1 in 1 CARTONCREAM111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11523-6549-1GM - Gram11523-6549045b5150-8690-4812-9bc2-270671b085b612019-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLOTRIMAZOLEACTIVE INGREDIENTG07GZ97H65LOTRIMIN (CLOTRIMAZOLE) CREAM [BAYER HEALTHCARE LLC]2
CLOTRIMAZOLEACTIVE MOIETYG07GZ97H65LOTRIMIN (CLOTRIMAZOLE) CREAM [BAYER HEALTHCARE LLC]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHLOTRIMIN (CLOTRIMAZOLE) CREAM [BAYER HEALTHCARE LLC]2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNLOTRIMIN (CLOTRIMAZOLE) CREAM [BAYER HEALTHCARE LLC]2
CETYL ESTERS WAXINACTIVE INGREDIENTD072FFP9GULOTRIMIN (CLOTRIMAZOLE) CREAM [BAYER HEALTHCARE LLC]2
OCTYLDODECANOLINACTIVE INGREDIENT461N1O614YLOTRIMIN (CLOTRIMAZOLE) CREAM [BAYER HEALTHCARE LLC]2
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MLOTRIMIN (CLOTRIMAZOLE) CREAM [BAYER HEALTHCARE LLC]2
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XLOTRIMIN (CLOTRIMAZOLE) CREAM [BAYER HEALTHCARE LLC]2
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YLOTRIMIN (CLOTRIMAZOLE) CREAM [BAYER HEALTHCARE LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RLOTRIMIN (CLOTRIMAZOLE) CREAM [BAYER HEALTHCARE LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-6549LOTRIMIN (CLOTRIMAZOLE) CREAM [BAYER HEALTHCARE LLC.]10Current NDC, Legacy NDC, 2 package rows20241208_b584e17f-ed43-43bd-b643-dfa48edd78c6.zip

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 34 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClotrimazoleCLOTRIMAZOLEAvPAK3ca3b475-7b69-442a-e063-6294a90a7b3f2025-08-18WarningsExact identifier
application number: M005
Formula 3TOLNAFTATEThe Tetra Corporation0895274b-a09d-4264-a43f-852e44eb31632025-08-18WarningsExact identifier
application number: M005
Formula 7 - The SolutionTOLNAFTATEThe Tetra Corporation18619649-7f79-4b6e-8b7c-69d70365d5572025-08-18WarningsExact identifier
application number: M005
GlyCylicSALICYLIC ACIDThe Tetra Corporation501d3ba9-ba42-4c1c-983b-492adaee039d2025-08-18WarningsExact identifier
application number: M005
SupreH Ringworm Treatment BalmSUPREH RINGWORM TREATMENT BALMShenzhen Xinxin Yunhai Technology Co., Ltd.3c77222b-d92e-84b0-e063-6294a90aadd72025-08-16WarningsExact identifier
application number: M005
OetMoe Antifungal SolutionOETMOE ANTIFUNGAL SOLUTIONShenzhen Earth Surface Trading Co., Ltd.3c26d917-4186-6f02-e063-6394a90a99f62025-08-12WarningsExact identifier
application number: M005
Cureforte Anti Fungal Foot CareANTI FUNGAL FOOT CARE DROPSSTEEL CITY HEALTH PRIVATE LIMITED39f762a6-9d0c-8ded-e063-6394a90a36592025-08-11WarningsExact identifier
application number: M005
Derman Antifungal Powder TolnaftateTOLNAFTATETaisho Pharmaceutical California Inc.3a854765-740c-4719-8abf-4b3f932cdee02025-08-07WarningsExact identifier
application number: M005
Derman antifungal creamTOLNAFTATETaisho Pharmaceutical California Inc.15d9b3c9-01af-4083-a1bc-014505d8798d2025-08-07WarningsExact identifier
application number: M005
Maximum Strength Antifungal LiquidTOLNAFTATEHudson Health LLC24b22794-f9f8-6f32-e063-6394a90aec982025-08-07WarningsExact identifier
application number: M005
Toe Area TreatmentTOLNAFTATECVS17681cc8-fbb1-a0cf-e063-6294a90add182025-08-07WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATEFamily Dollar Services, Inc178e7b3f-949f-3f51-e063-6294a90a93952025-08-07WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATELEADER/Cardinal Health 110, Inc.17695563-3765-74cb-e063-6294a90a61202025-08-07WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATETarget Corporation1dff278f-47bc-459a-e063-6394a90a26462025-08-07WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATETopCo Associates19c268a1-7b2e-63c9-e063-6394a90acddc2025-08-07WarningsExact identifier
application number: M005
Antifungal Liquid Maximum StrengthTOLNAFTATEWalgreens Company137eabb7-cb4f-1631-e063-6294a90ab8472025-08-07WarningsExact identifier
application number: M005
WCTNGO Fungal Nail Treatment SwabsTOLNAFTATE,UNDECYLENIC ACIDShenzhen Boyimei Technology Co., Ltd.3bad0d73-b33d-b962-e063-6294a90a7ba72025-08-06WarningsExact identifier
application number: M005
ONIADBA Nail Fungus Treatment PenTOLNAFTATE,UNDECYLENIC ACIDShenzhen Boyimei Technology Co., Ltd.3bad19f1-d5b3-c5de-e063-6294a90a0c032025-08-06WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATEPremier Brands of America Inc2644ba07-aaee-6402-e063-6394a90a28272025-08-06WarningsExact identifier
application number: M005
Anti- Fungal Miconazole NitrateMICONAZOLE NITRATEPremier Brands of America Inc.f186bdc1-db6c-0fab-e053-2995a90a7c582025-08-06WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309367clotrimazole 1 % Topical CreamPSNb584e17f-ed43-43bd-b643-dfa48edd78c611
261159LOTRIMIN 1 % Topical CreamPSNb584e17f-ed43-43bd-b643-dfa48edd78c611
261159clotrimazole 10 MG/ML Topical Cream [Lotrimin]SBDb584e17f-ed43-43bd-b643-dfa48edd78c611
309367clotrimazole 10 MG/ML Topical CreamSCDb584e17f-ed43-43bd-b643-dfa48edd78c611
309367clotrimazole 1 % Topical CreamSYb584e17f-ed43-43bd-b643-dfa48edd78c611
261159Lotrimin 1 % Topical CreamSYb584e17f-ed43-43bd-b643-dfa48edd78c611

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11523-6549-1115236549011 TUBE in 1 CARTON (11523-6549-1) / 12 g in 1 TUBE1 tube2009-01-020000-00-00NoNoCurrent