FDA.reportPublic FDA data

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F5UM2KM3W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1046593Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d2514b67-303a-40f4-867b-9f41c0c8cba8Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Protex Balance antibacterial handBENZALKONIUM CHLORIDEColgate-Palmolive Companyd2514b67-303a-40f4-867b-9f41c0c8cba82025-11-24WarningsExact identifier
ndc (product): 35000-255

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