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 firm2026-10-12

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 7 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EZBIORT 1% Tolnaftate Nail Essence with BiotinTOLNAFTATEGuangzhou Borderless Technology Co., Ltd.5629df38-1079-be4f-e063-6394a90a1c6a2026-07-09WarningsExact identifier
application number: M005
ZENJBUST Undecylenic Acid 25% Antifungal PenUNDECYLENIC ACID 25% ANTIFUNGAL PENShenzhen Xituo Electronics Co., Ltd563a6704-f662-3f08-e063-6394a90a43692026-07-09WarningsExact identifier
application number: M005
Antifungal CreamANTIFUNGALPreferred Pharmaceuticals Inc.c6098653-351a-449f-9b1a-0c617074f2b92026-07-08WarningsExact identifier
application number: M005
YEARCHOICE Fungal Nail RenewalFUNGAL NAIL RENEWALGuangzhou Jingliang Cosmetics Co., Ltd.561b650d-028c-687c-e063-6394a90a166a2026-07-08WarningsExact identifier
application number: M005
CAREALL ClotrimazoleCLOTRIMAZOLENew World Imports, Inc561d3e64-ab9c-1074-e063-6394a90a12982026-07-08WarningsExact identifier
application number: M005
Beautifier Life ALCOHOL WIPESBEAUTIFIER LIFE ALCOHOL WIPESShenzhen Shierjie Biological Engineering Co., LTD323ef469-e37c-00ad-e063-6394a90ab6f72026-07-08WarningsExact identifier
application number: M005
Folliculitis Treatment CreamMICONAZOLE NITRATE 2%Guangxi Keyun E-commerce Co., Ltd.5625652a-193d-0318-e063-6294a90a56f32026-07-08WarningsExact identifier
application number: M005
PureWellness FUNGAL FUSION Antifungal and Antimicrobial KitFUNGAL FUSION ANTIFUNGAL AND ANTIMICROBIAL KITPureWellness LLC25db8c55-0fa9-4795-8e05-4d3a7aaf01482026-07-06WarningsExact identifier
application number: M005
FUNGAL NAIL NIGHTTIME RENEWAL PATCHESTOLNAFTATE 1%100 KARMA INC3b9ab6e0-8773-f909-e063-6394a90ac1c92026-07-03WarningsExact identifier
application number: M005
TOENAIL FUNGUS TREATMENT25% UNDECYLENIC ACID100 KARMA INC3bb000dc-5e6c-b43b-e063-6394a90a63a92026-07-03WarningsExact identifier
application number: M005
Treatonic Toenail Fungus Treatment KitTOENAIL FUNGUS TREATMENT100 KARMA INC3d4bbc65-955f-8fd8-e063-6294a90adc442026-07-03WarningsExact identifier
application number: M005
Treatonic Nailtonic Repair Pens25% UNDECYLENIC ACID100 KARMA INC4a9c32b3-e78d-3c85-e063-6394a90a7bf22026-07-03WarningsExact identifier
application number: M005
Initial Treatonic FUNGAL NAIL RENEWAL PATCHESTOLNAFTATE 1%100 KARMA INC48e377b4-abb1-34cf-e063-6294a90a2ea32026-07-03WarningsExact identifier
application number: M005
Treatonic TONENAIL FUNGUS TREATONIC kit.25% UNDECYLENIC ACID AND TOLNAFTATE 1%100 KARMA INC4c197131-9ca8-6024-e063-6294a90aa9cb2026-07-03WarningsExact identifier
application number: M005
Treatonic Antifungal Pen25% UNDECYLENIC ACID100 KARMA INC52d89172-e8a7-70c0-e063-6294a90a35632026-07-03WarningsExact identifier
application number: M005
FUNGINIX ANTI-FUNGAL TREATMENTUNDECYLENIC ACIDThe Sisquoc Healthcare Corporation92db5433-5a1b-4cb9-b8eb-217c2a807a992026-07-02WarningsExact identifier
application number: M005
Anti DandruffKETOCONAZOLEGuangzhou ChuanMa International Trading Co.,Ltd.4cfe234c-49c0-18e8-e063-6294a90a0b1d2026-07-02WarningsExact identifier
application number: M005
Terpenicol Antifungal CreamMICONAZOLE NITRATEBlaine Labs Inc.9a4ec493-0b36-4bb8-aa9a-55cf5f79aeaa2026-07-01WarningsExact identifier
application number: M005
BeamBalm ANTIFUNGAL FOOT SOAKING PACKZINC UNDECYLENATE 5% ANTIFUNGAL FOOT SOAKING PACKJiangxi Yudexi Pharmaceutical Co., LTD50044b55-8553-ca52-e063-6394a90a0e542026-07-01WarningsExact identifier
application number: M005
VENROCKUNDECYLENIC ACIDGuangzhou Oupeng Cosmetics Co., Ltd.558af06e-6fe1-c926-e063-6394a90a738c2026-07-01WarningsExact 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