FDA.reportPublic FDA data

Tolnaftate

Product NDC
68016-609
Requested package NDC
68016-609-00
11-digit product format
680160609
Labeler code
68016
Product ID
68016-609_c78ddff9-cfbd-d920-e053-2a95a90a8ba6
Type
HUMAN OTC DRUG
Nonproprietary name
Antifungal Spray Liquid
Dosage form
AEROSOL, SPRAY
Route
TOPICAL
Labeler
Chain Drug Consortium, LLC
Application
part333C
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2003-05-23
Marketing end
0000-00-00
Substance
TOLNAFTATE
Active strength
0 g/150g
NDC exclude flag
No
Listing certified through
2022-12-31
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 packagepackage68016-60968016-609-00DDiscontinued by firm2026-09-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOLNAFTATEACTIVE INGREDIENT06KB629TKVTOLNAFTATE (ANTIFUNGAL SPRAY LIQUID) AEROSOL, SPRAY [CHAIN DRUG CONSORTIUM, LLC]2
TOLNAFTATEACTIVE MOIETY06KB629TKVTOLNAFTATE (ANTIFUNGAL SPRAY LIQUID) AEROSOL, SPRAY [CHAIN DRUG CONSORTIUM, LLC]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MTOLNAFTATE (ANTIFUNGAL SPRAY LIQUID) AEROSOL, SPRAY [CHAIN DRUG CONSORTIUM, LLC]2
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KTOLNAFTATE (ANTIFUNGAL SPRAY LIQUID) AEROSOL, SPRAY [CHAIN DRUG CONSORTIUM, LLC]2
ISOBUTANEINACTIVE INGREDIENTBXR49TP611TOLNAFTATE (ANTIFUNGAL SPRAY LIQUID) AEROSOL, SPRAY [CHAIN DRUG CONSORTIUM, LLC]2
PPG-12-BUTETH-16INACTIVE INGREDIENT58CG7042J1TOLNAFTATE (ANTIFUNGAL SPRAY LIQUID) AEROSOL, SPRAY [CHAIN DRUG CONSORTIUM, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-609TOLNAFTATE (ANTIFUNGAL SPRAY LIQUID) AEROSOL, SPRAY [CHAIN DRUG CONSORTIUM, LLC]8Legacy NDC20241213_4bc5b883-23e6-41a0-a2f6-3eb6100dd48d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-609-0068016060900150 g in 1 CAN (68016-609-00) 150 g2003-05-230000-00-00NoNoCurrent