FDA.reportPublic FDA data

Tolnafate

Product NDC
79481-0592
11-digit product format
794810592
Labeler code
79481
Product ID
79481-0592_dd2fa6a2-2ba6-4333-e053-2a95a90a9790
Type
HUMAN OTC DRUG
Nonproprietary name
Tolnaftate Powder Spray
Dosage form
AEROSOL, SPRAY
Route
TOPICAL
Labeler
Meijer Distribution Inc.
Application
part333C
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-03-11
Marketing end
0000-00-00
Substance
TOLNAFTATE
Active strength
1 g/130g
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 productproduct79481-0592DDiscontinued by firm2026-10-12
excluded packagepackage79481-059279481-0592-1DDiscontinued by firm2026-10-12

Reported adverse events (FAERS/openFDA)#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79481-0592TOLNAFATE (TOLNAFTATE POWDER SPRAY) AEROSOL, SPRAY [MEIJER DISTRIBUTION INC.]5Legacy NDC20241016_db03a4b1-72b1-2fce-e053-2a95a90a0faf.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79481-0592-179481059201130 g in 1 CAN (79481-0592-1) 130 g2022-03-110000-00-00NoNoCurrent