FDA.reportPublic FDA data

Clotrimazole

Product NDC
63187-501
11-digit product format
631870501
Labeler code
63187
Product ID
63187-501_b07d0172-22a5-4baf-a501-8c7c18b77ecb
Type
HUMAN OTC DRUG
Nonproprietary name
Clotrimazole
Dosage form
CREAM
Route
TOPICAL
Labeler
Proficient Rx LP
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1995-06-01
Substance
CLOTRIMAZOLE
Active strength
1 g/100g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOTRIMAZOLE1 g/100g

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
ba1dc4a4-073f-4f30-bb9c-9ed043700431Available 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
63187-501-15Clotrimazole15 g in 1 TUBECREAM156
63187-501-15Clotrimazole1 in 1 CARTONCREAM16
63187-501-30Clotrimazole1 in 1 CARTONCREAM16
63187-501-30Clotrimazole30 g in 1 TUBECREAM306

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ClotrimazoleACTIVE INGREDIENTG07GZ97H65CLOTRIMAZOLE CREAM [PROFICIENT RX LP]1
ClotrimazoleACTIVE MOIETYG07GZ97H65CLOTRIMAZOLE CREAM [PROFICIENT RX LP]1
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHCLOTRIMAZOLE CREAM [PROFICIENT RX LP]1
cetostearyl alcoholINACTIVE INGREDIENT2DMT128M1SCLOTRIMAZOLE CREAM [PROFICIENT RX LP]1
cetyl esters waxINACTIVE INGREDIENTD072FFP9GUCLOTRIMAZOLE CREAM [PROFICIENT RX LP]1
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MCLOTRIMAZOLE CREAM [PROFICIENT RX LP]1
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XCLOTRIMAZOLE CREAM [PROFICIENT RX LP]1
waterINACTIVE INGREDIENT059QF0KO0RCLOTRIMAZOLE CREAM [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-501CLOTRIMAZOLE CREAM [PROFICIENT RX LP]6Current NDC, Legacy NDC, 4 package rows20240123_ba1dc4a4-073f-4f30-bb9c-9ed043700431.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 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kroger Jock ItchCLOTRIMAZOLEKroger Companycc536b67-8b0b-4939-b0fb-9a9e4188c4e52025-07-08WarningsExact identifier
application number: M005
Rite Aid antifungal ringwormCLOTRIMAZOLERite Aid Corporation1ad7cd82-d01b-403e-a2c1-2302db2a78df2025-07-08WarningsExact identifier
application number: M005
ConazolMICONAZOLE NITRATELaboratorios Liomont, S.A. de C.V.84780538-8618-5750-e053-2a91aa0a60542025-07-07WarningsExact identifier
application number: M005
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309367clotrimazole 1 % Topical CreamPSNba1dc4a4-073f-4f30-bb9c-9ed0437004316
309367clotrimazole 10 MG/ML Topical CreamSCDba1dc4a4-073f-4f30-bb9c-9ed0437004316
309367clotrimazole 1 % Topical CreamSYba1dc4a4-073f-4f30-bb9c-9ed0437004316

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-501-15631870501151 TUBE in 1 CARTON (63187-501-15) / 15 g in 1 TUBE1 tube2015-02-020000-00-00NoNoCurrent
63187-501-30631870501301 TUBE in 1 CARTON (63187-501-30) / 30 g in 1 TUBE1 tube2015-02-020000-00-00NoNoCurrent