FDA.reportPublic FDA data

clotrimazole

Product NDC
45802-434
11-digit product format
458020434
Labeler code
45802
Product ID
45802-434_467f8f2f-09b1-4701-b796-57a10576f7ca
Type
HUMAN OTC DRUG
Nonproprietary name
Clotrimazole
Dosage form
CREAM
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-06-03
Marketing end
2027-04-30
Substance
CLOTRIMAZOLE
Active strength
1 g/100g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
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 packagepackage45802-43445802-434-01DDiscontinued by firm2026-10-12

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

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
3dcd0158-ec51-4fa7-a26a-02c2926156c0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-434-01clotrimazole15 g in 1 TUBECREAM158
45802-434-01clotrimazole1 in 1 CARTONCREAM18
45802-434-11clotrimazole1 in 1 CARTONCREAM18
45802-434-11clotrimazole28 g in 1 TUBECREAM288

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-434-01GM - Gram45802-434d14ca4ba-e10d-4e66-9753-635847aed1a612012-07-24
45802-434-11GM - Gram45802-434a0b1e4f4-5f17-41be-ab4f-f972953bca2e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLOTRIMAZOLEACTIVE INGREDIENTG07GZ97H65CLOTRIMAZOLE CREAM [PERRIGO NEW YORK INC]3
CLOTRIMAZOLEACTIVE MOIETYG07GZ97H65CLOTRIMAZOLE CREAM [PERRIGO NEW YORK INC]3
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHCLOTRIMAZOLE CREAM [PERRIGO NEW YORK INC]3
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SCLOTRIMAZOLE CREAM [PERRIGO NEW YORK INC]3
CETYL ESTERS WAXINACTIVE INGREDIENTD072FFP9GUCLOTRIMAZOLE CREAM [PERRIGO NEW YORK INC]3
OCTYLDODECANOLINACTIVE INGREDIENT461N1O614YCLOTRIMAZOLE CREAM [PERRIGO NEW YORK INC]3
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MCLOTRIMAZOLE CREAM [PERRIGO NEW YORK INC]3
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XCLOTRIMAZOLE CREAM [PERRIGO NEW YORK INC]3
WATERINACTIVE INGREDIENT059QF0KO0RCLOTRIMAZOLE CREAM [PERRIGO NEW YORK INC]3
CLOTRIMAZOLEACTIVE INGREDIENTG07GZ97H65CLOTRIMAZOLE CREAM [PROFICIENT RX LP]1
CLOTRIMAZOLEACTIVE INGREDIENTG07GZ97H65CLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP]1
CLOTRIMAZOLEACTIVE MOIETYG07GZ97H65CLOTRIMAZOLE CREAM [PROFICIENT RX LP]1
CLOTRIMAZOLEACTIVE MOIETYG07GZ97H65CLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHCLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHCLOTRIMAZOLE CREAM [PROFICIENT RX LP]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SCLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SCLOTRIMAZOLE CREAM [PROFICIENT RX LP]1
CETYL ESTERS WAXINACTIVE INGREDIENTD072FFP9GUCLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP]1
CETYL ESTERS WAXINACTIVE INGREDIENTD072FFP9GUCLOTRIMAZOLE CREAM [PROFICIENT RX LP]1
OCTYLDODECANOLINACTIVE INGREDIENT461N1O614YCLOTRIMAZOLE CREAM [PROFICIENT RX LP]1
OCTYLDODECANOLINACTIVE INGREDIENT461N1O614YCLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MCLOTRIMAZOLE CREAM [PROFICIENT RX LP]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MCLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP]1
