FDA.reportPublic FDA data

Clotrimazole 1%

Product NDC
59779-305
11-digit product format
597790305
Labeler code
59779
Product ID
59779-305_39708e1e-2f4b-ad37-e063-6294a90afdb6
Type
HUMAN OTC DRUG
Nonproprietary name
Clotrimazole
Dosage form
CREAM
Route
TOPICAL
Labeler
CVS Pharmacy
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1993-08-31
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
Clotrimazole 1%
Brand name suffix
Athletes Foot
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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
8731f4ca-84a0-4325-895b-35bf8e2ff0e1Available 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
59779-305-01Clotrimazole 1%Athletes Foot1 in 1 CARTONCREAM16
59779-305-01Clotrimazole 1%Athletes Foot15 g in 1 TUBECREAM156
59779-305-02Clotrimazole 1%Athletes Foot28.4 g in 1 TUBECREAM28.46
59779-305-02Clotrimazole 1%Athletes Foot1 in 1 CARTONCREAM16
59779-305-03Clotrimazole 1%Athletes Foot1 in 1 CARTONCREAM16
59779-305-03Clotrimazole 1%Athletes Foot28.4 g in 1 TUBECREAM28.46

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59779-305-01GM - Gram59779-3056035961a-3b00-4c2f-87f5-cdef9b2ecc2812018-06-11
59779-305-02GM - Gram59779-3052b2af188-c2a6-4e48-beaf-da03b926fd9d12018-06-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ClotrimazoleACTIVE INGREDIENTG07GZ97H65CLOTRIMAZOLE 1% ATHLETES FOOT (CLOTRIMAZOLE) CREAM [CVS PHARMACY]2
ClotrimazoleACTIVE MOIETYG07GZ97H65CLOTRIMAZOLE 1% ATHLETES FOOT (CLOTRIMAZOLE) CREAM [CVS PHARMACY]2
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHCLOTRIMAZOLE 1% ATHLETES FOOT (CLOTRIMAZOLE) CREAM [CVS PHARMACY]2
cetostearyl alcoholINACTIVE INGREDIENT2DMT128M1SCLOTRIMAZOLE 1% ATHLETES FOOT (CLOTRIMAZOLE) CREAM [CVS PHARMACY]2
cetyl esters waxINACTIVE INGREDIENTD072FFP9GUCLOTRIMAZOLE 1% ATHLETES FOOT (CLOTRIMAZOLE) CREAM [CVS PHARMACY]2
octyldodecanolINACTIVE INGREDIENT461N1O614YCLOTRIMAZOLE 1% ATHLETES FOOT (CLOTRIMAZOLE) CREAM [CVS PHARMACY]2
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MCLOTRIMAZOLE 1% ATHLETES FOOT (CLOTRIMAZOLE) CREAM [CVS PHARMACY]2
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XCLOTRIMAZOLE 1% ATHLETES FOOT (CLOTRIMAZOLE) CREAM [CVS PHARMACY]2
waterINACTIVE INGREDIENT059QF0KO0RCLOTRIMAZOLE 1% ATHLETES FOOT (CLOTRIMAZOLE) CREAM [CVS PHARMACY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-305CLOTRIMAZOLE 1% ATHLETES FOOT (CLOTRIMAZOLE) CREAM [CVS PHARMACY]5Current NDC, Legacy NDC, 6 package rows20241105_8731f4ca-84a0-4325-895b-35bf8e2ff0e1.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 35 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ONIADBA Fungal Nail Treatment SwabsTOLNAFTATE,UNDECYLENIC ACIDShenzhen Boyimei Technology Co., Ltd.3baa99ab-6d22-8d7d-e063-6294a90af3e82025-08-05WarningsExact identifier
application number: M005
MICONAZOLE Nitrate 2% Cream ANTIFUNGALMICONAZOLE NITRATEPreferred Pharmaceuticals Inc.cca84334-2e2d-4991-9d1e-d5b7c9ffd3922025-08-01WarningsExact identifier
application number: M005
RoyceDerm CoolDefense Refreshing Shower GelTOLNAFTATE 1.0%RoyceDerm LLC3b3216d6-8cc8-ea89-e063-6294a90ab6912025-07-31WarningsExact identifier
application number: M005
SUNMARK MICONAZOLE NITRATE antifungalMICONAZOLE NITRATEStrategic Sourcing Services LLC7c15d95a-5b89-4789-8c91-3f61d7ec77072025-07-30WarningsExact identifier
