FDA.reportPublic FDA data

Softsoap Antibacterial Kitchen Fresh Hands

Product NDC
35000-098
Requested package NDC
35000-098-11
11-digit product format
350000098
Labeler code
35000
Product ID
35000-098_dd76f046-c6e8-4437-9315-501fafab8393
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
2020-02-14
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 packagepackage35000-09835000-098-11DDiscontinued 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
35000-098-11Softsoap Antibacterial Kitchen Fresh Hands332 mL in 1 BOTTLELIQUID3329

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-098SOFTSOAP ANTIBACTERIAL KITCHEN FRESH HANDS (BENZALKONIUM CHLORIDE LIQUID) LIQUID [COLGATE-PALMOLIVE COMPANY]9Legacy NDC, 1 package rows20241212_e3c74581-de9c-46bf-899b-03384c8be33c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSNe3c74581-de9c-46bf-899b-03384c8be33c9
1367082Softsoap Antibacterial 0.13 % Medicated Liquid SoapPSNe3c74581-de9c-46bf-899b-03384c8be33c9
1367082benzalkonium chloride 1.3 MG/ML Medicated Liquid Soap [Softsoap Antibacterial]SBDe3c74581-de9c-46bf-899b-03384c8be33c9
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCDe3c74581-de9c-46bf-899b-03384c8be33c9
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSYe3c74581-de9c-46bf-899b-03384c8be33c9
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSYe3c74581-de9c-46bf-899b-03384c8be33c9
1367082Softsoap Antibacterial 0.13 % Medicated Liquid SoapSYe3c74581-de9c-46bf-899b-03384c8be33c9
1367082Softsoap Antibacterial 1.3 MG/ML Medicated Liquid SoapSYe3c74581-de9c-46bf-899b-03384c8be33c9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35000-098-1135000009811332 mL in 1 BOTTLE (35000-098-11) 332 ml2020-02-140000-00-00NoNoCurrent