FDA.reportPublic FDA data

Protex Balance antibacterial hand

Product NDC
35000-675
Requested package NDC
35000-675-12
11-digit product format
350000675
Labeler code
35000
Product ID
35000-675_16fb355d-7e65-466f-956a-ba9ec98c120d
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
2013-08-22
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 packagepackage35000-67535000-675-12DDiscontinued 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
35000-675-12Protex Balance antibacterial hand3780 mL in 1 BOTTLELIQUID37806
35000-675-75Protex Balance antibacterial hand221 mL in 1 BOTTLELIQUID2216

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Benzalkonium chlorideACTIVE INGREDIENTF5UM2KM3W7PROTEX BALANCE ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) LIQUID [COLGATE-PALMOLIVE COMPANY]1
BENZALKONIUMACTIVE MOIETY7N6JUD5X6YPROTEX BALANCE ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) LIQUID [COLGATE-PALMOLIVE COMPANY]1
Cetrimonium chlorideINACTIVE INGREDIENTUC9PE95IBPPROTEX BALANCE ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) LIQUID [COLGATE-PALMOLIVE COMPANY]1
Citric Acid MonohydrateINACTIVE INGREDIENT2968PHW8QPPROTEX BALANCE ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) LIQUID [COLGATE-PALMOLIVE COMPANY]1
Coco MonoethanolamideINACTIVE INGREDIENTC80684146DPROTEX BALANCE ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) LIQUID [COLGATE-PALMOLIVE COMPANY]1
D&C red No. 33INACTIVE INGREDIENT9DBA0SBB0LPROTEX BALANCE ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) LIQUID [COLGATE-PALMOLIVE COMPANY]1
Edetate SodiumINACTIVE INGREDIENTMP1J8420LUPROTEX BALANCE ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) LIQUID [COLGATE-PALMOLIVE COMPANY]1
FD&C yellow No. 5INACTIVE INGREDIENTI753WB2F1MPROTEX BALANCE ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) LIQUID [COLGATE-PALMOLIVE COMPANY]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXPROTEX BALANCE ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) LIQUID [COLGATE-PALMOLIVE COMPANY]1
Lauramidopropylamine oxideINACTIVE INGREDIENTI6KX160QTVPROTEX BALANCE ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) LIQUID [COLGATE-PALMOLIVE COMPANY]1
MethylchloroisothiazolinoneINACTIVE INGREDIENTDEL7T5QRPNPROTEX BALANCE ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) LIQUID [COLGATE-PALMOLIVE COMPANY]1
MethylisothiazolinoneINACTIVE INGREDIENT229D0E1QFAPROTEX BALANCE ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) LIQUID [COLGATE-PALMOLIVE COMPANY]1
PEG-120 methyl glucose dioleateINACTIVE INGREDIENTYM0K64F20VPROTEX BALANCE ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) LIQUID [COLGATE-PALMOLIVE COMPANY]1
Sodium chlorideINACTIVE INGREDIENT451W47IQ8XPROTEX BALANCE ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) LIQUID [COLGATE-PALMOLIVE COMPANY]1
WaterINACTIVE INGREDIENT059QF0KO0RPROTEX BALANCE ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) LIQUID [COLGATE-PALMOLIVE COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-675PROTEX BALANCE ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) LIQUID [COLGATE PALMOLIVE COMPANY]6Legacy NDC, 2 package rows20241030_29a0a75c-a8a1-4d11-87ae-6d2de4fa9518.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN29a0a75c-a8a1-4d11-87ae-6d2de4fa95186
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD29a0a75c-a8a1-4d11-87ae-6d2de4fa95186
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY29a0a75c-a8a1-4d11-87ae-6d2de4fa95186
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY29a0a75c-a8a1-4d11-87ae-6d2de4fa95186

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35000-675-12350000675123780 mL in 1 BOTTLE (35000-675-12) 3780 ml2013-08-220000-00-00NoNoCurrent