FDA.reportPublic FDA data

LEADER ATHLETES FOOT CLOTRIMAZOLE

Product NDC
70000-0542
11-digit product format
700000542
Labeler code
70000
Product ID
70000-0542_df312adc-dfcb-4692-aec9-cdcfe3ac46c0
Type
HUMAN OTC DRUG
Nonproprietary name
CLOTRIMAZOLE
Dosage form
CREAM
Route
TOPICAL
Labeler
LEADER
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-01-17
Substance
CLOTRIMAZOLE
Active strength
.01 g/g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70000-054270000-0542-1DDiscontinued by firm2026-10-16

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 NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70000-0542-1DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70000-0542-2UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70000-0542-1UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
LEADER ATHLETES FOOT CLOTRIMAZOLE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOTRIMAZOLE.01 g/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
dcea717b-b097-4a40-8e38-05212731a7efAvailable 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
70000-0542-1LEADER ATHLETES FOOT CLOTRIMAZOLE14 g in 1 TUBECREAM145
70000-0542-1LEADER ATHLETES FOOT CLOTRIMAZOLE1 in 1 CARTONCREAM15
70000-0542-2LEADER ATHLETES FOOT CLOTRIMAZOLE28 g in 1 TUBECREAM285
70000-0542-2LEADER ATHLETES FOOT CLOTRIMAZOLE1 in 1 CARTONCREAM15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0542-1GM - Gram70000-0542d6ae9d11-691d-49f5-950d-4d157044cbfc12023-07-06
70000-0542-2GM - Gram70000-0542e04a50d2-c31d-46b1-b79d-f95392048ca712021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0542LEADER ATHLETES FOOT CLOTRIMAZOLE (CLOTRIMAZOLE) CREAM [LEADER]3Current NDC, Legacy NDC, 4 package rows20250117_dcea717b-b097-4a40-8e38-05212731a7ef.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 4 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Maximum Strength Antifungal LiquidTOLNAFTATEMeijer Distribution Inc0b3eb169-b309-8c1a-e063-6294a90a726e2026-08-03WarningsExact identifier
application number: M005
ProCure Antifungal CreamMICONAZOLE NITRATE 2%Twin Med LLC39d55df5-8a8e-3a9b-e063-6294a90af20b2026-08-03WarningsExact identifier
application number: M005
MiratiFul Nail Fungus TreatmentTOLNAFTATETexas MiratiFul Enterprises Inc.35eb20e3-86d4-4bec-b572-3d5fe86ac74d2026-08-03WarningsExact identifier
application number: M005
LUCKSKY Fungal Nail RenewalUNDECYLENIC ACID 25% TOLNAFTATE1% FUNGAL NAIL RENEWALWenzhou Yuyuan Pharmaceutical Co., Ltd.57a73b60-bbac-97e6-e063-6294a90ab9a92026-07-28WarningsExact identifier
application number: M005
Ponamfo ANTIFUNGAL TREATMENT PENUNDECYLENICGuangzhou Bixiaoyu Trading Co., Ltd.57a9ccff-270b-9769-e063-6394a90a5e0c2026-07-28WarningsExact identifier
application number: M005
FUNGAL NAIL PATCHESUNDECYLENIC ACIDGuangzhou Hechuang Commercial Service Co.,Ltd.5240412c-4257-8e9d-e063-6394a90a0a122026-07-28WarningsExact identifier
application number: M005
FFPMAM Antifungal CreamFFPMAM ANTIFUNGAL CREAMGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd57b7cf61-d4cd-53f7-e063-6394a90afc542026-07-28WarningsExact identifier
