Antifungal Cream Tolnaftate 1%

Product NDC
79481-0015
Requested package NDC
79481-0015-5
11-digit product format
794810015
Labeler code
79481
Product ID
79481-0015_f2026976-ae4a-a6ea-e053-2a95a90ae6ac
Type
HUMAN OTC DRUG
Nonproprietary name
Tolnaftate
Dosage form
CREAM
Route
TOPICAL
Labeler
Meijer
Application
part333C
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-05-12
Marketing end
0000-00-00
Substance
TOLNAFTATE
Active strength
1 g/100g
NDC exclude flag
No
Listing certified through
2024-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage79481-001579481-0015-5IInactivated by FDA2026-10-05

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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79481-0015-52025-01-30C16284748780-12cef2736-6214-d83d-e063-dadaa90ab31fMeijer Antifungal Cream Tolnaftate 1%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79481-0015-5Antifungal Cream Tolnaftate 1%1 in 1 BOXCREAM12
79481-0015-5Antifungal Cream Tolnaftate 1%14 g in 1 TUBECREAM142

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79481-0015ANTIFUNGAL CREAM TOLNAFTATE 1% (TOLNAFTATE) CREAM [MEIJER]2Legacy NDC, 2 package rows20230112_c1211964-e814-4737-e053-2995a90a8d3e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
103951tolnaftate 1 % Topical CreamPSNc1211964-e814-4737-e053-2995a90a8d3e2
103951tolnaftate 10 MG/ML Topical CreamSCDc1211964-e814-4737-e053-2995a90a8d3e2
103951tolnaftate 1 % Topical CreamSYc1211964-e814-4737-e053-2995a90a8d3e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79481-0015-5794810015051 TUBE in 1 BOX (79481-0015-5) > 14 g in 1 TUBE1 tube2021-05-120000-00-00NoNoCurrent