Clotrimazole

Product NDC
51672-2002
11-digit product format
516722002
Labeler code
51672
Product ID
51672-2002_390cee55-c38f-accf-e063-6294a90ab7f7
Type
HUMAN OTC DRUG
Nonproprietary name
Clotrimazole
Dosage form
CREAM
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
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
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
Listing expiration
2026-12-31

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
a3a5cbf5-cabb-48d8-8877-74a97f7c0f57Available 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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
51672-2002-1Clotrimazole15 g in 1 TUBECREAM154
51672-2002-1Clotrimazole1 in 1 CARTONCREAM14
51672-2002-2Clotrimazole30 g in 1 TUBECREAM304
51672-2002-2Clotrimazole1 in 1 CARTONCREAM14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-2002-1GM - Gram51672-20024c2e5eee-4d44-4728-9055-74c57d45325912012-07-24
51672-2002-2GM - Gram51672-200288f9179a-bac8-4b62-817d-35adddf30d7012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ClotrimazoleACTIVE INGREDIENTG07GZ97H65CLOTRIMAZOLE CREAM [PROFICIENT RX LP]1
ClotrimazoleACTIVE INGREDIENTG07GZ97H65CLOTRIMAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
ClotrimazoleACTIVE INGREDIENTG07GZ97H65CLOTRIMAZOLE CREAM [H.J. HARKINS COMPANY, INC.]1
ClotrimazoleACTIVE INGREDIENTG07GZ97H65CLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP]1
ClotrimazoleACTIVE MOIETYG07GZ97H65CLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP]1
ClotrimazoleACTIVE MOIETYG07GZ97H65CLOTRIMAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
ClotrimazoleACTIVE MOIETYG07GZ97H65CLOTRIMAZOLE CREAM [PROFICIENT RX LP]1
ClotrimazoleACTIVE MOIETYG07GZ97H65CLOTRIMAZOLE CREAM [H.J. HARKINS COMPANY, INC.]1
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHCLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP]1
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHCLOTRIMAZOLE CREAM [PROFICIENT RX LP]1
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHCLOTRIMAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHCLOTRIMAZOLE CREAM [H.J. HARKINS COMPANY, INC.]1
cetostearyl alcoholINACTIVE INGREDIENT2DMT128M1SCLOTRIMAZOLE CREAM [PROFICIENT RX LP]1
cetostearyl alcoholINACTIVE INGREDIENT2DMT128M1SCLOTRIMAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
cetostearyl alcoholINACTIVE INGREDIENT2DMT128M1SCLOTRIMAZOLE CREAM [H.J. HARKINS COMPANY, INC.]1
cetostearyl alcoholINACTIVE INGREDIENT2DMT128M1SCLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP]1
cetyl esters waxINACTIVE INGREDIENTD072FFP9GUCLOTRIMAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
cetyl esters waxINACTIVE INGREDIENTD072FFP9GUCLOTRIMAZOLE CREAM [PROFICIENT RX LP]1
cetyl esters waxINACTIVE INGREDIENTD072FFP9GUCLOTRIMAZOLE CREAM [H.J. HARKINS COMPANY, INC.]1
cetyl esters waxINACTIVE INGREDIENTD072FFP9GUCLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP]1
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MCLOTRIMAZOLE CREAM [PROFICIENT RX LP]1
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MCLOTRIMAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MCLOTRIMAZOLE CREAM [H.J. HARKINS COMPANY, INC.]1
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MCLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP]1
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XCLOTRIMAZOLE CREAM [PROFICIENT RX LP]1
