Benzalkonium Chloride

Product NDC
59640-346
11-digit product format
596400346
Labeler code
59640
Product ID
59640-346_56426ecd-e3e8-46df-e063-6394a90ab5cd
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
LIQUID
Route
TOPICAL
Labeler
H E B
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-07-10
Substance
BENZALKONIUM CHLORIDE
Active strength
1.3 mg/mL
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 CHLORIDEH E B56426ecd-e3e7-46df-e063-6394a90ab5cd2026-07-10Warnings, Adverse reactionsExact identifier
ndc (product): 59640-346

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
56426ecd-e3e7-46df-e063-6394a90ab5cdAvailable on FDA.report

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleStatus
59640-346-9659640034696221 mL in 1 BOTTLE, PUMP (59640-346-96)221 ml2026-07-100Current