FDA.reportPublic FDA data

SoftSoap Antibacterial Kitchen Fresh Hands

Product NDC
35000-253
Requested package NDC
35000-253-11
11-digit product format
350000253
Labeler code
35000
Product ID
35000-253_cb0cf44c-950c-499f-acf4-b94ac2fe2b8f
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
2022-10-04
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
SoftSoap Antibacterial Kitchen Fresh Hands
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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1046593Internal RxNorm lookup
1367082Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
65155ce6-5551-491b-a3df-e8ac2cc90ef1Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-253-11SoftSoap Antibacterial Kitchen Fresh Hands332 mL in 1 BOTTLELIQUID3326

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-253SOFTSOAP ANTIBACTERIAL KITCHEN FRESH HANDS (BENZALKONIUM CHLORIDE) LIQUID [COLGATE-PALMOLIVE COMPANY]6Current NDC, Legacy NDC, 1 package rows20241215_65155ce6-5551-491b-a3df-e8ac2cc90ef1.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
SoftSoap Antibacterial Kitchen Fresh HandsBENZALKONIUM CHLORIDEColgate-Palmolive Company65155ce6-5551-491b-a3df-e8ac2cc90ef12024-12-10WarningsExact identifier
ndc (package): 35000-253-11
ndc (product): 35000-253
ndc11 (package): 35000025311

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN65155ce6-5551-491b-a3df-e8ac2cc90ef16
1367082Softsoap Antibacterial 0.13 % Medicated Liquid SoapPSN65155ce6-5551-491b-a3df-e8ac2cc90ef16
1367082benzalkonium chloride 1.3 MG/ML Medicated Liquid Soap [Softsoap Antibacterial]SBD65155ce6-5551-491b-a3df-e8ac2cc90ef16
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD65155ce6-5551-491b-a3df-e8ac2cc90ef16
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY65155ce6-5551-491b-a3df-e8ac2cc90ef16
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY65155ce6-5551-491b-a3df-e8ac2cc90ef16
1367082Softsoap Antibacterial 0.13 % Medicated Liquid SoapSY65155ce6-5551-491b-a3df-e8ac2cc90ef16
1367082Softsoap Antibacterial 1.3 MG/ML Medicated Liquid SoapSY65155ce6-5551-491b-a3df-e8ac2cc90ef16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35000-253-1135000025311332 mL in 1 BOTTLE (35000-253-11) 332 ml2022-10-040000-00-00NoNoCurrent