FDA.reportPublic FDA data

Up and Up Soothing Antifungal

Product NDC
23667-816
Requested package NDC
23667-816-01
11-digit product format
236670816
Labeler code
23667
Product ID
23667-816_46c63728-fa49-2132-e054-00144ff8d46c
Type
HUMAN OTC DRUG
Nonproprietary name
TOLNAFTATE
Dosage form
LIQUID
Route
TOPICAL
Labeler
Formulated Solutions, LLC
Application
part333C
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2017-01-23
Marketing end
0000-00-00
Substance
TOLNAFTATE
Active strength
10 mg/g
NDC exclude flag
No
Listing certified through
2020-12-31
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 packagepackage23667-81623667-816-01DDiscontinued 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
23667-816-01Up and Up Soothing Antifungal150 g in 1 CANLIQUID1502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23667-816UP AND UP SOOTHING ANTIFUNGAL (TOLNAFTATE) LIQUID [FORMULATED SOLUTIONS, LLC]2Legacy NDC, 1 package rows20231207_46c63c9a-d471-382e-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313423tolnaftate 1 % Topical SolutionPSN46c63c9a-d471-382e-e054-00144ff8d46c2
313423tolnaftate 10 MG/ML Topical SolutionSCD46c63c9a-d471-382e-e054-00144ff8d46c2
313423tolnaftate 1 % Topical SolutionSY46c63c9a-d471-382e-e054-00144ff8d46c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23667-816-0123667081601150 g in 1 CAN (23667-816-01) 150 g2017-01-230000-00-00NoNoCurrent