Protex Balance antibacterial hand

Product NDC
35000-255
11-digit product format
350000255
Labeler code
35000
Product ID
35000-255_c14dde58-8910-435b-8bb4-2b7a72cee316
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
2022-10-17
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
35000-255-75Protex Balance antibacterial hand221 mL in 1 BOTTLELIQUID2214

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-255PROTEX BALANCE ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) LIQUID [COLGATE-PALMOLIVE COMPANY]3Current NDC, Legacy NDC, 1 package rows20241025_d2514b67-303a-40f4-867b-9f41c0c8cba8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSNd2514b67-303a-40f4-867b-9f41c0c8cba84
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCDd2514b67-303a-40f4-867b-9f41c0c8cba84
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSYd2514b67-303a-40f4-867b-9f41c0c8cba84
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSYd2514b67-303a-40f4-867b-9f41c0c8cba84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35000-255-7535000025575221 mL in 1 BOTTLE (35000-255-75) 221 ml2022-10-170000-00-00NoNoCurrent