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XCLOTRIMAZOLE CREAM [REBEL DISTRIBUTORS CORP]1
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XCLOTRIMAZOLE CREAM [PROFICIENT RX LP]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
45802-434CLOTRIMAZOLE CREAM [PADAGIS ISRAEL PHARMACEUTICALS LTD]7Current NDC, Legacy NDC, 4 package rows20240910_3dcd0158-ec51-4fa7-a26a-02c2926156c0.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 8 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ANTIFUNGALMICONAZOLEVIVE HEALTH LLC30dca43e-e6c4-8107-e063-6394a90a2b972026-07-01WarningsExact identifier
application number: M005
Fungi Nail Everyday Antifungal PowderTOLNAFTATEKramer Laboratories8ed1a08a-3019-4564-968f-154e659c05e12026-07-01WarningsExact identifier
application number: M005
Terpenicol Antifungal SolutionMICONAZOLE NITRATEBlaine Labs Inc.f17ef2cd-5923-4df5-a7fe-aeef167e1e862026-07-01WarningsExact identifier
application number: M005
LUMUMU TOENAIL REPAIR PENUNDECYLENIC ACID 25% TOENAIL REPAIR PENWenzhou Yuyuan Pharmaceutical Co., Ltd.55763ee1-a775-731c-e063-6394a90a8f4c2026-06-30WarningsExact identifier
application number: M005
Kopa Haiku Ringworm Treatment CreamMICONAZOLE NITRATE 2%Trovina Co. Ltd52cef8ec-6578-5e80-e063-6294a90ab4232026-06-30WarningsExact identifier
application number: M005
Tinea Versicolor Treatment CreamCLOTRIMAZOLEBeautivity LLC32d71d7e-3c78-6b63-e063-6294a90adaed2026-06-29WarningsExact identifier
application number: M005
Tinea Versicolor Treatment BarCLOTRIMAZOLEBeautivity LLC33612382-2f12-e9f6-e063-6394a90aaee42026-06-29WarningsExact identifier
application number: M005
Tinea Versicolor Treatment KitCLOTRIMAZOLEBeautivity LLC3361d9a2-daf6-7749-e063-6294a90a36532026-06-29WarningsExact identifier
application number: M005
Hermon Clotrimazole antifungal treatment creamCLOTRIMAZOLE 1%Beautivity LLC3c9bd942-49c6-cada-e063-6394a90a31662026-06-29WarningsExact identifier
application number: M005
Initial Drug Listing - Hermon Athletes Foot 1% Tolnaftate CreamTOLNAFTATE 1%Beautivity LLC4141cca0-1650-6e00-e063-6394a90a13e32026-06-29WarningsExact identifier
application number: M005
Athlete Foot Treatment KitTERBINAFINE HYDROCHLORIDE, TOLNAFTATEBeautivity LLC3b3aa69f-4e73-cabc-e063-6294a90ab65b2026-06-29WarningsExact identifier
application number: M005
Athlete Foot CreamTERBINAFINE HYDROCHLORIDEBeautivity LLC3b2c1d7f-32c3-aa3b-e063-6394a90a62672026-06-29WarningsExact identifier
application number: M005
Hermon Clotrimazole antifungal soap. barCLOTRIMAZOLE 1%Beautivity LLC3cdcf8cc-510c-6115-e063-6294a90ac3ea2026-06-29WarningsExact identifier
application number: M005
Clotrimazole antifungal treatment kitCLOTRIMAZOLE 1%Beautivity LLC3ceec52e-4089-9eb0-e063-6294a90ad52a2026-06-29WarningsExact identifier
application number: M005
Ringworm Treatment CreamMICONAZOLE NITRATE 2%Beautivity LLC4805462b-aec6-78fe-e063-6394a90ae0662026-06-29WarningsExact identifier
