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#

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 41 of 49 · 969 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Forticept Antifungal Foot GelCLOTRIMAZOLELidan, Inc.1b5851fc-ae73-4e54-bb62-3ff928628b972025-03-25WarningsExact identifier
application number: M005
MICONAZOLE Nitrate 2% Cream ANTIFUNGALMICONAZOLE NITRATEPreferred Pharmaceuticals Inc.14d2a661-a490-41ca-b84f-f2be3bc271b42025-03-24WarningsExact identifier
application number: M005
Dermatin AntifungalCLOTRIMAZOLEMelaleuca, Inc.e993fa3b-1d85-46b7-bda5-ed875be74c4e2025-03-20WarningsExact identifier
application number: M005
1% ketoconazoleKETOCONAZOLETAGRID LLC30b75584-3a1e-c125-e063-6294a90acaa72025-03-19WarningsExact identifier
application number: M005
Forticept Antifungal Foot CreamCLOTRIMAZOLELidan, Inc.17abeb4d-b211-4b8c-a9d2-4c7baba2450c2025-03-07WarningsExact identifier
application number: M005
Terramed Just Think Comfort Antifungal Medicated Body WipesTOLNAFTATERida LLC34577389-8e5d-49ab-a208-9c87b6f3cec42025-03-06WarningsExact identifier
application number: M005
Athletes FootMICONAZOLE NITRATERida LLC85e98ef8-75c3-4be1-b59f-40b5312e21372025-03-06WarningsExact identifier
application number: M005
SOUTH BEACH MULTI-PURPOSE NAIL REPAIRUNDECYLENIC ACIDSOUTH BEACH HAIR CARE PROFESIONAL INC2fb0110c-b275-2a17-e063-6394a90a2d302025-03-06WarningsExact identifier
application number: M005
DG Health Athletes FootCLOTRIMAZOLEDolgencorp, Inc.20370b32-21ad-4362-9b46-c6149c9072312025-02-28WarningsExact identifier
application number: M005
Family Wellness Clotrimazole 1 Anti Fungal CreamCLOTRIMAZOLEFamily Dollar Stores, Inc0667dd81-5633-494e-857e-45fa276fe72c2025-02-25WarningsExact identifier
application number: M005
Family Wellness Athletes Foot Tolnaftate 1 CreamTOLNAFTATEFamily Dollar Stores, Incf72b5bcd-8834-4da9-aa74-78992ec2838f2025-02-25WarningsExact identifier
application number: M005
ANTIFUNGAL MEDICATED BODY WASHTOLNAFTATERida LLCe3ebce6f-88ca-4100-ac79-d300f44e48912025-02-25WarningsExact identifier
application number: M005
FUNGINIX AFTOLNAFTATEThe Sisquoc Healthcare Corporationf6cf5315-6678-486c-85b2-d4b3f748600e2025-02-25WarningsExact identifier
application number: M005
FUNGINIX JOCK ITCH TREATMENTTOLNAFTATEThe Sisquoc Healthcare Corporationb2ce1c25-93d5-441f-9b3b-68ae46400c2c2025-02-25WarningsExact identifier
application number: M005
Miconazole NitrateMICONAZOLE NITRATEA-S Medication Solutionsbf131f33-3ab2-4f43-add5-920e78ac36a72025-02-24WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEPreferred Pharmaceuticals Inc.0052992a-819c-4c55-bd88-201a09a3573a2025-02-21WarningsExact identifier
application number: M005
TolnaftateTOLNAFTATESheffield Pharmaceuticals LLCca52af37-c3a2-414c-a24a-a37a929251332025-02-20WarningsExact identifier
application number: M005
Dr Sheffield Athletes FootCLOTRIMAZOLESheffield Pharmaceuticals LLCb8b8e6b2-1022-4592-91ba-3cf94c7cf3182025-02-19WarningsExact identifier
application number: M005
UKVOA Toenail Fungus TreatmentTOLNAFTATE 1% FUNGI NAILJiashen International Trade Limited2e3cde7b-850e-f9d2-e063-6394a90adb182025-02-16WarningsExact identifier
application number: M005
UKOVA FOOT ODOR PROBIOTICTOLNAFTATE 1% FUNGI NAILJiashen International Trade Limited2de0225d-dd85-e2da-e063-6294a90a050b2025-02-11WarningsExact 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