application number: M005
AntifungalMICONAZOLE NITRATEAdvanced Rx LLCe13eb653-3916-444a-ae86-1738c0308b792025-07-28WarningsExact identifier
application number: M005
Meridian Unwrapped Antibacterial DeodorantBENZETHONIUM CHLORIDEYangzhou Hongshengding Chemical Co.,Ltd.a2b9570f-312c-4f46-994d-efe057b247aa2025-07-28WarningsExact identifier
application number: M005
Meridian Antibacterial DeodorantBENZETHONIUM CHLORIDEYangzhou Hongshengding Chemical Co.,Ltd.b41b130f-48fd-47d4-a94e-74433ae44de22025-07-28WarningsExact identifier
application number: M005
Rugby Clotrimazole Antifungal CreamCLOTRIMAZOLEPreferred Pharmaceuticals Inc.bd567e91-7152-4612-83e0-8e8a00c2d2c52025-07-25WarningsExact identifier
application number: M005
HongocuraUNDECYLENIC ACID, ZINC UNDECYLENATEMENPER DISTRIBUTORS, INC.c69b735e-0ffe-4328-bd9f-3c1ac6798c082025-07-22WarningsExact identifier
application number: M005
Hongocura PinceladasUNDECYLENIC ACIDMenper Distributors, Inc.4b9a3a70-d646-47c6-b969-5c4d759d23a42025-07-22WarningsExact identifier
application number: M005
Hongocura MUNDECYLENIC ACIDMENPER DISTRIBUTORS, INC.b4adb7b0-59b4-4b3c-9b0e-1869bb5431742025-07-22WarningsExact identifier
application number: M005
Hongocura SUNDECYLENIC ACIDMENPER DISTRIBUTORS, INC.4a21f371-bfc1-4e66-af16-55b3283872b72025-07-22WarningsExact identifier
application number: M005
FifthPulse Miconazole Nitrate Cream 1ozMICONAZOLE NITRATEFront Pharmaceutical PLC3a37a3a8-9d05-926c-e063-6294a90a9ed82025-07-18WarningsExact identifier
application number: M005
FifthPulse Miconazole Nitrate Cream 4ozMICONAZOLE NITRATEFront Pharmaceutical PLC3a382b79-dde9-dde0-e063-6294a90a53bb2025-07-18WarningsExact identifier
application number: M005
FifthPulse clotrimazole cream 4ozCLOTRIMAZOLE 1%Front Pharmaceutical PLC3a389093-48f2-29cb-e063-6294a90ada372025-07-18WarningsExact identifier
application number: M005
PHARMBANNER Tea Tree Oil Antifungal Soap.TEA TREE OIL ANTIFUNGAL SOAP.Shenzhen Xinxin Yunhai Technology Co., Ltd.3a0860b0-346e-7024-e063-6394a90ace812025-07-16WarningsExact identifier
application number: M005
TopCare AntifungalCLOTRIMAZOLETopco Associates LLC6757eb2a-73e0-4bd0-a332-5713fdf3445d2025-07-16WarningsExact identifier
application number: M005
UpandUp ClotrimazoleCLOTRIMAZOLETarget Corporationcb2b7d38-9988-493b-9843-56c2f59eed2f2025-07-16WarningsExact identifier
application number: M005
Jock ItchCLOTRIMAZOLETARGET Corporation1ae551e7-69de-4eef-b4f7-5e1a880e631d2025-07-16WarningsExact identifier
application number: M005
Athletes FootCLOTRIMAZOLEFRED'S, INC.d2d8f44e-2dfa-446b-855e-86e0d6d2d0df2025-07-15WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309367clotrimazole 1 % Topical CreamPSN8731f4ca-84a0-4325-895b-35bf8e2ff0e16
309367clotrimazole 10 MG/ML Topical CreamSCD8731f4ca-84a0-4325-895b-35bf8e2ff0e16
309367clotrimazole 1 % Topical CreamSY8731f4ca-84a0-4325-895b-35bf8e2ff0e16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-305-01597790305011 TUBE in 1 CARTON (59779-305-01) / 15 g in 1 TUBE1 tube1993-08-310000-00-00NoNoCurrent
59779-305-02597790305021 TUBE in 1 CARTON (59779-305-02) / 28.4 g in 1 TUBE1 tube1993-08-310000-00-00NoNoCurrent
59779-305-03597790305031 TUBE in 1 CARTON (59779-305-03) / 28.4 g in 1 TUBE1 tube2019-02-260000-00-00NoNoCurrent