FDA.reportPublic FDA data

Tinactin

Product NDC
11523-4162
11-digit product format
115234162
Labeler code
11523
Product ID
11523-4162_4536ec39-08e4-6eed-e063-6294a90a24c4
Type
HUMAN OTC DRUG
Nonproprietary name
Tolnaftate
Dosage form
AEROSOL, POWDER
Route
TOPICAL
Labeler
Bayer HealthCare LLC.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-02-28
Substance
TOLNAFTATE
Active strength
10 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
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
Tinactin
Brand name suffix
Antifungal
Listing expiration
2027-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
705934Internal RxNorm lookup
705936Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5f95be36-6efa-4dfb-9a40-88f4ce1de2b3Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-4162-1TinactinAntifungal133 g in 1 CANAEROSOL, POWDER13310

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TolnaftateACTIVE INGREDIENT06KB629TKVTINACTIN ANTIFUNGAL (TOLNAFTATE) AEROSOL, POWDER [MSD CONSUMER CARE, INC.]1
TolnaftateACTIVE MOIETY06KB629TKVTINACTIN ANTIFUNGAL (TOLNAFTATE) AEROSOL, POWDER [MSD CONSUMER CARE, INC.]1
butylated hydroxytolueneINACTIVE INGREDIENT1P9D0Z171KTINACTIN ANTIFUNGAL (TOLNAFTATE) AEROSOL, POWDER [MSD CONSUMER CARE, INC.]1
isobutaneINACTIVE INGREDIENTBXR49TP611TINACTIN ANTIFUNGAL (TOLNAFTATE) AEROSOL, POWDER [MSD CONSUMER CARE, INC.]1
PPG-12-buteth-16INACTIVE INGREDIENT58CG7042J1TINACTIN ANTIFUNGAL (TOLNAFTATE) AEROSOL, POWDER [MSD CONSUMER CARE, INC.]1
talcINACTIVE INGREDIENT7SEV7J4R1UTINACTIN ANTIFUNGAL (TOLNAFTATE) AEROSOL, POWDER [MSD CONSUMER CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-4162TINACTIN ANTIFUNGAL (TOLNAFTATE) AEROSOL, POWDER [BAYER HEALTHCARE LLC.]9Current NDC, Legacy NDC, 1 package rows20241208_5f95be36-6efa-4dfb-9a40-88f4ce1de2b3.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 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Evercare Antifungal Treatment Super Absorbent PowderMICONAZOLE NITRATEPANEFFORT, LLCf91910f3-b461-43a4-9120-fda69483fffa2023-10-26WarningsExact identifier
application number: M005
Thera plus Antifungal ClotrimazoleCLOTRIMAZOLEFOURSTAR GROUP USA, INC.1265be99-8922-4b76-bd63-19bfb42c38962023-10-26WarningsExact identifier
application number: M005
Thera plus Antifungal TolnaftateTOLNAFTATEFOURSTAR GROUP USA, INC.c628dda8-7a6d-5f3a-e053-2995a90a35f82023-10-26WarningsExact identifier
application number: M005
Povidone IodinePOVIDONE IODINEJianerkang Medical Co., Ltde1789944-3a41-4c86-b173-3a6993ae21412023-10-23WarningsExact identifier
application number: M005
Povidone Iodine ImpregnatedPOVIDONE IODINEJianerkang Medical Co., Ltd14f2a1dd-92c2-49e8-9fa0-a9d88e8c530d2023-10-23WarningsExact identifier
application number: M005
Povidone Iodine ImpregnatedPOVIDONE IODINEJianerkang Medical Co., Ltdb82cea56-b09f-411d-a6cf-c53b3ce0e3b62023-10-23WarningsExact identifier
application number: M005
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
705936Tinactin 1 % Powder SprayPSN5f95be36-6efa-4dfb-9a40-88f4ce1de2b310
705934tolnaftate 1 % Powder SprayPSN5f95be36-6efa-4dfb-9a40-88f4ce1de2b310
705936tolnaftate 0.01 MG/MG Powder Spray [Tinactin]SBD5f95be36-6efa-4dfb-9a40-88f4ce1de2b310
705934tolnaftate 0.01 MG/MG Powder SpraySCD5f95be36-6efa-4dfb-9a40-88f4ce1de2b310
705936Tinactin 0.01 MG/MG Powder SpraySY5f95be36-6efa-4dfb-9a40-88f4ce1de2b310
705936Tinactin 1 % Powder SpraySY5f95be36-6efa-4dfb-9a40-88f4ce1de2b310
705934tolnaftate 1 % Powder SpraySY5f95be36-6efa-4dfb-9a40-88f4ce1de2b310

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11523-4162-111523416201133 g in 1 CAN (11523-4162-1) 133 g2014-02-280000-00-00NoNoCurrent