FDA.reportPublic FDA data

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

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 Identifiers#

Field, Values table
FieldValues
Unii06KB629TKV
Rxcui1356533, 1356538

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49406-004-302025-08-18C16284748780-12cef2736-7420-d83d-e063-dadaa90ab31fFungiFoam ANTIFUNGAL
49406-004-752025-08-18C16284748780-12cef2736-7420-d83d-e063-dadaa90ab31fFungiFoam ANTIFUNGAL
49406-004-302025-01-30C16284748780-12cef2736-7420-d83d-e063-dadaa90ab31fFungiFoam ANTIFUNGAL
49406-004-752025-01-30C16284748780-12cef2736-7420-d83d-e063-dadaa90ab31fFungiFoam 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

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