FDA.reportPublic FDA data

Publix

Product NDC
41415-056
11-digit product format
414150056
Labeler code
41415
Product ID
41415-056_39adfe99-7e92-eaa4-e063-6394a90a9f59
Type
HUMAN OTC DRUG
Nonproprietary name
Clotrimazole
Dosage form
CREAM
Route
TOPICAL
Labeler
Publix Super Markets Inc
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

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage41415-056-75e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage41415-056-759bebd1f3094a…5416666fcb17…

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
Publix
Brand name suffix
athletic 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
a51679aa-5dd4-404a-98cf-cc620e233cb8Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
41415-056-752021-10-26C16284748780-19d75b9d0-2f26-f424-e053-dadaa90a57cePublix athletic foot cream
41415-056-752020-01-31C16284748780-19d75b9d0-2f26-f424-e053-dadaa90a57cePublix athletic foot cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41415-056-75Publixathletic foot30 g in 1 TUBECREAM304
41415-056-75Publixathletic foot1 in 1 CARTONCREAM14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ClotrimazoleACTIVE INGREDIENTG07GZ97H65PUBLIX ATHLETIC FOOT (CLOTRIMAZOLE) CREAM [PUBLIX SUPER MARKETS INC]1
ClotrimazoleACTIVE MOIETYG07GZ97H65PUBLIX ATHLETIC FOOT (CLOTRIMAZOLE) CREAM [PUBLIX SUPER MARKETS INC]1
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHPUBLIX ATHLETIC FOOT (CLOTRIMAZOLE) CREAM [PUBLIX SUPER MARKETS INC]1
cetostearyl alcoholINACTIVE INGREDIENT2DMT128M1SPUBLIX ATHLETIC FOOT (CLOTRIMAZOLE) CREAM [PUBLIX SUPER MARKETS INC]1
cetyl esters waxINACTIVE INGREDIENTD072FFP9GUPUBLIX ATHLETIC FOOT (CLOTRIMAZOLE) CREAM [PUBLIX SUPER MARKETS INC]1
octyldodecanolINACTIVE INGREDIENT461N1O614YPUBLIX ATHLETIC FOOT (CLOTRIMAZOLE) CREAM [PUBLIX SUPER MARKETS INC]1
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MPUBLIX ATHLETIC FOOT (CLOTRIMAZOLE) CREAM [PUBLIX SUPER MARKETS INC]1
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XPUBLIX ATHLETIC FOOT (CLOTRIMAZOLE) CREAM [PUBLIX SUPER MARKETS INC]1
waterINACTIVE INGREDIENT059QF0KO0RPUBLIX ATHLETIC FOOT (CLOTRIMAZOLE) CREAM [PUBLIX SUPER MARKETS INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41415-056PUBLIX ATHLETIC FOOT (CLOTRIMAZOLE) CREAM [PUBLIX SUPER MARKETS INC]3Current NDC, Legacy NDC, 2 package rows20241105_a51679aa-5dd4-404a-98cf-cc620e233cb8.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 37 of 49 · 969 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clotrimazole 1% Athletes FootCLOTRIMAZOLESTRATEGIC SOURCING SERVICES LLC9aba1345-ef47-4951-8448-a43d6696b6162025-07-07WarningsExact identifier
application number: M005
sunmark antifungalTOLNAFTATEStrategic Sourcing Services LLCd0c30c74-9472-4978-9623-8c7dbeb994112025-07-07WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLESun Pharmaceutical Industries, Inc.a3a5cbf5-cabb-48d8-8877-74a97f7c0f572025-07-03WarningsExact identifier
application number: M005
OMZOK ANTIFUNGAL PENUNDECYLENIC ACID 25%Shenzhen Shandian Jingling Technology Co., Ltd.38edf699-93af-e550-e063-6294a90a368c2025-07-02WarningsExact identifier
application number: M005
meijer Athletes FootCLOTRIMAZOLEMeijer Distribution Incfdb15cd8-6726-4150-9b9d-6ef3ee01a5d22025-07-02WarningsExact identifier
application number: M005
meijer antifungalTOLNAFTATEMeijer Distribution Inc374af35a-b8bb-4784-bfc8-c3342de875ca2025-07-02WarningsExact identifier
application number: M005
Rexall Jock ItchCLOTRIMAZOLEDollar General11427a79-f262-4702-9b2e-ec1955a9b2da2025-07-02WarningsExact identifier
application number: M005
Rexall Athletes FootCLOTRIMAZOLEDollar General664579a1-a5b0-4a4c-bff6-4347f3e1d3bb2025-07-02WarningsExact identifier
application number: M005
Athletes Foot AntifungalTOLNAFTATEDollar General43fc473e-c1fd-4245-af38-2e9de5ad91dc2025-07-02WarningsExact identifier
application number: M005
SEFUDUN FUNGAL NAIL PATCHESGLYCERINShenzhen Shandian Jingling Technology Co., Ltd.38db97d6-27c8-da99-e063-6294a90aac662025-07-01WarningsExact identifier
application number: M005
Tolnaftate AntifungalTOLNAFTATESun Pharmaceutical Industries, Inc.fa16fa08-fbbd-4f45-b64a-9bffe78e88612025-07-01WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEGranules Pharmaceuticals Inc.1280353c-9f96-557e-e063-6294a90a10f92025-06-30WarningsExact identifier
application number: M005
MiconazoleMICONAZOLE NITRATEChain Drug Consortium, LLC246be926-79ea-4e0c-a3ef-2aa7fc3a52bf2025-06-30WarningsExact identifier
application number: M005
Miconazole NitrateANTIFUNGAL LIQUID CONTINUOUS SPRAYChain Drug Consortium, LLC7f6912a6-a576-4138-bd78-a075a7d240362025-06-27WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL LIQUID SPRAYRite Aid Corporationaee58c44-5dba-8acb-e053-2a95a90a23af2025-06-21WarningsExact identifier
application number: M005
Miconazole NitrateATHLETES FOOT POWDER SPRAY TALC FREERite Aid Corporation5e2f2372-4b79-4b6a-bdea-74289b1e20532025-06-21WarningsExact identifier
application number: M005
TolnaftateJOCK ITCH POWDERRite Aid Corporationb6968587-45c2-d2f8-e053-2a95a90a84012025-06-21WarningsExact identifier
application number: M005
Meridian Unwrapped Antibacterial DeodorantBENZETHONIUM CHLORIDELiufangjing Biotechnology (Yangzhou) Co., Ltd67d1d65a-71d4-41fc-a71c-85a28ce6de0c2025-06-18WarningsExact identifier
application number: M005
Meridian Antibacterial DeodorantBENZETHONIUM CHLORIDELiufangjing Biotechnology (Yangzhou) Co., Ltd640df217-6982-441e-835a-dbe2031e732b2025-06-18WarningsExact identifier
application number: M005
EYELID WIPESEYELID WIPESShenzhen Shierjie Biological Engineering Co., LTD377fb842-aa78-ab2a-e063-6394a90a69f92025-06-13WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309367clotrimazole 1 % Topical CreamPSNa51679aa-5dd4-404a-98cf-cc620e233cb84
309367clotrimazole 10 MG/ML Topical CreamSCDa51679aa-5dd4-404a-98cf-cc620e233cb84
309367clotrimazole 1 % Topical CreamSYa51679aa-5dd4-404a-98cf-cc620e233cb84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41415-056-75414150056751 TUBE in 1 CARTON (41415-056-75) / 30 g in 1 TUBE1 tube2010-03-080000-00-00NoNoCurrent