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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tinactin
Brand name suffix
Antifungal
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii06KB629TKV
Rxcui705934, 705936

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

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