Protex Balance antibacterial hand

Product NDC
35000-675
11-digit product format
350000675
Labeler code
35000
Product ID
35000-675_3135e724-f2fb-4509-af82-51ad83107461
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium chloride
Dosage form
LIQUID
Route
TOPICAL
Labeler
COLGATE PALMOLIVE COMPANY
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-08-22
Substance
BENZALKONIUM CHLORIDE
Active strength
1.33 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Protex Balance antibacterial hand
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE1.33 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF5UM2KM3W7
Rxcui1046593

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]6Current NDC, Legacy 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
35000-675-7535000067575221 mL in 1 BOTTLE (35000-675-75) 221 ml2013-08-220000-00-00NoNoCurrent