FDA.reportPublic FDA data

Tinactin

Product NDC
11523-0777
11-digit product format
115230777
Labeler code
11523
Product ID
11523-0777_eb02c039-16e2-8698-e053-2a95a90ac5b4
Type
HUMAN OTC DRUG
Nonproprietary name
Tolnaftate
Dosage form
AEROSOL, POWDER
Route
TOPICAL
Labeler
Bayer HealthCare LLC.
Application
part333C
Marketing category
OTC MONOGRAPH FINAL
Marketing start
1993-09-23
Marketing end
0000-00-00
Substance
TOLNAFTATE
Active strength
10 mg/g
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct11523-0777IInactivated by FDA2026-08-11
excluded packagepackage11523-077711523-0777-2IInactivated by FDA2026-08-11

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 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage11523-0777-2d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage11523-0777-2f5e01cc5f278…a2eaf40c39c3…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11523-0777-22025-07-29C16284748780-13b156c62-2563-fb37-e063-e6dba90a4e07Tinactin ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-0777-2Tinactin133 g in 1 CANAEROSOL, POWDER13311

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11523-0777-2GM - Gram11523-077754752fc9-17a4-407b-a3b7-b196ab1b606012012-07-24

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-0777TINACTIN (TOLNAFTATE) AEROSOL, POWDER [BAYER HEALTHCARE LLC.]11Legacy NDC, 1 package rows20241208_00a17e61-0d91-41e0-9cbe-c7c0b3093f3c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
705936Tinactin 1 % Powder SprayPSN00a17e61-0d91-41e0-9cbe-c7c0b3093f3c11
705934tolnaftate 1 % Powder SprayPSN00a17e61-0d91-41e0-9cbe-c7c0b3093f3c11
705936tolnaftate 0.01 MG/MG Powder Spray [Tinactin]SBD00a17e61-0d91-41e0-9cbe-c7c0b3093f3c11
705934tolnaftate 0.01 MG/MG Powder SpraySCD00a17e61-0d91-41e0-9cbe-c7c0b3093f3c11
705936Tinactin 0.01 MG/MG Powder SpraySY00a17e61-0d91-41e0-9cbe-c7c0b3093f3c11
705936Tinactin 1 % Powder SpraySY00a17e61-0d91-41e0-9cbe-c7c0b3093f3c11
705934tolnaftate 1 % Powder SpraySY00a17e61-0d91-41e0-9cbe-c7c0b3093f3c11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11523-0777-211523077702133 g in 1 CAN (11523-0777-2) 133 g1993-09-230000-00-00NoNoCurrent