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 15 of 49 · 969 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Miconazole NitrateATHLETES FOOT POWDER SPRAY TALC FREEWal-Mart Stores, Incaf4d4e9e-8678-3a80-e053-2995a90a677f2026-04-22WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL LIQUID SPRAYWal-Mart Stores, Incaf4ebb3b-041e-30dd-e053-2995a90a8d2d2026-04-22WarningsExact identifier
application number: M005
TolnafateTOLNAFTATE POWDER SPRAYWal-Mart Stores, Incaf4dd045-ca51-42b9-e053-2a95a90a03272026-04-22WarningsExact identifier
application number: M005
4ozMICONAZOLENabrace LLC4f912a20-e0f7-23c1-e063-6294a90a55d62026-04-18WarningsExact identifier
application number: M005
Nabrace Wipes for Ringworm, Jockitch and Athlete FeetNABRACE WIPES FOR RINGWORM, JOCKITCH AND ATHLETE FEETNabrace LLC4fc3ddc8-08a2-ae50-e063-6294a90a1e072026-04-18WarningsExact identifier
application number: M005
SimplyVital Antifungal ClotrimazoleCLOTRIMAZOLEAlpha Plants Inc44881106-3ab4-4103-9c48-1da435ab5b132026-04-16WarningsExact identifier
application number: M005
medicatedMICONAZOLENabrace LLC4f90d8ad-33d9-0043-e063-6394a90a44662026-04-16WarningsExact identifier
application number: M005
Ingrown Nail TreatmentJALAWEF INGROWN NAIL TREATMENTConsilii LLC1ac2d7fc-1806-7925-e063-6294a90ad3b52026-04-15WarningsExact identifier
application number: M005
RDVHDLW Extra Strength NAIL REPAIR PENTOLNAFTATE, UNDECYLENIC ACIDShenzhen Joyuflsh Technology Co.,Ltd.4f68796c-11e1-e5f7-e063-6394a90adeb12026-04-14WarningsExact identifier
application number: M005
ProBliva Psoriasis Scalp .spray.SALICYLIC ACID 3%CAVTECH HOLDING LLC4f695604-51c5-c1b7-e063-6294a90ab5ae2026-04-14WarningsExact identifier
application number: M005
OSIMOON Fungal Nail TreatmentFUNGAL NAIL TREATMENTGuangzhou Jingliang Cosmetics Co., Ltd.4f7817db-cd71-fba9-e063-6294a90a9cdf2026-04-14WarningsExact identifier
application number: M005
Quali Life ANTIFUNGAL PERSIMMONTOLNAFTATEGuangdong Aimu Biological Technology Co., Ltd4f520058-3b81-574e-e063-6294a90a2eae2026-04-13WarningsExact identifier
application number: M005
Quali Life ANTIFUNGAL CHARCOALTOLNAFTATEGuangdong Aimu Biological Technology Co., Ltd4f538041-e2f1-4a5f-e063-6294a90a54cf2026-04-13WarningsExact identifier
application number: M005
RoyceDerm tinea ANTIFUNGAL .cream. and .soap.CREAM AND SOAPRoyceDerm LLC4f4ef2d0-98fa-e791-e063-6394a90a70452026-04-12WarningsExact identifier
application number: M005
Nailtific Daytime Treatment Antifungal Pen RefillNAILTIFIC DAYTIME TREATMENT ANTIFUNGAL PEN REFILLGuangzhou Meixi Biotechnology Co., Ltd.4257ee32-0d8f-08d4-e063-6294a90a4a892026-04-11WarningsExact identifier
application number: M005
Nailtific Nighttime Antifungal Renewal Pen RefillTOLNAFTATEGuangzhou Meixi Biotechnology Co., Ltd.42634fc7-d0c7-4813-e063-6294a90a702d2026-04-11WarningsExact identifier
application number: M005
Maximum Strength Antifungal LiquidTOLNAFTATEChain Drug Marketing Association Inc1a4f4d10-6782-ddb4-e063-6294a90ac2062026-04-09WarningsExact identifier
application number: M005
Extra Strength Toenail Renewal SolutionUNDECYLENIC ACID, TOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD4eed68e6-6814-0181-e063-6394a90a888e2026-04-08WarningsExact identifier
application number: M005
TAGOQHIA Extra Strength NAIL REPAIR PENTOLNAFTATE, UNDECYLENIC ACIDGuangzhou Borderless Technology Co., Ltd.4eefbef4-7643-dca4-e063-6394a90a72c12026-04-08WarningsExact identifier
application number: M005
ZYNTHIXUNDECYLENIC ACID SOLUTIONShenzhen Siwei Yijiu Trading Co., Ltd.4ef4a167-f673-efb4-e063-6294a90a30262026-04-08WarningsExact 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