FDA.reportPublic FDA data

Derman Antifungal Powder Tolnaftate

Product NDC
81929-001
11-digit product format
819290001
Labeler code
81929
Product ID
81929-001_3bc67eff-f2f0-508f-e063-6294a90af174
Type
HUMAN OTC DRUG
Nonproprietary name
TOLNAFTATE
Dosage form
AEROSOL, POWDER
Route
TOPICAL
Labeler
Taisho Pharmaceutical California Inc.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-05-01
Marketing end
2028-11-30
Substance
TOLNAFTATE
Active strength
10 mg/g
NDC exclude flag
No
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
Derman Antifungal Powder Tolnaftate

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
705934Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3a854765-740c-4719-8abf-4b3f932cdee0Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81929-001-01Derman Antifungal Powder Tolnaftate130 g in 1 CANAEROSOL, POWDER1304
81929-001-01Derman Antifungal Powder Tolnaftate1 in 1 BOXAEROSOL, POWDER14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81929-001DERMAN ANTIFUNGAL POWDER TOLNAFTATE (TOLNAFTATE) AEROSOL, POWDER [TAISHO PHARMACEUTICAL CALIFORNIA INC.]3Current NDC, Legacy NDC, 2 package rows20231111_3a854765-740c-4719-8abf-4b3f932cdee0.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 49 of 49 · 967 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Povidone Iodine ScrubPOVIDONE-IODINEJianerkang Medical Co., Ltd78131b57-1ffc-4eb8-821e-f7bb73300fe92023-10-23WarningsExact identifier
application number: M005
Povidone IodinePOVIDONE IODINEJianerkang Medical Co., Ltdeb30e5de-9074-4760-8e92-e1d1c127227d2023-10-23WarningsExact identifier
application number: M005
Povidone IodinePOVIDONE IODINEJianerkang Medical Co., Ltd0bd3de76-b726-41f1-87bc-14ab8a1eca8e2023-10-23WarningsExact identifier
application number: M005
Povidone Iodine Prep PadPOVIDONE-IODINEJianerkang Medical Co., Ltdbe85ec5b-eb49-4f1a-a87d-5c9705a20f232023-10-22WarningsExact identifier
application number: M005
EVERLIT CARE Hand SanitizerETHYL ALCOHOLNantong Health & Beyond Hygienic Products Inc.579c1ab5-50b4-4b5a-a189-c1e2827d0c3a2023-10-14WarningsExact identifier
application number: M005
Micomitin AntifungalCLOTRIMAZOLEPureTek Corporationdd05f5f9-2412-1295-e053-2995a90acb962022-02-14WarningsExact identifier
application number: M005
MicatinMICONAZOLE NITRATEWellSpring Pharmaceutical Corporation96c56ba1-c3a8-48ce-ab58-550959485e3c2016-04-07WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
705934tolnaftate 1 % Powder SprayPSN3a854765-740c-4719-8abf-4b3f932cdee04
705934tolnaftate 0.01 MG/MG Powder SpraySCD3a854765-740c-4719-8abf-4b3f932cdee04
705934tolnaftate 1 % Powder SpraySY3a854765-740c-4719-8abf-4b3f932cdee04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81929-001-01819290001011 CAN in 1 BOX (81929-001-01) / 130 g in 1 CAN1 can2022-05-012028-11-30NoNoCurrent