application number: M005
Hermon Athletes foot Tolnaftate 1% kitTOLNAFTATE 1% KITBeautivity LLC4142f490-c4b5-a9f3-e063-6394a90ab75e2026-06-29WarningsExact identifier
application number: M005
Aosorw Antifungal CreamMICONAZOLE NITRATE 2%SpineStatus LLC31f4b0eb-b8aa-7ccb-e063-6394a90ad9812026-06-29WarningsExact identifier
application number: M005
VORVITA Nail HardenerPANTHENOL,HYALURONIC ACIDHK Vorvita Technology Co., Limited51d5d3c7-ca25-3ee5-e063-6294a90a3a052026-06-26WarningsExact identifier
application number: M005
natouchMICONAZOLENatouch LLC55210a9d-6c47-4fc7-e063-6294a90a36532026-06-25WarningsExact identifier
application number: M005
YEARCHOICE Fungal Nail Repair PenFUNGAL NAIL REPAIR PENGuangzhou Jingliang Cosmetics Co., Ltd.5500b582-0641-498d-e063-6394a90a3c582026-06-24WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309367clotrimazole 1 % Topical CreamPSNc0f58a0d-a304-41f9-bbdf-c2e488230cf014
309367clotrimazole 10 MG/ML Topical CreamSCDc0f58a0d-a304-41f9-bbdf-c2e488230cf014
309367clotrimazole 1 % Topical CreamSYc0f58a0d-a304-41f9-bbdf-c2e488230cf014
309367clotrimazole 1 % Topical CreamPSNb63a3fe5-5684-41bc-ad6c-69c54e5b942d10
309367clotrimazole 10 MG/ML Topical CreamSCDb63a3fe5-5684-41bc-ad6c-69c54e5b942d10
309367clotrimazole 1 % Topical CreamSYb63a3fe5-5684-41bc-ad6c-69c54e5b942d10
309367clotrimazole 1 % Topical CreamPSN3dcd0158-ec51-4fa7-a26a-02c2926156c08
309367clotrimazole 10 MG/ML Topical CreamSCD3dcd0158-ec51-4fa7-a26a-02c2926156c08
309367clotrimazole 1 % Topical CreamSY3dcd0158-ec51-4fa7-a26a-02c2926156c08
309367clotrimazole 1 % Topical CreamPSNeeb241a3-93ee-4b74-8cbb-65713d15e7e07
309367clotrimazole 10 MG/ML Topical CreamSCDeeb241a3-93ee-4b74-8cbb-65713d15e7e07
309367clotrimazole 1 % Topical CreamSYeeb241a3-93ee-4b74-8cbb-65713d15e7e07
309367clotrimazole 1 % Topical CreamPSN627375fb-2f20-16bc-e053-2a91aa0a15425
309367clotrimazole 10 MG/ML Topical CreamSCD627375fb-2f20-16bc-e053-2a91aa0a15425
309367clotrimazole 1 % Topical CreamSY627375fb-2f20-16bc-e053-2a91aa0a15425
309367clotrimazole 1 % Topical CreamPSN54241254-1d9a-346a-e054-00144ff8d46c4
309367clotrimazole 10 MG/ML Topical CreamSCD54241254-1d9a-346a-e054-00144ff8d46c4
309367clotrimazole 1 % Topical CreamSY54241254-1d9a-346a-e054-00144ff8d46c4
309367clotrimazole 1 % Topical CreamPSN706f3bb5-1ada-420a-9d8e-79aea018df531
309368clotrimazole 1 % Vaginal CreamPSNef0b0fca-40c4-4bb6-8a0a-9c3ff717866f1
309367clotrimazole 10 MG/ML Topical CreamSCD706f3bb5-1ada-420a-9d8e-79aea018df531
309368clotrimazole 10 MG/ML Vaginal CreamSCDef0b0fca-40c4-4bb6-8a0a-9c3ff717866f1
309367clotrimazole 1 % Topical CreamSY706f3bb5-1ada-420a-9d8e-79aea018df531
309368clotrimazole 1 % Vaginal CreamSYef0b0fca-40c4-4bb6-8a0a-9c3ff717866f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-434-01458020434011 TUBE in 1 CARTON (45802-434-01) > 15 g in 1 TUBE1 tube2011-06-030000-00-00NoNoCurrent
45802-434-11458020434111 TUBE in 1 CARTON (45802-434-11) / 28 g in 1 TUBE1 tube2011-06-092027-04-30NoNoCurrent