Kerasal Athletes Foot powder

Product NDC
16864-110
11-digit product format
168640110
Labeler code
16864
Product ID
16864-110_9eae4eb3-2ceb-4940-aa0e-e77222886d1b
Type
HUMAN OTC DRUG
Nonproprietary name
Tolnaftate
Dosage form
SPRAY
Route
TOPICAL
Labeler
Advantice Health, LLC
Application
part333C
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-02-28
Marketing end
0000-00-00
Substance
TOLNAFTATE
Active strength
1 g/100g
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 productproduct16864-110DDiscontinued by firm2026-10-05
excluded packagepackage16864-11016864-110-01DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16864-110-01Kerasal Athletes Foot powder57 g in 1 CANSPRAY574

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16864-110KERASAL ATHLETES FOOT POWDER (TOLNAFTATE) SPRAY [ADVANTICE HEALTH, LLC]3Legacy NDC, 1 package rows20241215_470d8424-21b8-48e5-8f33-e8baf65c2fb0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
705934tolnaftate 1 % Powder SprayPSN470d8424-21b8-48e5-8f33-e8baf65c2fb04
705934tolnaftate 0.01 MG/MG Powder SpraySCD470d8424-21b8-48e5-8f33-e8baf65c2fb04
705934tolnaftate 1 % Powder SpraySY470d8424-21b8-48e5-8f33-e8baf65c2fb04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16864-110-011686401100157 g in 1 CAN (16864-110-01) 57 g2022-02-280000-00-00NoNoCurrent