Antibacterial

Product NDC
65321-031
11-digit product format
653210031
Labeler code
65321
Product ID
65321-031_bcf62e89-3ee6-49c1-9223-3d37ec35e5ff
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
SOAP
Route
TOPICAL
Labeler
Rubbermaid Commercial Products LLC
Application
M003
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE13 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF5UM2KM3W7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65321-031-01Antibacterial800 mL in 1 BOTTLE, PUMPSOAP8005
65321-031-02Antibacterial1600 mL in 1 BOTTLE, PUMPSOAP16005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65321-031ANTIBACTERIAL (BENZALKONIUM CHLORIDE) SOAP [RUBBERMAID COMMERCIAL PRODUCTS LLC]5Current NDC, Legacy NDC, 2 package rows20241013_6023285c-6b02-410e-9492-df0543279f25.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN6023285c-6b02-410e-9492-df0543279f255
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD6023285c-6b02-410e-9492-df0543279f255
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY6023285c-6b02-410e-9492-df0543279f255
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY6023285c-6b02-410e-9492-df0543279f255

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65321-031-0165321003101800 mL in 1 BOTTLE, PUMP (65321-031-01) 800 ml2017-07-240000-00-00NoNoCurrent
65321-031-02653210031021600 mL in 1 BOTTLE, PUMP (65321-031-02) 1600 ml2017-07-240000-00-00NoNoCurrent