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XCLOTRIMAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XCLOTRIMAZOLE CREAM [H.J. HARKINS COMPANY, INC.]1
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XCLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP]1
waterINACTIVE INGREDIENT059QF0KO0RCLOTRIMAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
waterINACTIVE INGREDIENT059QF0KO0RCLOTRIMAZOLE CREAM [H.J. HARKINS COMPANY, INC.]1
waterINACTIVE INGREDIENT059QF0KO0RCLOTRIMAZOLE CREAM [PROFICIENT RX LP]1
waterINACTIVE INGREDIENT059QF0KO0RCLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-2002CLOTRIMAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3Current NDC, Legacy NDC, 4 package rows20241115_a3a5cbf5-cabb-48d8-8877-74a97f7c0f57.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 7 of 51 · 1,004 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
iBeaLee Nail Repair PenIBEALEE NAIL REPAIR PENShenzhen Earth Surface Trading Co., Ltd.564dc711-7fe2-7a8d-e063-6294a90aac262026-07-10WarningsExact identifier
application number: M005
EZBIORT 1% Tolnaftate Nail Essence with BiotinTOLNAFTATEGuangzhou Borderless Technology Co., Ltd.5629df38-1079-be4f-e063-6394a90a1c6a2026-07-09WarningsExact identifier
application number: M005
ZENJBUST Undecylenic Acid 25% Antifungal PenUNDECYLENIC ACID 25% ANTIFUNGAL PENShenzhen Xituo Electronics Co., Ltd563a6704-f662-3f08-e063-6394a90a43692026-07-09WarningsExact identifier
application number: M005
Antifungal CreamANTIFUNGALPreferred Pharmaceuticals Inc.c6098653-351a-449f-9b1a-0c617074f2b92026-07-08WarningsExact identifier
application number: M005
YEARCHOICE Fungal Nail RenewalFUNGAL NAIL RENEWALGuangzhou Jingliang Cosmetics Co., Ltd.561b650d-028c-687c-e063-6394a90a166a2026-07-08WarningsExact identifier
application number: M005
CAREALL ClotrimazoleCLOTRIMAZOLENew World Imports, Inc561d3e64-ab9c-1074-e063-6394a90a12982026-07-08WarningsExact identifier
application number: M005
Beautifier Life ALCOHOL WIPESBEAUTIFIER LIFE ALCOHOL WIPESShenzhen Shierjie Biological Engineering Co., LTD323ef469-e37c-00ad-e063-6394a90ab6f72026-07-08WarningsExact identifier
application number: M005
Folliculitis Treatment CreamMICONAZOLE NITRATE 2%Guangxi Keyun E-commerce Co., Ltd.5625652a-193d-0318-e063-6294a90a56f32026-07-08WarningsExact identifier
application number: M005
Cysndra Ringworm CreamMICONAZOLE NITRATE, HYDROCORTISONEGuangzhou Xinhongda Trading Service Co., Ltd.55ed83eb-0e67-e516-e063-6394a90af4432026-07-06WarningsExact identifier
application number: M005
PureWellness FUNGAL FUSION Antifungal and Antimicrobial KitFUNGAL FUSION ANTIFUNGAL AND ANTIMICROBIAL KITPureWellness LLC25db8c55-0fa9-4795-8e05-4d3a7aaf01482026-07-06WarningsExact identifier
application number: M005
Cysndra Fungal Nail RevitalizerUNDECYLENIC ACIDGuangzhou Xinhongda Trading Service Co., Ltd.55e9f1cf-4055-6c27-e063-6394a90ac3732026-07-05WarningsExact identifier
application number: M005
FUNGAL NAIL NIGHTTIME RENEWAL PATCHESTOLNAFTATE 1%100 KARMA INC3b9ab6e0-8773-f909-e063-6394a90ac1c92026-07-03WarningsExact identifier
application number: M005
TOENAIL FUNGUS TREATMENT25% UNDECYLENIC ACID100 KARMA INC3bb000dc-5e6c-b43b-e063-6394a90a63a92026-07-03WarningsExact identifier
application number: M005
Treatonic Toenail Fungus Treatment KitTOENAIL FUNGUS TREATMENT100 KARMA INC3d4bbc65-955f-8fd8-e063-6294a90adc442026-07-03WarningsExact identifier
application number: M005