application number: M005
Natural Vine Fungal Nail patchesTOLNAFTATE 1%GETHSEMANE BRANCH CORPORATION57905962-0745-ceee-e063-6294a90a88dd2026-07-26WarningsExact identifier
application number: M005
antifungal penANTIFUNGAL PENGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd5756256e-ed2b-4e13-e063-6294a90a1e0f2026-07-24WarningsExact identifier
application number: M005
SERYNTH ANTIFUNGAL NAIL TREATMENT PENUNDECYLENIC ACID 25% ANTIFUNGAL NAIL TREATMENT PENJiangxi Yudexi Pharmaceutical Co., LTD4d59116a-bcd0-9ed4-e063-6394a90a6dbd2026-07-24WarningsExact identifier
application number: M005
SERYNTH MULTI-PURPOSE FUNCUSTOLNAFTATE 1% MULTI-PURPOSE FUNCUSJiangxi Yudexi Pharmaceutical Co., LTD4a6ea0c9-1495-8ede-e063-6294a90ad0932026-07-23WarningsExact identifier
application number: M005
HELPS WITH NAGELPILZTOLNAFTATE 1% HELPS WITH NAGELPILZ LIQUIDShanghai Honghui Chuang Intelligent Technology Co., Ltd55753a4a-a4d0-a183-e063-6394a90acf112026-07-22WarningsExact identifier
application number: M005
FUNGAL NAIL TREATMENT kit .liquid.PSEUDOLARIX AMABILIS BARK 1%GETHSEMANE BRANCH CORPORATION5719942d-6b10-612e-e063-6294a90a4fe92026-07-21WarningsExact identifier
application number: M005
BeamBalm ANTIFUNGAL CARE ESSENTIAL OilUNDECYLENIC ACID 10% ANTIFUNGAL CARE ESSENTIAL OILJiangxi Yudexi Pharmaceutical Co., LTD4ff57d2d-5e74-a995-e063-6394a90a3f9a2026-07-21WarningsExact identifier
application number: M005
WERPEKA FUNGAL NAIL RENEWALUNDECYLENIC ACID 25% FUNGAL NAIL RENEWALJiangxi Yudexi Pharmaceutical Co., LTD4f7a8273-b7af-d532-e063-6394a90aa63a2026-07-21WarningsExact identifier
application number: M005
HTRCSW FUNGAL NAIL RENEWALUNDECYLENIC ACID 25% TOENAIL FUNGUS PENJiangxi Yudexi Pharmaceutical Co., LTD523bc484-511c-b603-e063-6394a90a55ae2026-07-21WarningsExact identifier
application number: M005
DERMFREE ClotrimazoleCLOTRIMAZOLE1% CLOTRIMAZOLEJiangxi Yudexi Pharmaceutical Co., LTD49ab5abb-d311-505d-e063-6294a90a56162026-07-21WarningsExact identifier
application number: M005
DERMFREE FUNGI NAILTOLNAFTATE 1% FUNGI NAILJiangxi Yudexi Pharmaceutical Co., LTD49aba00d-9249-b403-e063-6394a90a787d2026-07-21WarningsExact identifier
application number: M005
SKAPEMED SKIN REPAIRTOLNAFTATE 1% SKIN REPAIRJiangxi Yudexi Pharmaceutical Co., LTD4a20c32e-0551-aead-e063-6394a90a2aa72026-07-21WarningsExact identifier
application number: M005
REINREUDE MULTI-PURPOSE TREATMENTTOLNAFTATE 1% MULTI-PURPOSE TREATMENTJiangxi Yudexi Pharmaceutical Co., LTD4a380945-9235-783a-e063-6294a90a094d2026-07-21WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309367clotrimazole 1 % Topical CreamPSNdcea717b-b097-4a40-8e38-05212731a7ef5
309367clotrimazole 10 MG/ML Topical CreamSCDdcea717b-b097-4a40-8e38-05212731a7ef5
309367clotrimazole 1 % Topical CreamSYdcea717b-b097-4a40-8e38-05212731a7ef5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0542-1700000542011 TUBE in 1 CARTON (70000-0542-1) > 14 g in 1 TUBE1 tube2020-01-220000-00-00NoNoCurrent
70000-0542-2700000542021 TUBE in 1 CARTON (70000-0542-2) / 28 g in 1 TUBE1 tube2020-01-172027-01-31NoNoCurrent