FDA.reportPublic FDA data

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

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 Identifiers#

Field, Values table
FieldValues
UniiG07GZ97H65
Rxcui309367

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

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