FDA.reportPublic FDA data

Clotrimazole

Product NDC
69396-001
11-digit product format
693960001
Labeler code
69396
Product ID
69396-001_3d0eea58-f83c-2b5d-e063-6294a90a1c05
Type
HUMAN OTC DRUG
Nonproprietary name
Clotrimazole
Dosage form
CREAM
Route
TOPICAL
Labeler
TRIFECTA PHARMACEUTICALS USA LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-03-10
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
6b74d405-42d6-4c46-ba78-3007d1e8ffb8Available 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
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69396-001-04Clotrimazole1 in 1 BOXCREAM124
69396-001-04Clotrimazole113.4 g in 1 TUBECREAM113.424
69396-001-05Clotrimazole15 g in 1 TUBECREAM1524
69396-001-05Clotrimazole1 in 1 BOXCREAM124
69396-001-09Clotrimazole0.9 g in 1 PACKAGECREAM0.924
69396-001-09Clotrimazole144 in 1 BOXCREAM14424
69396-001-10Clotrimazole30 g in 1 TUBECREAM3024
69396-001-10Clotrimazole10 in 1 BOXCREAM1024
69396-001-20Clotrimazole28.4 g in 1 TUBECREAM28.424
69396-001-20Clotrimazole1 in 1 BOXCREAM124
69396-001-33Clotrimazole3 in 1 BOXCREAM324
69396-001-33Clotrimazole30 g in 1 TUBECREAM3024
69396-001-44Clotrimazole4 in 1 BOXCREAM424
69396-001-44Clotrimazole30 g in 1 TUBECREAM3024
69396-001-55Clotrimazole5 in 1 BOXCREAM524
69396-001-55Clotrimazole28.4 g in 1 TUBECREAM28.424
69396-001-66Clotrimazole30 g in 1 TUBECREAM3024
69396-001-66Clotrimazole4 in 1 BOXCREAM424

