Benzalkonium Chloride

Product NDC
55319-633
11-digit product format
553190633
Labeler code
55319
Product ID
55319-633_4b93538a-3b43-90f7-e063-6294a90ab898
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
LIQUID
Route
TOPICAL
Labeler
Family Dollar Stores, Inc
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-14
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 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
485b4296-bb2a-ceac-e063-6394a90a5bbaAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-633-03Benzalkonium Chloride1470 mL in 1 BOTTLE, PLASTICLIQUID14702

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
Benzalkonium ChlorideBENZALKONIUM CHLORIDEFamily Dollar Stores, Inc485b4296-bb2a-ceac-e063-6394a90a5bba2026-02-24Warnings, Adverse reactionsExact identifier
ndc (product): 55319-633

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN485b4296-bb2a-ceac-e063-6394a90a5bba2
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD485b4296-bb2a-ceac-e063-6394a90a5bba2
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY485b4296-bb2a-ceac-e063-6394a90a5bba2
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY485b4296-bb2a-ceac-e063-6394a90a5bba2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55319-633-03553190633031470 mL in 1 BOTTLE, PLASTIC (55319-633-03) 1470 ml2026-01-14NoNoCurrent