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 6 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FUNGAL NAIL TREATMENT kit .liquid.PSEUDOLARIX AMABILIS BARK 1%GETHSEMANE BRANCH CORPORATION56c93390-ee07-4f78-e063-6394a90add422026-07-17WarningsExact identifier
application number: M005
FUNGAL NAIL TREATMENT kit .cream.PSEUDOLARIX AMABILIS BARK 1%GETHSEMANE BRANCH CORPORATION56c9d9fa-09ad-e26a-e063-6394a90a0ed92026-07-17WarningsExact identifier
application number: M005
FUNGAL NAIL TREATMENT kitPSEUDOLARIX AMABILIS BARK 1%GETHSEMANE BRANCH CORPORATION56cb7085-87d8-4273-e063-6394a90ac5df2026-07-17WarningsExact identifier
application number: M005
BeamBalm ANTIFUNGAL FOOT CARETOLNAFTATE 1% ANTIFUNGAL FOOT CAREWenzhou Yuyuan Pharmaceutical Co., Ltd.56b10492-894c-33e1-e063-6394a90a8c0f2026-07-17WarningsExact identifier
application number: M005
Foot Choice-Nail Fungal PenUNDECYLENIC ACIDFoot Choice LLC4b0036a6-8751-4f44-b6b1-5be57fa92cdc2026-07-17WarningsExact identifier
application number: M005
2% MICONAZOLE NITRATE ANTIFUNGAL Cream2% MICONAZOLE NITRATE ANTIFUNGAL CREAMGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd56b54359-db21-b8b4-e063-6394a90a6f8c2026-07-16WarningsExact identifier
application number: M005
DRAVYNOR BALANITIS RELIEF CreamMICONAZOLE NITRATE 2% BALANITIS RELIEF CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.56b76a52-0743-4fe6-e063-6294a90a98a82026-07-16WarningsExact identifier
application number: M005
5% Benzoyl Peroxide FOLLICULITIS Cream5% BENZOYL PEROXIDE FOLLICULITIS CREAMGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd56c558fa-303f-fc52-e063-6394a90a72f02026-07-16WarningsExact identifier
application number: M005
Antifungal Ringworm Treatment CreamMICONAZOLE NITRATEYunqi Cosmetics (Shenzhen) Co., Ltd56a2ceea-c4c0-c30c-e063-6394a90a0e6a2026-07-15WarningsExact identifier
application number: M005
Medi-First Antifungal Cream Miconazole CreamMICONAZOLEUnifirst First Aid Corporation56a51b75-9c23-bcd2-e063-6394a90a9b122026-07-15WarningsExact identifier
application number: M005
Clear Root Labs Tinea TreatmentCLEAR ROOT LABS TINEA TREATMENTAidance Scientic Inc., DBA Aidance Skincare & Topicals56a67bad-c677-d3b7-e063-6394a90ad2052026-07-15WarningsExact identifier
application number: M005
Clear Root Labs Antifungal TreatmentCLEAR ROOT LABS ANTIFUNGAL TREATMENTAidance Scientific, Inc., DBA Aidance Skincare & Topicals5696bf23-230a-5f37-e063-6294a90a74132026-07-15WarningsExact identifier
application number: M005
BeamBalm ANTIFUNGAL NAIL LiquidTOLNAFTATE 1% ANTIFUNGAL NAIL LIQUIDJiangxi Yudexi Pharmaceutical Co., LTD56b17e50-bff1-5eb0-e063-6294a90a3c082026-07-15WarningsExact identifier
application number: M005
terrasil Antifungal Cleansing BarCLOTRIMAZOLEAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions10a4fde0-87e1-4474-bcb5-255b0a7f1ecb2026-07-14WarningsExact identifier
application number: M005
OAKDOLCHE Tea Tree Oil AntifungalTOLNAFTATENanjing Qiaotun Technology Co., Ltd.569dee15-e68d-220e-e063-6294a90af7c52026-07-14WarningsExact identifier
application number: M005
Kimtara Nail Fungus TreatmentKIMTARA NAIL FUNGUS TREATMENTGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd5678e260-10c4-f203-e063-6294a90a62232026-07-13WarningsExact identifier
application number: M005
Aiilo NAIL FUNGUS TREATMENTUNDECYLENIC ACID 25%Guangzhou Huixue Biotechnology Co., Ltd.5689ac31-4d23-0fcc-e063-6394a90ac75b2026-07-13Exact identifier
application number: M005
MIWIFY ANTIFUNGAL NAIL REPAIR PENUNDECYLENIC ACID 25% ANTIFUNGAL NAIL REPAIR PENWenzhou Yuyuan Pharmaceutical Co., Ltd.56519b25-f3c8-bcac-e063-6394a90af8792026-07-11WarningsExact identifier
application number: M005
Joymeey FUNGAL NAIL RENEWALUNDECYLENIC ACID 25% TOLNAFTATE 1% FUNGAL NAIL RENEWALWenzhou Yuyuan Pharmaceutical Co., Ltd.5652a22e-7b43-3c31-e063-6294a90ae4f12026-07-11WarningsExact identifier
application number: M005
iBeaLee Nail Repair PenIBEALEE NAIL REPAIR PENShenzhen Earth Surface Trading Co., Ltd.564dc711-7fe2-7a8d-e063-6294a90aac262026-07-10WarningsExact 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