TheraPlus

Product NDC
55621-003
11-digit product format
556210003
Labeler code
55621
Product ID
55621-003_08ad180e-e87c-ba6f-e063-6394a90a2bc7
Type
HUMAN OTC DRUG
Nonproprietary name
CLOTRIMAZOLE
Dosage form
CREAM
Route
TOPICAL
Labeler
Zhejiang Jingwei Pharmaceutical Co., Ltd.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-03-01
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
TheraPlus
Brand name suffix
Plus
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
de75179d-1889-4823-9f39-4bebdf185d76Available 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
55621-003-01TheraPlusPlus35 g in 1 TUBECREAM355

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLOTRIMAZOLEACTIVE INGREDIENTG07GZ97H65THERAPLUS PLUS (CLOTRIMAZOLE) CREAM [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]2
CLOTRIMAZOLEACTIVE MOIETYG07GZ97H65THERAPLUS PLUS (CLOTRIMAZOLE) CREAM [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTHERAPLUS PLUS (CLOTRIMAZOLE) CREAM [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]2
GLYCERYL STEARATE SEINACTIVE INGREDIENTFCZ5MH785ITHERAPLUS PLUS (CLOTRIMAZOLE) CREAM [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]2
LAURETH-23INACTIVE INGREDIENTN72LMW566GTHERAPLUS PLUS (CLOTRIMAZOLE) CREAM [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TTHERAPLUS PLUS (CLOTRIMAZOLE) CREAM [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPTHERAPLUS PLUS (CLOTRIMAZOLE) CREAM [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UTHERAPLUS PLUS (CLOTRIMAZOLE) CREAM [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHTHERAPLUS PLUS (CLOTRIMAZOLE) CREAM [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTHERAPLUS PLUS (CLOTRIMAZOLE) CREAM [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]2
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YTHERAPLUS PLUS (CLOTRIMAZOLE) CREAM [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]2
WATERINACTIVE INGREDIENT059QF0KO0RTHERAPLUS PLUS (CLOTRIMAZOLE) CREAM [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55621-003THERAPLUS PLUS (CLOTRIMAZOLE) CREAM [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]5Current NDC, Legacy NDC, 1 package rows20231101_de75179d-1889-4823-9f39-4bebdf185d76.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 35 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ONIADBA Fungal Nail Treatment SwabsTOLNAFTATE,UNDECYLENIC ACIDShenzhen Boyimei Technology Co., Ltd.3baa99ab-6d22-8d7d-e063-6294a90af3e82025-08-05WarningsExact identifier
application number: M005
MICONAZOLE Nitrate 2% Cream ANTIFUNGALMICONAZOLE NITRATEPreferred Pharmaceuticals Inc.cca84334-2e2d-4991-9d1e-d5b7c9ffd3922025-08-01WarningsExact identifier
application number: M005
RoyceDerm CoolDefense Refreshing Shower GelTOLNAFTATE 1.0%RoyceDerm LLC3b3216d6-8cc8-ea89-e063-6294a90ab6912025-07-31WarningsExact identifier
application number: M005
SUNMARK MICONAZOLE NITRATE antifungalMICONAZOLE NITRATEStrategic Sourcing Services LLC7c15d95a-5b89-4789-8c91-3f61d7ec77072025-07-30WarningsExact identifier
application number: M005
AntifungalMICONAZOLE NITRATEAdvanced Rx LLCe13eb653-3916-444a-ae86-1738c0308b792025-07-28WarningsExact identifier
application number: M005
Meridian Unwrapped Antibacterial DeodorantBENZETHONIUM CHLORIDEYangzhou Hongshengding Chemical Co.,Ltd.a2b9570f-312c-4f46-994d-efe057b247aa2025-07-28WarningsExact identifier
application number: M005
Meridian Antibacterial DeodorantBENZETHONIUM CHLORIDEYangzhou Hongshengding Chemical Co.,Ltd.b41b130f-48fd-47d4-a94e-74433ae44de22025-07-28WarningsExact identifier
application number: M005
Rugby Clotrimazole Antifungal CreamCLOTRIMAZOLEPreferred Pharmaceuticals Inc.bd567e91-7152-4612-83e0-8e8a00c2d2c52025-07-25WarningsExact identifier
application number: M005
HongocuraUNDECYLENIC ACID, ZINC UNDECYLENATEMENPER DISTRIBUTORS, INC.c69b735e-0ffe-4328-bd9f-3c1ac6798c082025-07-22WarningsExact identifier
application number: M005
Hongocura PinceladasUNDECYLENIC ACIDMenper Distributors, Inc.4b9a3a70-d646-47c6-b969-5c4d759d23a42025-07-22WarningsExact identifier
application number: M005
Hongocura MUNDECYLENIC ACIDMENPER DISTRIBUTORS, INC.b4adb7b0-59b4-4b3c-9b0e-1869bb5431742025-07-22WarningsExact identifier
application number: M005
Hongocura SUNDECYLENIC ACIDMENPER DISTRIBUTORS, INC.4a21f371-bfc1-4e66-af16-55b3283872b72025-07-22WarningsExact identifier
application number: M005
FifthPulse Miconazole Nitrate Cream 1ozMICONAZOLE NITRATEFront Pharmaceutical PLC3a37a3a8-9d05-926c-e063-6294a90a9ed82025-07-18WarningsExact identifier
application number: M005
FifthPulse Miconazole Nitrate Cream 4ozMICONAZOLE NITRATEFront Pharmaceutical PLC3a382b79-dde9-dde0-e063-6294a90a53bb2025-07-18WarningsExact identifier
application number: M005
FifthPulse clotrimazole cream 4ozCLOTRIMAZOLE 1%Front Pharmaceutical PLC3a389093-48f2-29cb-e063-6294a90ada372025-07-18WarningsExact identifier
application number: M005
PHARMBANNER Tea Tree Oil Antifungal Soap.TEA TREE OIL ANTIFUNGAL SOAP.Shenzhen Xinxin Yunhai Technology Co., Ltd.3a0860b0-346e-7024-e063-6394a90ace812025-07-16WarningsExact identifier
application number: M005
TopCare AntifungalCLOTRIMAZOLETopco Associates LLC6757eb2a-73e0-4bd0-a332-5713fdf3445d2025-07-16WarningsExact identifier
application number: M005
UpandUp ClotrimazoleCLOTRIMAZOLETarget Corporationcb2b7d38-9988-493b-9843-56c2f59eed2f2025-07-16WarningsExact identifier
application number: M005
Jock ItchCLOTRIMAZOLETARGET Corporation1ae551e7-69de-4eef-b4f7-5e1a880e631d2025-07-16WarningsExact identifier
application number: M005
Athletes FootCLOTRIMAZOLEFRED'S, INC.d2d8f44e-2dfa-446b-855e-86e0d6d2d0df2025-07-15WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309367clotrimazole 1 % Topical CreamPSNde75179d-1889-4823-9f39-4bebdf185d765
309367clotrimazole 10 MG/ML Topical CreamSCDde75179d-1889-4823-9f39-4bebdf185d765
309367clotrimazole 1 % Topical CreamSYde75179d-1889-4823-9f39-4bebdf185d765

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55621-003-015562100030135 g in 1 TUBE (55621-003-01) 35 g2013-03-010000-00-00NoNoCurrent