FDA.reportPublic FDA data

Moisturizing Antibacterial

Product NDC
63941-279
Requested package NDC
63941-279-03
11-digit product format
639410279
Labeler code
63941
Product ID
63941-279_3a14f68f-a6e1-4144-b362-838cba0929af
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium chloride 0.13%
Dosage form
SOAP
Route
TOPICAL
Labeler
Valu Merchandisers, CO
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2016-02-02
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE
Active strength
1 g/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 packagepackage63941-27963941-279-03DDiscontinued by firm2026-11-12

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
63941-279-03Moisturizing Antibacterial1478 mL in 1 BOTTLE, PLASTICSOAP147818
63941-279-81Moisturizing Antibacterial332 mL in 1 BOTTLE, PLASTICSOAP33218
63941-279-96Moisturizing Antibacterial221 mL in 1 BOTTLE, PUMPSOAP22118

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63941-279MOISTURIZING ANTIBACTERIAL (BENZALKONIUM CHLORIDE 0.13%) SOAP [VALU MERCHANDISERS, CO]15Legacy NDC, 3 package rows20240906_fb9071d7-e44a-47fc-b76d-faf6220a57bf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSNfb9071d7-e44a-47fc-b76d-faf6220a57bf18
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCDfb9071d7-e44a-47fc-b76d-faf6220a57bf18
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSYfb9071d7-e44a-47fc-b76d-faf6220a57bf18
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSYfb9071d7-e44a-47fc-b76d-faf6220a57bf18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63941-279-03639410279031478 mL in 1 BOTTLE, PLASTIC (63941-279-03) 1478 ml2016-02-020000-00-00NoNoCurrent