Benzalkonium chloride

Product NDC
68016-866
11-digit product format
680160866
Labeler code
68016
Product ID
68016-866_4a1a0553-c314-c127-e063-6394a90aacb5
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium chloride
Dosage form
LIQUID
Route
TOPICAL
Labeler
Pharmacy Value Alliance, LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-06-29
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
68016-866-45Benzalkonium chloride946 mL in 1 BOTTLE, PLASTICLIQUID9464
68016-866-96Benzalkonium chloride221 mL in 1 BOTTLE, PLASTICLIQUID2214

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-866BENZALKONIUM CHLORIDE LIQUID [PHARMACY VALUE ALLIANCE, LLC]3Current NDC, 2 package rows20250515_5f9521f2-53f2-4d7e-9116-36e94e2d0695.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN5f9521f2-53f2-4d7e-9116-36e94e2d06954
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD5f9521f2-53f2-4d7e-9116-36e94e2d06954
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY5f9521f2-53f2-4d7e-9116-36e94e2d06954
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY5f9521f2-53f2-4d7e-9116-36e94e2d06954

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68016-866-4568016086645946 mL in 1 BOTTLE, PLASTIC (68016-866-45) 946 ml2023-06-29NoNoHistorical
68016-866-9668016086696221 mL in 1 BOTTLE, PLASTIC (68016-866-96) 221 ml2023-06-29NoNoHistorical