Kerasal for Athletes Foot Silky Clear

Product NDC
16864-100
11-digit product format
168640100
Labeler code
16864
Product ID
16864-100_d020249e-a8f4-4f76-aafe-871390055517
Type
HUMAN OTC DRUG
Nonproprietary name
TOLNAFTATE
Dosage form
GEL
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 productproduct16864-100DDiscontinued by firm2026-10-05
excluded packagepackage16864-10016864-100-01DDiscontinued 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
16864-100-01Kerasal for Athletes Foot Silky Clear12 g in 1 TUBEGEL124
16864-100-01Kerasal for Athletes Foot Silky Clear1 in 1 CARTONGEL14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16864-100KERASAL FOR ATHLETES FOOT SILKY CLEAR (TOLNAFTATE) GEL [ADVANTICE HEALTH, LLC]3Legacy NDC, 2 package rows20241215_54a7bebf-d7f2-414d-8f1a-8669ddefaa8b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313420tolnaftate 1 % Topical GelPSN54a7bebf-d7f2-414d-8f1a-8669ddefaa8b4
313420tolnaftate 0.01 MG/MG Topical GelSCD54a7bebf-d7f2-414d-8f1a-8669ddefaa8b4
313420tolnaftate 1 % Topical GelSY54a7bebf-d7f2-414d-8f1a-8669ddefaa8b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16864-100-01168640100011 TUBE in 1 CARTON (16864-100-01) > 12 g in 1 TUBE1 tube2022-02-280000-00-00NoNoCurrent