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69396-001-05GM - Gram69396-0010e552ddd-b14e-48ef-bc6b-2b3ad31fca8e12025-01-14
69396-001-20GM - Gram69396-0012dd0887e-5db0-4e7f-a99f-38477bb04dd012019-04-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLOTRIMAZOLEACTIVE INGREDIENTG07GZ97H65CLOTRIMAZOLE CREAM [TRIFECTA PHARMACEUTICALS USA LLC]5
CLOTRIMAZOLEACTIVE MOIETYG07GZ97H65CLOTRIMAZOLE CREAM [TRIFECTA PHARMACEUTICALS USA LLC]5
DIMETHYL SULFOXIDEINACTIVE INGREDIENTYOW8V9698HCLOTRIMAZOLE CREAM [TRIFECTA PHARMACEUTICALS USA LLC]5
ETHYLPARABENINACTIVE INGREDIENT14255EXE39CLOTRIMAZOLE CREAM [TRIFECTA PHARMACEUTICALS USA LLC]5
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCLOTRIMAZOLE CREAM [TRIFECTA PHARMACEUTICALS USA LLC]5
GLYCERYL STEARATE SEINACTIVE INGREDIENTFCZ5MH785ICLOTRIMAZOLE CREAM [TRIFECTA PHARMACEUTICALS USA LLC]5
LAURETH-23INACTIVE INGREDIENTN72LMW566GCLOTRIMAZOLE CREAM [TRIFECTA PHARMACEUTICALS USA LLC]5
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPCLOTRIMAZOLE CREAM [TRIFECTA PHARMACEUTICALS USA LLC]5
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UCLOTRIMAZOLE CREAM [TRIFECTA PHARMACEUTICALS USA LLC]5
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YCLOTRIMAZOLE CREAM [TRIFECTA PHARMACEUTICALS USA LLC]5
WATERINACTIVE INGREDIENT059QF0KO0RCLOTRIMAZOLE CREAM [TRIFECTA PHARMACEUTICALS USA LLC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-001CLOTRIMAZOLE CREAM [TRIFECTA PHARMACEUTICALS USA LLC]22Current NDC, Legacy NDC, 18 package rows20250210_6b74d405-42d6-4c46-ba78-3007d1e8ffb8.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 48 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EVERLIT CARE Hand SanitizerETHYL ALCOHOLEVERLIT GLOBAL INC.b9909c59-02e7-4d6c-aa2b-206f1ab4d02c2023-11-14WarningsExact identifier
application number: M005
FLUSH Maximum Strength Antifungal formulaUNDECYLENIC ACIDTriple Point Group, LLC1d9e56ef-c7c9-4aff-ab9e-b163e566e3d52023-11-11WarningsExact identifier
application number: M005
SIMPLY VITAL Antifungal CreamCLOTRIMAZOLEALPHA PLANTS INCd3842de3-0d13-4dc2-920b-90a4b822bbb82023-11-11WarningsExact identifier
application number: M005
CLARUS AC Antifungal SolutionTOLNAFTATEClinical Therapeutic Solutions28ab9f1b-65cd-4405-a9a3-f3c9b836693d2023-11-10WarningsExact identifier
application number: M005
Signature Black Bottle Tea Tree Antifungal Foot and Body WashTOLNAFTATERestoration Rockstar, Llc (dba: Kroning Signature Black Bottle)2c966d97-30f5-4942-b64d-742884ce6a2f2023-11-10WarningsExact identifier
application number: M005
Smooth Gator Fungus EliminatorCLOTRIMAZOLESmooth Gator, LLC262b04f5-1b5d-4c67-a557-01f8b17113022023-11-10WarningsExact identifier
application number: M005
TOLNAFTATE ANTIFUNGALTOLNAFTATEGeri-Care Pharmaceuticals, Corpf9e60430-eec1-4bc2-9522-eb5aa527d90a2023-11-08WarningsExact identifier
application number: M005
Terrasil Jock Itch Treatment Maximum StrengthCLOTRIMAZOLEAidance Skincare & Topical Solutions, LLCc62fbf23-5d19-44ab-9c1a-e9b803192ed02023-11-08WarningsExact identifier
application number: M005
terrasil The Fungal Solution KitCLOTRIMAZOLEAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions9a5eb581-62a2-41fe-a174-e852fc47e2352023-11-08WarningsExact identifier
application number: M005
EmoniNail AntifungalUNDECYLENIC ACIDGG Healthworks Inc.84ace47a-d3ae-4735-87b6-dbbf1c40cf542023-11-06WarningsExact identifier
application number: M005
CIDACIN Antifungal TreatmentTOLNAFTATEPedicis Research LLCbd53a9e3-65c8-4834-8e23-a2a928b83a662023-11-05WarningsExact identifier
application number: M005
MacerRx WebMICONAZOLE NITRATEClinical Therapeutic Solutionsc9327f41-10f1-41f3-855b-838c701d67672023-11-05WarningsExact identifier
application number: M005
CLARUS AntifungalTOLNAFTATEClinical Therapeutic Solutions7e8897ff-67d1-4336-866e-cb76a36edddc2023-11-05WarningsExact identifier
application number: M005
CLARUS AntifungalTOLNAFTATEClinical Therapeutic Solutions308a91d1-3511-4e2d-a62f-a31d77d70e062023-11-05WarningsExact identifier
application number: M005
Human Science Antifungal Foot CareUNDECYLENIC ACIDHUMAN SCIENCE, LLC26b2519b-7d7b-4b33-b5d6-a41fe6f735382023-11-05WarningsExact identifier
application number: M005
HomeHealth AntifungalTOLNAFTATEHome Health895cd24c-3f78-4e2e-bf98-8bb6605798da2023-11-05WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEProficient Rx LP800a9dab-d287-427e-af6d-26996e0def412023-11-01WarningsExact identifier
application number: M005
Povidone IodinePOVIDONE-IODINEDr Radows58e1757c-45ce-455e-bd64-a9e99cd3680f2023-10-30WarningsExact identifier
application number: M005
JOCK-EZECLOTRIMAZOLEBentlin Products LLCd3ff5bfb-2e0f-4daa-84b3-4a3016ca92802023-10-30WarningsExact identifier
application number: M005
TheraPlus PlusCLOTRIMAZOLEZhejiang Jingwei Pharmaceutical Co., Ltd.de75179d-1889-4823-9f39-4bebdf185d762023-10-27WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309367clotrimazole 1 % Topical CreamPSN6b74d405-42d6-4c46-ba78-3007d1e8ffb824
309367clotrimazole 10 MG/ML Topical CreamSCD6b74d405-42d6-4c46-ba78-3007d1e8ffb824
309367clotrimazole 1 % Topical CreamSY6b74d405-42d6-4c46-ba78-3007d1e8ffb824
309367clotrimazole 1 % Topical CreamPSN800a9dab-d287-427e-af6d-26996e0def413
309367clotrimazole 10 MG/ML Topical CreamSCD800a9dab-d287-427e-af6d-26996e0def413
309367clotrimazole 1 % Topical CreamSY800a9dab-d287-427e-af6d-26996e0def413
309367clotrimazole 1 % Topical CreamPSN0052992a-819c-4c55-bd88-201a09a3573a1
309367clotrimazole 10 MG/ML Topical CreamSCD0052992a-819c-4c55-bd88-201a09a3573a1
309367clotrimazole 1 % Topical CreamSY0052992a-819c-4c55-bd88-201a09a3573a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69396-001-04693960001041 TUBE in 1 BOX (69396-001-04) / 113.4 g in 1 TUBE1 tube2022-05-030000-00-00NoNoCurrent
69396-001-05693960001051 TUBE in 1 BOX (69396-001-05) / 15 g in 1 TUBE1 tube2016-08-230000-00-00NoNoCurrent
69396-001-0969396000109144 PACKAGE in 1 BOX (69396-001-09) / .9 g in 1 PACKAGE144 package2022-03-090000-00-00NoNoCurrent
69396-001-106939600011010 TUBE in 1 BOX (69396-001-10) / 30 g in 1 TUBE10 tube2024-07-03NoNoCurrent
69396-001-20693960001201 TUBE in 1 BOX (69396-001-20) / 28.4 g in 1 TUBE1 tube2015-03-100000-00-00NoNoCurrent
69396-001-33693960001333 TUBE in 1 BOX (69396-001-33) / 30 g in 1 TUBE3 tube2024-06-10NoNoCurrent
69396-001-44693960001444 TUBE in 1 BOX (69396-001-44) / 30 g in 1 TUBE4 tube2024-11-06NoNoCurrent
69396-001-55693960001555 TUBE in 1 BOX (69396-001-55) / 28.4 g in 1 TUBE5 tube2023-11-06NoNoCurrent
69396-001-66693960001664 TUBE in 1 BOX (69396-001-66) / 30 g in 1 TUBE4 tube2024-03-18NoNoCurrent