FungiFoam

Product NDC
49406-004
11-digit product format
494060004
Labeler code
49406
Product ID
49406-004_4c5c1f4d-1131-c3d0-e063-6394a90a88e2
Type
HUMAN OTC DRUG
Nonproprietary name
TOLNAFTATE
Dosage form
AEROSOL, FOAM
Route
TOPICAL
Labeler
The Tetra Corporation
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-07-13
Substance
TOLNAFTATE
Active strength
10 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage49406-00449406-004-30DDiscontinued by firm2026-10-16

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 21 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49406-004-75IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49406-004-30IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49406-004-75IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49406-004-30IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49406-004-75IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49406-004-30IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49406-004-75IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49406-004-30IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49406-004-30UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49406-004-75UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49406-004-30UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49406-004-75UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49406-004-30UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49406-004-75UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
FungiFoam
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE10 mg/mL

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1356533Internal RxNorm lookup
1356538Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2449e8e5-9d7e-4119-9e7a-378efe55f875Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
49406-004-302025-08-18FungiFoam ANTIFUNGAL
49406-004-752025-08-18FungiFoam ANTIFUNGAL
49406-004-302025-01-30FungiFoam ANTIFUNGAL
49406-004-752025-01-30FungiFoam ANTIFUNGAL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49406-004-30FungiFoam30 mL in 1 TUBEAEROSOL, FOAM3019
49406-004-30FungiFoam1 in 1 BOXAEROSOL, FOAM119
49406-004-75FungiFoam75 mL in 1 BOTTLEAEROSOL, FOAM7519
49406-004-75FungiFoam1 in 1 BOXAEROSOL, FOAM119

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49406-004-75ML - Milliliter49406-0043b9c5268-ecd0-43ac-8cb0-0c1e227c1fb612026-05-22