Treatonic Nailtonic Repair Pens25% UNDECYLENIC ACID100 KARMA INC4a9c32b3-e78d-3c85-e063-6394a90a7bf22026-07-03WarningsExact identifier
application number: M005
Initial Treatonic FUNGAL NAIL RENEWAL PATCHESTOLNAFTATE 1%100 KARMA INC48e377b4-abb1-34cf-e063-6294a90a2ea32026-07-03WarningsExact identifier
application number: M005
Treatonic TONENAIL FUNGUS TREATONIC kit.25% UNDECYLENIC ACID AND TOLNAFTATE 1%100 KARMA INC4c197131-9ca8-6024-e063-6294a90aa9cb2026-07-03WarningsExact identifier
application number: M005
Treatonic Antifungal Pen25% UNDECYLENIC ACID100 KARMA INC52d89172-e8a7-70c0-e063-6294a90a35632026-07-03WarningsExact identifier
application number: M005
FUNGINIX ANTI-FUNGAL TREATMENTUNDECYLENIC ACIDThe Sisquoc Healthcare Corporation92db5433-5a1b-4cb9-b8eb-217c2a807a992026-07-02WarningsExact identifier
application number: M005
Anti DandruffKETOCONAZOLEGuangzhou ChuanMa International Trading Co.,Ltd.4cfe234c-49c0-18e8-e063-6294a90a0b1d2026-07-02WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309367clotrimazole 1 % Topical CreamPSN1e7e74f6-9bca-48ab-804a-a7a81df3b6087
309367clotrimazole 1 % Topical CreamPSN9afb964c-9b88-4701-adcf-7070e25cb6c17
309367clotrimazole 10 MG/ML Topical CreamSCD1e7e74f6-9bca-48ab-804a-a7a81df3b6087
309367clotrimazole 10 MG/ML Topical CreamSCD9afb964c-9b88-4701-adcf-7070e25cb6c17
309367clotrimazole 1 % Topical CreamSY1e7e74f6-9bca-48ab-804a-a7a81df3b6087
309367clotrimazole 1 % Topical CreamSY9afb964c-9b88-4701-adcf-7070e25cb6c17
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
309367clotrimazole 1 % Topical CreamPSN70e1efac-1738-43db-b19c-bbe02810b6e75
309367clotrimazole 10 MG/ML Topical CreamSCD70e1efac-1738-43db-b19c-bbe02810b6e75
309367clotrimazole 1 % Topical CreamSY70e1efac-1738-43db-b19c-bbe02810b6e75
309367clotrimazole 1 % Topical CreamPSNa3a5cbf5-cabb-48d8-8877-74a97f7c0f574
309367clotrimazole 10 MG/ML Topical CreamSCDa3a5cbf5-cabb-48d8-8877-74a97f7c0f574
309367clotrimazole 1 % Topical CreamSYa3a5cbf5-cabb-48d8-8877-74a97f7c0f574
309367clotrimazole 1 % Topical CreamPSNb69db78b-5f10-8ca2-e053-2a95a90ac88c2
309367clotrimazole 1 % Topical CreamPSN01b1b76f-0c11-437f-82b5-931670c27a8d2
309367clotrimazole 10 MG/ML Topical CreamSCDb69db78b-5f10-8ca2-e053-2a95a90ac88c2
309367clotrimazole 10 MG/ML Topical CreamSCD01b1b76f-0c11-437f-82b5-931670c27a8d2
309367clotrimazole 1 % Topical CreamSYb69db78b-5f10-8ca2-e053-2a95a90ac88c2
309367clotrimazole 1 % Topical CreamSY01b1b76f-0c11-437f-82b5-931670c27a8d2
309367clotrimazole 1 % Topical CreamPSN8fcf70e8-70e2-4b41-99c0-a351b2c3a2a01
309367clotrimazole 1 % Topical CreamPSN8e1058cf-1bd4-4c81-81a5-3a1754caca3f1
309367clotrimazole 1 % Topical CreamPSNdeaa88bc-f7b0-16e2-e053-2995a90ac45a1
309367clotrimazole 10 MG/ML Topical CreamSCD8fcf70e8-70e2-4b41-99c0-a351b2c3a2a01
309367clotrimazole 10 MG/ML Topical CreamSCD8e1058cf-1bd4-4c81-81a5-3a1754caca3f1
309367clotrimazole 10 MG/ML Topical CreamSCDdeaa88bc-f7b0-16e2-e053-2995a90ac45a1
309367clotrimazole 1 % Topical CreamSY8fcf70e8-70e2-4b41-99c0-a351b2c3a2a01
309367clotrimazole 1 % Topical CreamSY8e1058cf-1bd4-4c81-81a5-3a1754caca3f1
309367clotrimazole 1 % Topical CreamSYdeaa88bc-f7b0-16e2-e053-2995a90ac45a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-2002-1516722002011 TUBE in 1 CARTON (51672-2002-1) / 15 g in 1 TUBE1 tube1995-06-010000-00-00NoNoCurrent
51672-2002-2516722002021 TUBE in 1 CARTON (51672-2002-2) / 30 g in 1 TUBE1 tube1995-06-010000-00-00NoNoCurrent