Antifungal 1% Clotrimazole Cream

Product NDC
70856-3585
11-digit product format
708563585
Labeler code
70856
Product ID
70856-3585_53d444d7-86f1-6182-e063-6294a90aa85c
Type
HUMAN OTC DRUG
Nonproprietary name
Antifungal 1% Clotrimazole Cream
Dosage form
CREAM
Route
TOPICAL
Labeler
Defense Soap LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-10-01
Substance
CLOTRIMAZOLE
Active strength
1 g/100mL
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70856-358570856-3585-1DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…

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
Antifungal 1% Clotrimazole Cream
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOTRIMAZOLE1 g/100mL

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
040264b2-8f2f-f059-e063-6294a90ad720Available 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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70856-3585-1Antifungal 1% Clotrimazole Cream29.5 mL in 1 TUBECREAM29.57
70856-3585-1Antifungal 1% Clotrimazole Cream1 in 1 CARTONCREAM17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70856-3585ANTIFUNGAL 1% CLOTRIMAZOLE CREAM CREAM [DEFENSE SOAP LLC]5Current NDC, 2 package rows20241218_040264b2-8f2f-f059-e063-6294a90ad720.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 36 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tolnaftate AntifungalTOLNAFTATESTRATEGIC SOURCING SERVICES LLC97ffb6fd-5670-4783-b805-88fe9e43ca962025-07-15WarningsExact identifier
application number: M005
Miconazole NitrateMICONAZOLE NITRATESTRATEGIC SOURCING SERVICES LLC966a1000-3b08-4f2c-a9f8-568f2524b7172025-07-15WarningsExact identifier
application number: M005
Tolnaftate AntifungalTOLNAFTATEAmerisource Bergena3c9b783-4a36-46b3-a0dc-0696907eaebb2025-07-15WarningsExact identifier
application number: M005
Clotrimazole Jock ItchCLOTRIMAZOLERite Aid Corporationc2875c05-eedd-4546-89dd-ed88b3f28abd2025-07-14WarningsExact identifier
application number: M005
Signature Care Jock ItchCLOTRIMAZOLESafeway Inc.9ec8b527-0f03-4433-8d33-635e746fdf792025-07-14WarningsExact identifier
application number: M005
RingwormCLOTRIMAZOLEWalgreen Company42ee3ebc-4d8f-4ece-950d-5636699a2b2e2025-07-11WarningsExact identifier
application number: M005
Walgreens Jock ItchCLOTRIMAZOLEWalgreen Company2d6d7ac8-9f62-4670-9aa2-e73c29034de92025-07-11WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEWalgreen Company5cc1c525-8ff2-429b-97ec-129e0100db472025-07-11WarningsExact identifier
application number: M005
Live Better AntifungalCLOTRIMAZOLEThe Great Atlantic & Pacific Tea Company7b2e44b9-b1ac-48c8-994d-4e9682ec8bad2025-07-11WarningsExact identifier
application number: M005
CVS Antifungal RingwormCLOTRIMAZOLECVS Pharmacy638c7fd6-cec4-4c14-9f49-de56587211992025-07-11WarningsExact identifier
application number: M005
CVS Pharmacy ITCH RELIEF ANTIFUNGALCLOTRIMAZOLECVS Pharmacy68163ef4-d23d-43ac-bb52-9b4ba3cba2d02025-07-11WarningsExact identifier
application number: M005
HEB AntifungalCLOTRIMAZOLEH E B8f07dc5a-cfa8-4a57-ac90-552a7c947cc52025-07-11WarningsExact identifier
application number: M005
Publix athletic footCLOTRIMAZOLEPublix Super Markets Inca51679aa-5dd4-404a-98cf-cc620e233cb82025-07-11WarningsExact identifier
application number: M005
Terrasil Athletes Foot AntiFungal Treatment MaxCLOTRIMAZOLEAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutionsfce478a0-05f5-4606-82ce-c8dd095df2112025-07-11WarningsExact identifier
application number: M005
Terrasil Tinea Treatment MAXCLOTRIMAZOLEAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutionsd0b14dcb-89a7-42f6-b6ae-8f19c4e6aaaa2025-07-11WarningsExact identifier
application number: M005
Clotrimazole 1% Athletes FootCLOTRIMAZOLECVS Pharmacy8731f4ca-84a0-4325-895b-35bf8e2ff0e12025-07-08WarningsExact identifier
application number: M005
CAREONE ClotrimazoleCLOTRIMAZOLEAmerican Sales Company68915156-8927-4ace-9497-5e510d1edcca2025-07-08WarningsExact identifier
application number: M005
Clotrimazole Athletes FootCLOTRIMAZOLEWal-Mart Stores, Inc.1440cf4d-e075-4137-a8ee-f41bd449c9982025-07-08WarningsExact identifier
application number: M005
Good Neighbor Pharmacy ClotrimazoleCLOTRIMAZOLEAmerisourceBergenadf75d72-26a7-4f4e-bba5-34a6fbe2a4cc2025-07-08WarningsExact identifier
application number: M005
Kroger ATHLETES FOOTCLOTRIMAZOLEKroger Company9e623f18-3e00-4952-b347-337d83fe3acb2025-07-08WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309367clotrimazole 1 % Topical CreamPSN040264b2-8f2f-f059-e063-6294a90ad7207
309367clotrimazole 10 MG/ML Topical CreamSCD040264b2-8f2f-f059-e063-6294a90ad7207
309367clotrimazole 1 % Topical CreamSY040264b2-8f2f-f059-e063-6294a90ad7207

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70856-3585-1708563585011 TUBE in 1 CARTON (70856-3585-1) / 29.5 mL in 1 TUBE1 tube2024-10-01NoNoCurrent