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 24 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FortiniaCLOTRIMAZOLEThe Podiatree Company60ba6f8a-8617-d4f6-e053-2991aa0a4a712026-01-08WarningsExact identifier
application number: M005
RoyceDerm Anti fungal RELIEF creamSALICYLIC ACID 2%RoyceDerm LLC47ec6277-e40f-af82-e063-6294a90ac8c12026-01-08WarningsExact identifier
application number: M005
BBlove ALCOHOL WIPESBBLOVE ALCOHOL WIPESShenzhen Shierjie Biological Engineering Co., LTD1a451616-b16e-8aa7-e063-6294a90a26a12026-01-07WarningsExact identifier
application number: M005
Wet wipesWET WIPESShenzhen Shierjie Biological Engineering Co., LTD273b3ae2-6dec-31a4-e063-6294a90aca892026-01-07WarningsExact identifier
application number: M005
Bee Venom Fungal Nail Treatment LiquidBEE VENOM FUNGAL NAIL TREATMENTShenzhen Earth Surface Trading Co., Ltd.47c37468-ba5c-0d11-e063-6294a90ac5542026-01-06WarningsExact identifier
application number: M005
ProBliva Anti Fungal Shampoo.ANTIFUNGALCAVTECH HOLDING LLC47af9ff8-5d5c-4524-e063-6394a90ac91f2026-01-05WarningsExact identifier
application number: M005
Beauty Creations Pink Halo Hand Sanitizer MistETHYL ALCOHOLNantong Health & Beyond Hygienic Products Inc.dda9f4cb-e431-4164-be61-0daf1a86d10f2026-01-04WarningsExact identifier
application number: M005
FUNGAL NAIL PATCHESUNDECYLENIC ACIDGuangzhou Hechuang Commercial Service Co.,Ltd.477c971d-829f-5040-e063-6394a90a41e42026-01-03WarningsExact identifier
application number: M005
Nail Renovar PlusTOLNAFTATESOHM, Inc2c09925c-e63e-4d9b-8d76-b06bd2cba26c2026-01-02WarningsExact identifier
application number: M005
Natural Sense Full Body Cleansing TowelCLEANSING TOWELDr. Natural LLC4742eec4-b7a3-2c89-e063-6294a90a19fc2025-12-31WarningsExact identifier
application number: M005
Lasolex AGMICONAZOLE NITRATEPuretek Corporation4411142f-a8ec-c8c2-e063-6394a90aa25c2025-12-31WarningsExact identifier
application number: M005
Hermon Antifungal Stick1% CLOTRIMAZOLEBeautivity LLC474a5783-4488-034e-e063-6294a90a5de32025-12-31WarningsExact identifier
application number: M005
SnugZ Hand Sanitizing WipesHAND SANITIZING WIPESSnugZ/USA, LLCc5d9122a-2c67-2387-e053-2a95a90a2c3a2025-12-29WarningsExact identifier
application number: M005
Clotrimazole (Topical Solution), 1%CLOTRIMAZOLEPuro Pharma Inc.cb424fa8-3ed5-45cd-b03f-64675584b34e2025-12-27WarningsExact identifier
application number: M005
CLOTRIMAZOLECLOTRIMAZOLEGRAXCELL PHARMACEUTICAL, LLC.5f8ca6ad-cb25-1abf-e053-2a91aa0aca992025-12-25WarningsExact identifier
application number: M005
CuraNails Antifungal PenUNDECYLENIC ACID 25%Quality Discount Inc.3e641d36-72f6-4682-bd31-f7cd04d857f22025-12-25WarningsExact identifier
application number: M005
Opti-Nail 2-in-1TOLNAFTATEKramer Laboratoriesbc8a5492-8bd0-4c80-a270-e4958aeb5ed62025-12-23WarningsExact identifier
application number: M005
ProBliva Medicated Anti FungalANTIFUNGALCAVTECH HOLDING LLC46852aea-028c-71c2-e063-6394a90a80552025-12-22WarningsExact identifier
application number: M005
Terthon Clotrimazole 1% Antifungal CreamCLOTRIMAZOLE 1%SOLALIA LLC468f1b1b-f67d-8b98-e063-6294a90a7f452025-12-22WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEGranules USA, Inc.6e63e29a-eb50-1790-e053-2a91aa0a36162025-12-22WarningsExact 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