FDA.reportPublic FDA data

Lotrimin

Product NDC
11523-0963
11-digit product format
115230963
Labeler code
11523
Product ID
11523-0963_4526ec9e-c017-25d1-e063-6294a90a6ebb
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
2002-02-01
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
da948ef3-3709-4bfc-9d17-f6f1ea325343Available 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
11523-0963-1Lotrimin30 g in 1 TUBECREAM3012
11523-0963-1Lotrimin1 in 1 CARTONCREAM112
11523-0963-2Lotrimin1 in 1 CARTONCREAM112
11523-0963-2Lotrimin15 g in 1 TUBECREAM1512
11523-0963-5Lotrimin12 g in 1 TUBECREAM1212
11523-0963-5Lotrimin1 in 1 CARTONCREAM112
11523-0963-7Lotrimin24 g in 1 TUBECREAM2412
11523-0963-7Lotrimin1 in 1 CARTONCREAM112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11523-0963-1GM - Gram11523-0963cf81c159-c432-4063-a63b-d805da70e37512016-05-16
11523-0963-2GM - Gram11523-09636f3118c6-60d0-4e76-bf08-c9c1b611d86612022-06-06
11523-0963-5GM - Gram11523-0963127ee0c5-76d1-4063-b99d-ef37d84ba26112012-07-24
11523-0963-7GM - Gram11523-0963f4b2f9ce-4aa9-4ee5-9b41-ad103b5ffe0e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLOTRIMAZOLEACTIVE INGREDIENTG07GZ97H65LOTRIMIN (CLOTRIMAZOLE) CREAM [BAYER HEALTHCARE LLC]3
CLOTRIMAZOLEACTIVE MOIETYG07GZ97H65LOTRIMIN (CLOTRIMAZOLE) CREAM [BAYER HEALTHCARE LLC]3
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHLOTRIMIN (CLOTRIMAZOLE) CREAM [BAYER HEALTHCARE LLC]3
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNLOTRIMIN (CLOTRIMAZOLE) CREAM [BAYER HEALTHCARE LLC]3
CETYL ESTERS WAXINACTIVE INGREDIENTD072FFP9GULOTRIMIN (CLOTRIMAZOLE) CREAM [BAYER HEALTHCARE LLC]3
OCTYLDODECANOLINACTIVE INGREDIENT461N1O614YLOTRIMIN (CLOTRIMAZOLE) CREAM [BAYER HEALTHCARE LLC]3
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MLOTRIMIN (CLOTRIMAZOLE) CREAM [BAYER HEALTHCARE LLC]3
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XLOTRIMIN (CLOTRIMAZOLE) CREAM [BAYER HEALTHCARE LLC]3
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YLOTRIMIN (CLOTRIMAZOLE) CREAM [BAYER HEALTHCARE LLC]3
WATERINACTIVE INGREDIENT059QF0KO0RLOTRIMIN (CLOTRIMAZOLE) CREAM [BAYER HEALTHCARE LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-0963LOTRIMIN (CLOTRIMAZOLE) CREAM [BAYER HEALTHCARE LLC]11Current NDC, Legacy NDC, 8 package rows20241208_da948ef3-3709-4bfc-9d17-f6f1ea325343.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 13 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medi-First Clotrimazole 1% ANTIFUNGAL CreamCLOTRIMAZOLEUnifirst First Aid Corporation522eeb91-8378-32f4-e063-6394a90aff432026-05-20WarningsExact identifier
application number: M005
Kopa Haiku Antifungal CreamMICONAZOLE NITRATE 2%Trovina Co. Ltd47cf1251-5965-045a-e063-6394a90ab04f2026-05-19WarningsExact identifier
application number: M005
APUREE PRO Nailtific Maximum Strength Antifungal PatchesAPUREE PRO NAILTIFIC MAXIMUM STRENGTH ANTIFUNGAL PATCHESGuangzhou Meixi Biotechnology Co., Ltd.5218bd5d-53b4-107f-e063-6394a90ae7692026-05-18Exact identifier
application number: M005
APUREE Pro Nailtific Maximum Strength Dual-Action Antifungal PenAPUREE PRO NAILTIFIC MAXIMUM STRENGTH DUAL-ACTION ANTIFUNGAL PENGuangzhou Meixi Biotechnology Co., Ltd.521a0e40-a218-fabb-e063-6294a90ae9a22026-05-18WarningsExact identifier
application number: M005
Beukow Antifungal PenUNDECYLENIC ACID 25% ANTIFUNGAL PENJiangxi Yudexi Pharmaceutical Co., LTD511d1edf-dfda-477c-e063-6294a90aa4232026-05-17WarningsExact identifier
application number: M005
Nail Repair PenNAIL REPAIR PENShenzhen Earth Surface Trading Co., Ltd.520f6514-6660-d6a8-e063-6394a90adf822026-05-17WarningsExact identifier
