FDA.reportPublic FDA data

Benzalkonium chloride

Product NDC
41190-278
11-digit product format
411900278
Labeler code
41190
Product ID
41190-278_4aba51f7-3d76-5de4-e063-6294a90a1484
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium chloride 0.13%
Dosage form
SOAP
Route
TOPICAL
Labeler
Wakefern Food Corp.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-07-10
Substance
BENZALKONIUM CHLORIDE
Active strength
1.3 g/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 g/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF5UM2KM3W7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41190-278-03Benzalkonium chloride1470 mL in 1 BOTTLE, PLASTICSOAP147014
41190-278-68Benzalkonium chloride1650 mL in 1 BOTTLE, PUMPSOAP165014
41190-278-96Benzalkonium chloride221 mL in 1 BOTTLE, PUMPSOAP22114

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41190-278BENZALKONIUM CHLORIDE (BENZALKONIUM CHLORIDE 0.13%) SOAP [WAKEFERN FOOD CORP]12Current NDC, Legacy NDC, 3 package rows20241001_d4e823bc-527b-4815-a7e0-47ee8d004e63.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41190-278-03411900278031470 mL in 1 BOTTLE, PLASTIC (41190-278-03) 1470 ml2017-07-100000-00-00NoNoCurrent
41190-278-68411900278681650 mL in 1 BOTTLE, PUMP (41190-278-68) 1650 ml2017-07-100000-00-00NoNoCurrent
41190-278-9641190027896221 mL in 1 BOTTLE, PUMP (41190-278-96) 221 ml2017-07-100000-00-00NoNoCurrent