FDA.reportPublic FDA data

Thera plus Antifungal Clotrimazole

Product NDC
80684-039
11-digit product format
806840039
Labeler code
80684
Product ID
80684-039_08a0ce90-0c11-15f4-e063-6294a90a6ca7
Type
HUMAN OTC DRUG
Nonproprietary name
CLOTRIMAZOLE
Dosage form
CREAM
Route
TOPICAL
Labeler
FOURSTAR GROUP USA, INC.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-01-30
Substance
CLOTRIMAZOLE
Active strength
10 mg/g
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
Thera plus Antifungal Clotrimazole
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOTRIMAZOLE10 mg/g

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
1265be99-8922-4b76-bd63-19bfb42c3896Available 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
80684-039-01Thera plus Antifungal Clotrimazole14 g in 1 TUBECREAM142
80684-039-01Thera plus Antifungal Clotrimazole1 in 1 BOXCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80684-039THERA PLUS ANTIFUNGAL CLOTRIMAZOLE (CLOTRIMAZOLE) CREAM [FOURSTAR GROUP USA, INC.]2Current NDC, Legacy NDC, 2 package rows20231027_1265be99-8922-4b76-bd63-19bfb42c3896.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 1 of 52 · 1,021 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Defense Antifungal Medicated BarTOLNAFTATEDefense Soap LLC812d78ea-a14a-e3a2-e053-2a91aa0a6ff52026-09-09WarningsExact identifier
application number: M005
Radthary GROIN ANTIFUNGAL CreamMICONAZOLE NITRATE 2% GROIN ANTIFUNGAL CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.5b1945f3-84ba-f3dc-e063-6294a90ab8a02026-09-09WarningsExact identifier
application number: M005
MedlineMICONAZOLE NITRATEMedline Industries, LP0d997d1d-8663-201f-e063-6394a90a285e2026-09-08WarningsExact identifier
application number: M005
Remedy Antifungal With OlivamineMICONAZOLE NITRATEMedline Industries, LP28c5183e-05b4-1754-e054-00144ff8d46c2026-09-08WarningsExact identifier
application number: M005
ClaravieMICONAZOLE NITRATE 2%Gentell LLC5afdc429-cb44-703c-e063-6294a90a971a2026-09-08WarningsExact identifier
application number: M005
HSENJT Antifungal CreamMICONAZOLE NITRATEHuizhou Haosen Trading Co., Ltd.5aa587f5-5ddf-542a-e063-6294a90a522b2026-09-07WarningsExact identifier
application number: M005
Inlifay ANTIFUNGALMICONAZOLE NITRATE 2% ANTIFUNGALJiangxi Yudexi Pharmaceutical Co., LTD4a832f39-ac11-d8b3-e063-6394a90acb392026-09-06WarningsExact identifier
application number: M005
Noicaky FUNGAL NAIL PatchesTOLNAFTATE 1% FUNGAL NAIL PATCHESWenzhou Yuyuan Pharmaceutical Co., Ltd.5adcc5f7-2d47-2ad7-e063-6294a90a48482026-09-06WarningsExact identifier
application number: M005
LIFE66II ANTIFUNGAL NAILUNDECYLENIC ACID 25% ANTIFUNGAL NAILWenzhou Yuyuan Pharmaceutical Co., Ltd.5ab83796-0780-3b58-e063-6394a90a2e4e2026-09-05WarningsExact identifier
application number: M005
FGPER Topical Antifungal PenUNDECYLENIC ACIDGuangzhou ChuanMa International Trading Co.,Ltd.5abdcbff-6ab1-2f0a-e063-6294a90a57ef2026-09-05WarningsExact identifier
application number: M005
AOUGK SALICYLIC ACID WART REMOVERSALICYLIC ACIDGuangzhou ChuanMa International Trading Co.,Ltd.5ac88b51-b46c-5cc6-e063-6394a90af9e52026-09-05WarningsExact identifier
application number: M005
Jock Itch PowderMICONAZOLE NITRATEPremier Brands of America Inc5aaacc88-6752-ab47-e063-6394a90af7cd2026-09-04WarningsExact identifier
application number: M005
ANTIFUNGAL BODY WASHTOLNAFTATEGuangzhou ChuanMa International Trading Co.,Ltd.5a695043-f776-df5a-e063-6394a90ac2742026-09-01WarningsExact identifier
application number: M005
KetoconClear CreamKETOCONAZOLEGuangzhou Shunfei Network Technology Co., Ltd.5a54eebe-5b4a-28dd-e063-6294a90a607f2026-08-31WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEInvaDerm Corporation5a5cfed9-0587-7bef-e063-6294a90a64bf2026-08-31WarningsExact identifier
application number: M005
Gembooxt RINGWORM CreamMICONAZOLE NITRATE, HYDROCORTISONEGuangdong Quadrant Ecological Technology Co., Ltd.464a33c3-6d16-0cfd-e063-6294a90abf4b2026-08-27WarningsExact identifier
application number: M005
DrAny NAIL FUNGUS TREATMENTUNDECYLENIC ACID, TOLNAFTATEHong Kong Juxin Negosyo Kag Komersyo Co., Limited59ef412b-fc7b-0a84-e063-6394a90abf252026-08-26WarningsExact identifier
application number: M005
Miconazole NitrateMICONAZOLE NITRATESun Pharmaceutical Industries, Inc.7fd4037e-d350-47b7-a7d9-a43b8e366fa02026-08-25WarningsExact identifier
application number: M005
WISH HAND SANITIZER pink dragon blossomALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA593b3fbe-a8de-1c09-e063-6294a90adc692026-08-24WarningsExact identifier
application number: M005
Okkazhie WART REMOVER40% SALICYLIC ACIDGuangzhou Huixue Biotechnology Co., Ltd.59c2d759-d1e9-6c9d-e063-6294a90a04db2026-08-23WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309367clotrimazole 1 % Topical CreamPSN1265be99-8922-4b76-bd63-19bfb42c38962
309367clotrimazole 10 MG/ML Topical CreamSCD1265be99-8922-4b76-bd63-19bfb42c38962
309367clotrimazole 1 % Topical CreamSY1265be99-8922-4b76-bd63-19bfb42c38962

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80684-039-01806840039011 TUBE in 1 BOX (80684-039-01) / 14 g in 1 TUBE1 tube2022-01-300000-00-00NoNoCurrent