Benzalkonium chloride

Product NDC
11344-628
11-digit product format
113440628
Labeler code
11344
Product ID
11344-628_4cea8e9e-19ba-4588-e063-6394a90af763
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium chloride
Dosage form
LIQUID
Route
TOPICAL
Labeler
Nice-Pak Products, LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-12-20
Substance
BENZALKONIUM CHLORIDE
Active strength
1.3 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE1.3 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF5UM2KM3W7
Rxcui1046593

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11344-628-03Benzalkonium chloride1470 mL in 1 BOTTLE, PLASTICLIQUID147018
11344-628-45Benzalkonium chloride946 mL in 1 BOTTLE, PLASTICLIQUID94618
11344-628-57Benzalkonium chloride1180 mL in 1 BOTTLE, PLASTICLIQUID118018
11344-628-96Benzalkonium chloride221 mL in 1 BOTTLE, PLASTICLIQUID22118

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11344-628BENZALKONIUM CHLORIDE LIQUID [CONSUMER PRODUCT PARTNERS, LLC]17Current NDC, 4 package rows20250216_e368e7b8-9695-4dd8-a49b-8c17c24c7f51.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSNe368e7b8-9695-4dd8-a49b-8c17c24c7f5118
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCDe368e7b8-9695-4dd8-a49b-8c17c24c7f5118
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSYe368e7b8-9695-4dd8-a49b-8c17c24c7f5118
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSYe368e7b8-9695-4dd8-a49b-8c17c24c7f5118

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
11344-628-03113440628031470 mL in 1 BOTTLE, PLASTIC1470 mlHistorical
11344-628-4511344062845946 mL in 1 BOTTLE, PLASTIC (11344-628-45) 946 ml2016-12-20NoNoCurrent
11344-628-57113440628571180 mL in 1 BOTTLE, PLASTIC1180 mlHistorical
11344-628-9611344062896221 mL in 1 BOTTLE, PLASTIC (11344-628-96) 221 ml2016-12-20NoNoCurrent