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOLNAFTATEACTIVE INGREDIENT06KB629TKVFUNGIFOAM (TOLNAFTATE) AEROSOL, FOAM [THE TETRA CORPORATION]5
TOLNAFTATEACTIVE MOIETY06KB629TKVFUNGIFOAM (TOLNAFTATE) AEROSOL, FOAM [THE TETRA CORPORATION]5
ALKYL (C12-15) BENZOATEINACTIVE INGREDIENTA9EJ3J61HQFUNGIFOAM (TOLNAFTATE) AEROSOL, FOAM [THE TETRA CORPORATION]5
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KFUNGIFOAM (TOLNAFTATE) AEROSOL, FOAM [THE TETRA CORPORATION]5
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311FUNGIFOAM (TOLNAFTATE) AEROSOL, FOAM [THE TETRA CORPORATION]5
CETEARETH-25INACTIVE INGREDIENT8FA93U5T67FUNGIFOAM (TOLNAFTATE) AEROSOL, FOAM [THE TETRA CORPORATION]5
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SFUNGIFOAM (TOLNAFTATE) AEROSOL, FOAM [THE TETRA CORPORATION]5
DIETHYLENE GLYCOL MONOETHYL ETHERINACTIVE INGREDIENTA1A1I8X02BFUNGIFOAM (TOLNAFTATE) AEROSOL, FOAM [THE TETRA CORPORATION]5
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PFUNGIFOAM (TOLNAFTATE) AEROSOL, FOAM [THE TETRA CORPORATION]5
JOJOBA OILINACTIVE INGREDIENT724GKU717MFUNGIFOAM (TOLNAFTATE) AEROSOL, FOAM [THE TETRA CORPORATION]5
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TFUNGIFOAM (TOLNAFTATE) AEROSOL, FOAM [THE TETRA CORPORATION]5
POLYOXYL 20 CETOSTEARYL ETHERINACTIVE INGREDIENTYRC528SWUYFUNGIFOAM (TOLNAFTATE) AEROSOL, FOAM [THE TETRA CORPORATION]5
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MFUNGIFOAM (TOLNAFTATE) AEROSOL, FOAM [THE TETRA CORPORATION]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3FUNGIFOAM (TOLNAFTATE) AEROSOL, FOAM [THE TETRA CORPORATION]5
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APFUNGIFOAM (TOLNAFTATE) AEROSOL, FOAM [THE TETRA CORPORATION]5
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKFUNGIFOAM (TOLNAFTATE) AEROSOL, FOAM [THE TETRA CORPORATION]5
UREAINACTIVE INGREDIENT8W8T17847WFUNGIFOAM (TOLNAFTATE) AEROSOL, FOAM [THE TETRA CORPORATION]5
WATERINACTIVE INGREDIENT059QF0KO0RFUNGIFOAM (TOLNAFTATE) AEROSOL, FOAM [THE TETRA CORPORATION]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49406-004FUNGIFOAM (TOLNAFTATE) AEROSOL, FOAM [THE TETRA CORPORATION]15Current NDC, Legacy NDC, 4 package rows20231013_2449e8e5-9d7e-4119-9e7a-378efe55f875.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 48 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EVERLIT CARE Hand SanitizerETHYL ALCOHOLEVERLIT GLOBAL INC.b9909c59-02e7-4d6c-aa2b-206f1ab4d02c2023-11-14WarningsExact identifier
application number: M005
FLUSH Maximum Strength Antifungal formulaUNDECYLENIC ACIDTriple Point Group, LLC1d9e56ef-c7c9-4aff-ab9e-b163e566e3d52023-11-11WarningsExact identifier
application number: M005
SIMPLY VITAL Antifungal CreamCLOTRIMAZOLEALPHA PLANTS INCd3842de3-0d13-4dc2-920b-90a4b822bbb82023-11-11WarningsExact identifier
application number: M005
CLARUS AC Antifungal SolutionTOLNAFTATEClinical Therapeutic Solutions28ab9f1b-65cd-4405-a9a3-f3c9b836693d2023-11-10WarningsExact identifier
application number: M005
Signature Black Bottle Tea Tree Antifungal Foot and Body WashTOLNAFTATERestoration Rockstar, Llc (dba: Kroning Signature Black Bottle)2c966d97-30f5-4942-b64d-742884ce6a2f2023-11-10WarningsExact identifier
application number: M005
Smooth Gator Fungus EliminatorCLOTRIMAZOLESmooth Gator, LLC262b04f5-1b5d-4c67-a557-01f8b17113022023-11-10WarningsExact identifier
application number: M005
TOLNAFTATE ANTIFUNGALTOLNAFTATEGeri-Care Pharmaceuticals, Corpf9e60430-eec1-4bc2-9522-eb5aa527d90a2023-11-08WarningsExact identifier
application number: M005
Terrasil Jock Itch Treatment Maximum StrengthCLOTRIMAZOLEAidance Skincare & Topical Solutions, LLCc62fbf23-5d19-44ab-9c1a-e9b803192ed02023-11-08WarningsExact identifier
application number: M005
terrasil The Fungal Solution KitCLOTRIMAZOLEAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions9a5eb581-62a2-41fe-a174-e852fc47e2352023-11-08WarningsExact identifier
application number: M005
EmoniNail AntifungalUNDECYLENIC ACIDGG Healthworks Inc.84ace47a-d3ae-4735-87b6-dbbf1c40cf542023-11-06WarningsExact identifier
application number: M005
CIDACIN Antifungal TreatmentTOLNAFTATEPedicis Research LLCbd53a9e3-65c8-4834-8e23-a2a928b83a662023-11-05WarningsExact identifier
application number: M005
MacerRx WebMICONAZOLE NITRATEClinical Therapeutic Solutionsc9327f41-10f1-41f3-855b-838c701d67672023-11-05WarningsExact identifier
application number: M005
CLARUS AntifungalTOLNAFTATEClinical Therapeutic Solutions7e8897ff-67d1-4336-866e-cb76a36edddc2023-11-05WarningsExact identifier
application number: M005
CLARUS AntifungalTOLNAFTATEClinical Therapeutic Solutions308a91d1-3511-4e2d-a62f-a31d77d70e062023-11-05WarningsExact identifier
application number: M005
Human Science Antifungal Foot CareUNDECYLENIC ACIDHUMAN SCIENCE, LLC26b2519b-7d7b-4b33-b5d6-a41fe6f735382023-11-05WarningsExact identifier
application number: M005
HomeHealth AntifungalTOLNAFTATEHome Health895cd24c-3f78-4e2e-bf98-8bb6605798da2023-11-05WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEProficient Rx LP800a9dab-d287-427e-af6d-26996e0def412023-11-01WarningsExact identifier
application number: M005
Povidone IodinePOVIDONE-IODINEDr Radows58e1757c-45ce-455e-bd64-a9e99cd3680f2023-10-30WarningsExact identifier
application number: M005
JOCK-EZECLOTRIMAZOLEBentlin Products LLCd3ff5bfb-2e0f-4daa-84b3-4a3016ca92802023-10-30WarningsExact identifier
application number: M005
TheraPlus PlusCLOTRIMAZOLEZhejiang Jingwei Pharmaceutical Co., Ltd.de75179d-1889-4823-9f39-4bebdf185d762023-10-27WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1356538FungiFoam 1 % Topical FoamPSN2449e8e5-9d7e-4119-9e7a-378efe55f87519
1356533tolnaftate 1 % Topical FoamPSN2449e8e5-9d7e-4119-9e7a-378efe55f87519
1356538tolnaftate 10 MG/ML Topical Foam [Fungifoam]SBD2449e8e5-9d7e-4119-9e7a-378efe55f87519
1356533tolnaftate 10 MG/ML Topical FoamSCD2449e8e5-9d7e-4119-9e7a-378efe55f87519
1356538FungiFoam 1 % Topical FoamSY2449e8e5-9d7e-4119-9e7a-378efe55f87519
1356538Fungifoam 10 MG/ML Topical FoamSY2449e8e5-9d7e-4119-9e7a-378efe55f87519
1356533tolnaftate 1 % Topical FoamSY2449e8e5-9d7e-4119-9e7a-378efe55f87519

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49406-004-30494060004301 TUBE in 1 BOX (49406-004-30) > 30 mL in 1 TUBE1 tube2020-07-130000-00-00NoNoCurrent
49406-004-75494060004751 BOTTLE in 1 BOX (49406-004-75) / 75 mL in 1 BOTTLE1 bottle2020-07-130000-00-00NoNoCurrent