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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

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

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