Kerasal Athletes Foot powder

Product NDC
16864-110
Requested package NDC
16864-110-01
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Kerasal Athletes Foot powderTOLNAFTATEAdvantice Health, LLC470d8424-21b8-48e5-8f33-e8baf65c2fb02026-01-13WarningsExact identifier
ndc (package): 16864-110-01
ndc (product): 16864-110
ndc11 (package): 16864011001

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