FDA.reportPublic FDA data

Antibacterial Hand Wash

Product NDC
65321-032
11-digit product format
653210032
Labeler code
65321
Product ID
65321-032_e9e41018-ec83-4f99-ad56-c5c28c5c4140
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
SOAP
Route
TOPICAL
Labeler
Rubbermaid Commercial Products LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-07-24
Substance
BENZALKONIUM CHLORIDE
Active strength
13 mg/10mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Antibacterial Hand Wash
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE13 mg/10mL

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
b71ba5ce-096e-4d56-831f-a2d208157ab7Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65321-032-01Antibacterial Hand Wash400 mL in 1 BAGSOAP4008
65321-032-02Antibacterial Hand Wash800 mL in 1 BAGSOAP8008
65321-032-03Antibacterial Hand Wash1100 mL in 1 BAGSOAP11008
65321-032-04Antibacterial Hand Wash1300 mL in 1 BAGSOAP13008
65321-032-05Antibacterial Hand Wash500 mL in 1 BAGSOAP5008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65321-032ANTIBACTERIAL HAND WASH (BENZALKONIUM CHLORIDE) SOAP [RUBBERMAID COMMERCIAL PRODUCTS LLC]8Current NDC, Legacy NDC, 5 package rows20231219_b71ba5ce-096e-4d56-831f-a2d208157ab7.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
Antibacterial Hand WashBENZALKONIUM CHLORIDERubbermaid Commercial Products LLCb71ba5ce-096e-4d56-831f-a2d208157ab72026-06-08WarningsExact identifier
ndc (product): 65321-032

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSNb71ba5ce-096e-4d56-831f-a2d208157ab78
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCDb71ba5ce-096e-4d56-831f-a2d208157ab78
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSYb71ba5ce-096e-4d56-831f-a2d208157ab78
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSYb71ba5ce-096e-4d56-831f-a2d208157ab78

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65321-032-0165321003201400 mL in 1 BAG (65321-032-01) 400 ml2017-07-240000-00-00NoNoCurrent
65321-032-0265321003202800 mL in 1 BAG (65321-032-02) 800 ml2017-07-240000-00-00NoNoCurrent
65321-032-03653210032031100 mL in 1 BAG (65321-032-03) 1100 ml2017-07-240000-00-00NoNoCurrent
65321-032-04653210032041300 mL in 1 BAG (65321-032-04) 1300 ml2017-07-240000-00-00NoNoCurrent
65321-032-0565321003205500 mL in 1 BAG (65321-032-05) 500 ml2021-01-190000-00-00NoNoCurrent