FDA.reportPublic FDA data

Hand Wash

Product NDC
53942-466
Requested package NDC
53942-466-96
11-digit product format
539420466
Labeler code
53942
Product ID
53942-466_d3f196c7-a61a-4fd5-86fe-7b282ab51897
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium chloride
Dosage form
LIQUID
Route
TOPICAL
Labeler
Demoulas Super Markets, Inc
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-06-01
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE
Active strength
1 mg/mL
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 packagepackage53942-46653942-466-96DDiscontinued by firm2026-11-13

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
53942-466-45Hand Wash946 mL in 1 BOTTLE, PLASTICLIQUID94614
53942-466-96Hand Wash221 mL in 1 BOTTLE, PUMPLIQUID22114

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53942-466HAND WASH (BENZALKONIUM CHLORIDE) LIQUID [DEMOULAS SUPER MARKETS, INC]11Legacy NDC, 2 package rows20240820_3fe61130-9ec2-4e71-b147-320a81c4344c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN3fe61130-9ec2-4e71-b147-320a81c4344c14
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD3fe61130-9ec2-4e71-b147-320a81c4344c14
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY3fe61130-9ec2-4e71-b147-320a81c4344c14
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY3fe61130-9ec2-4e71-b147-320a81c4344c14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53942-466-9653942046696221 mL in 1 BOTTLE, PUMP (53942-466-96) 221 ml2014-06-010000-00-00NoNoCurrent