FDA.reportPublic FDA data

Clotrimazole

Product NDC
49035-812
11-digit product format
490350812
Labeler code
49035
Product ID
49035-812_3970f9b7-3626-fd44-e063-6394a90aa09f
Type
HUMAN OTC DRUG
Nonproprietary name
Clotrimazole
Dosage form
CREAM
Route
TOPICAL
Labeler
Wal-Mart Stores, 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

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
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
1440cf4d-e075-4137-a8ee-f41bd449c998Available 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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-812-01ClotrimazoleAthletes Foot15 g in 1 TUBECREAM155
49035-812-01ClotrimazoleAthletes Foot1 in 1 CARTONCREAM15
49035-812-27ClotrimazoleAthletes Foot60 g in 1 TUBECREAM605
49035-812-27ClotrimazoleAthletes Foot1 in 1 CARTONCREAM15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-812-27GM - Gram49035-812b3bbda9c-5749-49cd-a09c-aace6be6431012015-02-02

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-812CLOTRIMAZOLE ATHLETES FOOT (CLOTRIMAZOLE) CREAM [WAL-MART STORES, INC.]4Current NDC, Legacy NDC, 4 package rows20241115_1440cf4d-e075-4137-a8ee-f41bd449c998.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 17 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Velloryn ANTIFUNGAL CreamZINC UNDECYLENATE, UNDECYLENIC ACIDGuangdong Quadrant Ecological Technology Co., Ltd.4e38e1f1-0466-5b91-e063-6294a90a66c42026-03-30WarningsExact identifier
application number: M005
APUREE Nailtific Extra-Max Strength Daytime AntigungalAPUREE NAILTIFIC EXTRA-MAX STRENGTH DAYTIME ANTIGUNGALGuangzhou Meixi Biotechnology Co., Ltd.4e3d226b-57f1-75a6-e063-6394a90a96cd2026-03-30WarningsExact identifier
application number: M005
APUREE Nailtific Extra-Max Strength Nighttime AntifungalAPUREE NAILTIFIC EXTRA-MAX STRENGTH NIGHTTIME ANTIFUNGALGuangzhou Meixi Biotechnology Co., Ltd.4e3e8895-34b4-de69-e063-6294a90a55322026-03-30Exact identifier
application number: M005
Miconazole NitrateATHLETES FOOT POWDER SPRAY TALC FREECVS Pharmacy3380263d-ee7b-4946-a467-35a24789a9012026-03-27WarningsExact identifier
application number: M005
Micro-Guard (AF)MICONAZOLE NITRATEColoplast Corpa43a94d0-fec0-470f-bdb4-535dcce6d1e02026-03-27WarningsExact identifier
application number: M005
Suave Antibacterial Hand Wash Fresh CitrusLIQUID HAND WASH ANTIBACTERIALSuave Brands Co, LLC41d77ec6-a1d1-13dc-e063-6394a90a95f42026-03-26WarningsExact identifier
application number: M005
Suave Antibacterial Hand Wash Deeply CleanLIQUID HAND WASH ANTIBACTERIALSuave Brands Co, LLC41d83736-66da-abb9-e063-6294a90a3d672026-03-26WarningsExact identifier
application number: M005
Suave Antibacterial Hand Wash Sea Minerals and Aloe VeraLIQUID HAND WASH ANTIBACTERIALSuave Brands Co, LLC41d8848c-d157-6e2c-e063-6294a90aa2592026-03-26WarningsExact identifier
application number: M005
Hermon Jock Itch Antifungal Treatment Kit Antifungal Cream and .Soap. for Jock ItchANTIFUNGAL TREATMENT KITBeautivity LLC4800a93b-7042-827b-e063-6294a90acd952026-03-25WarningsExact identifier
application number: M005
Toenail Fungus TreatmentTERBINAFINEShenzhen Wankelai E-commerce Co., Ltd.4dc1d7f7-e4ae-c54b-e063-6394a90aa4202026-03-24WarningsExact identifier
application number: M005
Lasolex Liquid SolutionCLOTRIMAZOLE 1%PureTek Corporation4dc9e64d-8235-b218-e063-6394a90a01572026-03-24WarningsExact identifier
application number: M005
Hermon Jock Itch Antifungal Treatment .Soap. BarTOLNAFTATE 1%Beautivity LLC4dbbf09b-5bc1-501b-e063-6394a90a2a9d2026-03-23WarningsExact identifier
application number: M005
Hermon Jock Itch Antifungal Treatment CreamMICONAZOLE NITRATE 2%Beautivity LLC4dbc521c-2f5f-9736-e063-6294a90ad85d2026-03-23WarningsExact identifier
application number: M005
seebeellar clotrimazole 1% antifungal creamSEEBEELLAR CLOTRIMAZOLE 1% ANTIFUNGAL CREAMGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd4d80e551-76c2-150a-e063-6394a90a79962026-03-20WarningsExact identifier
application number: M005
Nail Fungal PenUNDECYLENIC ACIDGuangzhou Hechuang Commercial Service Co.,Ltd.4d5b5c22-4781-6391-e063-6294a90a70102026-03-19WarningsExact identifier
application number: M005
HAND SANITIZER MADRID MUSEALCOHOL HAND SANITIZERCROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.4d5cecf6-c232-6cd9-e063-6394a90a03e92026-03-19WarningsExact identifier
application number: M005
HAND SANITIZER VALENCIA VIBESALCOHOL HAND SANITIZERCROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.4d5de4d6-4c58-f393-e063-6294a90a323a2026-03-19WarningsExact identifier
application number: M005
Toenail Fungus PenUNDECYLENIC ACIDGuangzhou Hechuang Commercial Service Co.,Ltd.4d5e256f-7fd5-f903-e063-6394a90a11602026-03-19WarningsExact identifier
application number: M005
HAND SANITIZER MALLORCA BREEZEALCOHOL HAND SANITIZERCROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.4d5e50de-62fd-f9e9-e063-6394a90af0bd2026-03-19WarningsExact identifier
application number: M005
HAND SANITIZER MAR BELLAALCOHOL HAND SANITIZERCROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.4d6005d9-5d4d-033e-e063-6294a90ad36f2026-03-19WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309367clotrimazole 1 % Topical CreamPSN1440cf4d-e075-4137-a8ee-f41bd449c9985
309367clotrimazole 10 MG/ML Topical CreamSCD1440cf4d-e075-4137-a8ee-f41bd449c9985
309367clotrimazole 1 % Topical CreamSY1440cf4d-e075-4137-a8ee-f41bd449c9985

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-812-01490350812011 TUBE in 1 CARTON (49035-812-01) / 15 g in 1 TUBE1 tube1993-08-310000-00-00NoNoCurrent
49035-812-27490350812271 TUBE in 1 CARTON (49035-812-27) / 60 g in 1 TUBE1 tube1993-08-310000-00-00NoNoCurrent