FDA.reportPublic FDA data

Thera plus Antifungal Tolnaftate

Product NDC
80684-040
11-digit product format
806840040
Labeler code
80684
Product ID
80684-040_08a0d819-d9c5-15e9-e063-6294a90acb44
Type
HUMAN OTC DRUG
Nonproprietary name
TOLNAFTATE
Dosage form
CREAM
Route
TOPICAL
Labeler
FOURSTAR GROUP USA, INC.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-01-30
Substance
TOLNAFTATE
Active strength
10 mg/g
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
Thera plus Antifungal Tolnaftate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
06KB629TKVInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
103951Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c628dda8-7a6d-5f3a-e053-2995a90a35f8Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80684-040-01Thera plus Antifungal Tolnaftate14 g in 1 TUBECREAM142
80684-040-01Thera plus Antifungal Tolnaftate1 in 1 BOXCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80684-040THERA PLUS ANTIFUNGAL TOLNAFTATE (TOLNAFTATE) CREAM [FOURSTAR GROUP USA, INC.]2Current NDC, Legacy NDC, 2 package rows20231027_c628dda8-7a6d-5f3a-e053-2995a90a35f8.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 37 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kroger Jock ItchCLOTRIMAZOLEKroger Companycc536b67-8b0b-4939-b0fb-9a9e4188c4e52025-07-08WarningsExact identifier
application number: M005
Rite Aid antifungal ringwormCLOTRIMAZOLERite Aid Corporation1ad7cd82-d01b-403e-a2c1-2302db2a78df2025-07-08WarningsExact identifier
application number: M005
ConazolMICONAZOLE NITRATELaboratorios Liomont, S.A. de C.V.84780538-8618-5750-e053-2a91aa0a60542025-07-07WarningsExact identifier
application number: M005
Clotrimazole 1% Athletes FootCLOTRIMAZOLESTRATEGIC SOURCING SERVICES LLC9aba1345-ef47-4951-8448-a43d6696b6162025-07-07WarningsExact identifier
application number: M005
sunmark antifungalTOLNAFTATEStrategic Sourcing Services LLCd0c30c74-9472-4978-9623-8c7dbeb994112025-07-07WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLESun Pharmaceutical Industries, Inc.a3a5cbf5-cabb-48d8-8877-74a97f7c0f572025-07-03WarningsExact identifier
application number: M005
OMZOK ANTIFUNGAL PENUNDECYLENIC ACID 25%Shenzhen Shandian Jingling Technology Co., Ltd.38edf699-93af-e550-e063-6294a90a368c2025-07-02WarningsExact identifier
application number: M005
meijer Athletes FootCLOTRIMAZOLEMeijer Distribution Incfdb15cd8-6726-4150-9b9d-6ef3ee01a5d22025-07-02WarningsExact identifier
application number: M005
meijer antifungalTOLNAFTATEMeijer Distribution Inc374af35a-b8bb-4784-bfc8-c3342de875ca2025-07-02WarningsExact identifier
application number: M005
Rexall Jock ItchCLOTRIMAZOLEDollar General11427a79-f262-4702-9b2e-ec1955a9b2da2025-07-02WarningsExact identifier
application number: M005
Rexall Athletes FootCLOTRIMAZOLEDollar General664579a1-a5b0-4a4c-bff6-4347f3e1d3bb2025-07-02WarningsExact identifier
application number: M005
Athletes Foot AntifungalTOLNAFTATEDollar General43fc473e-c1fd-4245-af38-2e9de5ad91dc2025-07-02WarningsExact identifier
application number: M005
SEFUDUN FUNGAL NAIL PATCHESGLYCERINShenzhen Shandian Jingling Technology Co., Ltd.38db97d6-27c8-da99-e063-6294a90aac662025-07-01WarningsExact identifier
application number: M005
Tolnaftate AntifungalTOLNAFTATESun Pharmaceutical Industries, Inc.fa16fa08-fbbd-4f45-b64a-9bffe78e88612025-07-01WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEGranules Pharmaceuticals Inc.1280353c-9f96-557e-e063-6294a90a10f92025-06-30WarningsExact identifier
application number: M005
MiconazoleMICONAZOLE NITRATEChain Drug Consortium, LLC246be926-79ea-4e0c-a3ef-2aa7fc3a52bf2025-06-30WarningsExact identifier
application number: M005
Miconazole NitrateANTIFUNGAL LIQUID CONTINUOUS SPRAYChain Drug Consortium, LLC7f6912a6-a576-4138-bd78-a075a7d240362025-06-27WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL LIQUID SPRAYRite Aid Corporationaee58c44-5dba-8acb-e053-2a95a90a23af2025-06-21WarningsExact identifier
application number: M005
Miconazole NitrateATHLETES FOOT POWDER SPRAY TALC FREERite Aid Corporation5e2f2372-4b79-4b6a-bdea-74289b1e20532025-06-21WarningsExact identifier
application number: M005
TolnaftateJOCK ITCH POWDERRite Aid Corporationb6968587-45c2-d2f8-e053-2a95a90a84012025-06-21WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
103951tolnaftate 1 % Topical CreamPSNc628dda8-7a6d-5f3a-e053-2995a90a35f82
103951tolnaftate 10 MG/ML Topical CreamSCDc628dda8-7a6d-5f3a-e053-2995a90a35f82
103951tolnaftate 1 % Topical CreamSYc628dda8-7a6d-5f3a-e053-2995a90a35f82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80684-040-01806840040011 TUBE in 1 BOX (80684-040-01) / 14 g in 1 TUBE1 tube2022-01-300000-00-00NoNoCurrent