FDA.reportPublic FDA data

Softsoap Antibacterial with Moisturizers White Tea and Berry LHS

Product NDC
35000-101
Requested package NDC
35000-101-11
11-digit product format
350000101
Labeler code
35000
Product ID
35000-101_c148b42e-d426-47f2-9cfe-c0f83959f3bd
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride Liquid
Dosage form
LIQUID
Route
TOPICAL
Labeler
Colgate-Palmolive Company
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-02-12
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE
Active strength
1 mg/mL
NDC exclude flag
No
Listing certified through
2024-12-31
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 packagepackage35000-10135000-101-11DDiscontinued 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
35000-101-11Softsoap Antibacterial with Moisturizers White Tea and Berry LHS332 mL in 1 BOTTLELIQUID3329

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-101SOFTSOAP ANTIBACTERIAL WITH MOISTURIZERS WHITE TEA AND BERRY LHS (BENZALKONIUM CHLORIDE LIQUID) LIQUID [COLGATE-PALMOLIVE COMPANY]9Legacy NDC, 1 package rows20241212_a00d538e-c409-4dd6-aeb9-092d4ebab196.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSNa00d538e-c409-4dd6-aeb9-092d4ebab1969
1367082Softsoap Antibacterial 0.13 % Medicated Liquid SoapPSNa00d538e-c409-4dd6-aeb9-092d4ebab1969
1367082benzalkonium chloride 1.3 MG/ML Medicated Liquid Soap [Softsoap Antibacterial]SBDa00d538e-c409-4dd6-aeb9-092d4ebab1969
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCDa00d538e-c409-4dd6-aeb9-092d4ebab1969
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSYa00d538e-c409-4dd6-aeb9-092d4ebab1969
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSYa00d538e-c409-4dd6-aeb9-092d4ebab1969
1367082Softsoap Antibacterial 0.13 % Medicated Liquid SoapSYa00d538e-c409-4dd6-aeb9-092d4ebab1969
1367082Softsoap Antibacterial 1.3 MG/ML Medicated Liquid SoapSYa00d538e-c409-4dd6-aeb9-092d4ebab1969

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35000-101-1135000010111332 mL in 1 BOTTLE (35000-101-11) 332 ml2020-02-120000-00-00NoNoCurrent