FDA.reportPublic FDA data

SoftSoap Antibacterial Kitchen Fresh Hands

Product NDC
35000-088
Requested package NDC
35000-088-55
11-digit product format
350000088
Labeler code
35000
Product ID
35000-088_1f34bf59-8533-4dbc-9f26-a6b901ec8c97
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium chloride
Dosage form
LIQUID
Route
TOPICAL
Labeler
Colgate-Palmolive Company
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2016-08-19
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 packagepackage35000-08835000-088-55DDiscontinued 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
35000-088-11SoftSoap Antibacterial Kitchen Fresh Hands332 mL in 1 BOTTLELIQUID3324
35000-088-55SoftSoap Antibacterial Kitchen Fresh Hands1478 mL in 1 BOTTLELIQUID14784
35000-088-91SoftSoap Antibacterial Kitchen Fresh Hands1656 mL in 1 BOTTLELIQUID16564

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-088SOFTSOAP ANTIBACTERIAL KITCHEN FRESH HANDS (BENZALKONIUM CHLORIDE) LIQUID [COLGATE PALMOLIVE COMPANY]4Legacy NDC, 3 package rows20241030_8acf71fd-079f-4434-82bd-f4bf3279b559.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN8acf71fd-079f-4434-82bd-f4bf3279b5594
1367082Softsoap Antibacterial 0.13 % Medicated Liquid SoapPSN8acf71fd-079f-4434-82bd-f4bf3279b5594
1367082benzalkonium chloride 1.3 MG/ML Medicated Liquid Soap [Softsoap Antibacterial]SBD8acf71fd-079f-4434-82bd-f4bf3279b5594
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD8acf71fd-079f-4434-82bd-f4bf3279b5594
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY8acf71fd-079f-4434-82bd-f4bf3279b5594
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY8acf71fd-079f-4434-82bd-f4bf3279b5594
1367082Softsoap Antibacterial 0.13 % Medicated Liquid SoapSY8acf71fd-079f-4434-82bd-f4bf3279b5594
1367082Softsoap Antibacterial 1.3 MG/ML Medicated Liquid SoapSY8acf71fd-079f-4434-82bd-f4bf3279b5594

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35000-088-55350000088551478 mL in 1 BOTTLE (35000-088-55) 1478 ml2019-01-050000-00-00NoNoCurrent