application number: M005
Fungicure IntensiveCLOTRIMAZOLEKobayashi Healthcare International, Inc.1f1b413f-278e-434f-8590-4cf731663f5c2026-05-15WarningsExact identifier
application number: M005
Dr Scholls Fungal Nail Clear and Cure Tolnaftate AntifungalTOLNAFTATEScholl's Wellness Company LLC8abd6d8e-c69e-4374-ace8-d42b2d3e171e2026-05-14WarningsExact identifier
application number: M005
Dr.Scholl s Odor X Athlete s FootTOLNAFTATEScholl's Wellness Company LLC0e864882-5e00-491e-a008-0762c131637a2026-05-14WarningsExact identifier
application number: M005
Athletes FootTOLNAFTATERugby Laboratories50c46cf5-3e64-9e0f-e063-6294a90a23172026-05-14WarningsExact identifier
application number: M005
TOSSOYA Rainforest SecretGuard Antibacterial Quick-Cleanse WipesTOSSOYA RAINFOREST SECRETGUARD ANTIBACTERIAL QUICK-CLEANSE WIPESShenzhen Shierjie Biological Engineering Co., LTD3d53463d-8d8e-9030-e063-6294a90ab4542026-05-13WarningsExact identifier
application number: M005
Anti-Fungal PowderMICONAZOLE NITRATECVS Pharmacy1651bdd7-ab15-7a2d-e063-6294a90a8b912026-05-11WarningsExact identifier
application number: M005
Lightning X Hand CleanserETHYL ALCOHOLNantong Health & Beyond Hygienic Products Inc.51861f1e-8961-e876-e063-6394a90a2fd02026-05-11WarningsExact identifier
application number: M005
APUREE Nailtific Maximum Strength Antifungal Patches PROAPUREE NAILTIFIC MAXIMUM STRENGTH ANTIFUNGAL PATCHES PROGuangzhou Meixi Biotechnology Co., Ltd5189ebc5-8ee5-1b2c-e063-6294a90af5c82026-05-11WarningsExact identifier
application number: M005
APUREE Nailtific Maximum Strength Dual-Action Antifungal Pen ProAPUREE NAILTIFIC MAXIMUM STRENGTH DUAL-ACTION ANTIFUNGAL PEN PROGuangzhou Meixi Biotechnology Co., Ltd.518abf2b-6ac8-ab9b-e063-6294a90ae6932026-05-11WarningsExact identifier
application number: M005
CLOTRIMAZOLECLOTRIMAZOLERugby Laboratories, Inc.2c60e631-5930-4420-886d-eb1990c720b62026-05-11WarningsExact identifier
application number: M005
TolfyraTOLNAFTATEOncora Pharma, LLCb28ee9f2-fc45-4336-b374-be7aa51d44e92026-05-11WarningsExact identifier
application number: M005
clotrimazoleCLOTRIMAZOLEA-S Medication Solutionsc0f58a0d-a304-41f9-bbdf-c2e488230cf02026-05-11WarningsExact identifier
application number: M005
Inlifay ANTIFUNGALTOLNAFTATEGuangdong Aimu Biological Technology Co., Ltd5148b838-d26e-cf66-e063-6394a90ae4692026-05-09WarningsExact identifier
application number: M005
HuiPoLii NAIL PFLASTERTOLNAFTATE 1% NAIL PFLASTERJiangxi Yudexi Pharmaceutical Co., LTD514b1c2d-cecb-30a2-e063-6394a90af2662026-05-08WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309367clotrimazole 1 % Topical CreamPSNda948ef3-3709-4bfc-9d17-f6f1ea32534312
261159LOTRIMIN 1 % Topical CreamPSNda948ef3-3709-4bfc-9d17-f6f1ea32534312
261159clotrimazole 10 MG/ML Topical Cream [Lotrimin]SBDda948ef3-3709-4bfc-9d17-f6f1ea32534312
309367clotrimazole 10 MG/ML Topical CreamSCDda948ef3-3709-4bfc-9d17-f6f1ea32534312
309367clotrimazole 1 % Topical CreamSYda948ef3-3709-4bfc-9d17-f6f1ea32534312
261159Lotrimin 1 % Topical CreamSYda948ef3-3709-4bfc-9d17-f6f1ea32534312

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11523-0963-1115230963011 TUBE in 1 CARTON (11523-0963-1) / 30 g in 1 TUBE1 tube2002-02-010000-00-00NoNoCurrent
11523-0963-2115230963021 TUBE in 1 CARTON (11523-0963-2) / 15 g in 1 TUBE1 tube2002-02-010000-00-00NoNoCurrent
11523-0963-5115230963051 TUBE in 1 CARTON (11523-0963-5) / 12 g in 1 TUBE1 tube2002-02-010000-00-00NoNoCurrent
11523-0963-7115230963071 TUBE in 1 CARTON (11523-0963-7) / 24 g in 1 TUBE1 tube2002-02-010000-00-00NoNoCurrent