BENZALKONIUM CHLORIDE

Product NDC
59640-252
Requested package NDC
59640-252-96
11-digit product format
596400252
Labeler code
59640
Product ID
59640-252_56a72ebb-6038-12e4-e063-6294a90a34dc
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
2026-07-15
Substance
BENZALKONIUM CHLORIDE
Active strength
1.3 mg/mL
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
56a72ebb-6037-12e4-e063-6294a90a34dcAvailable on FDA.report

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 CHLORIDEH E B56a72ebb-6037-12e4-e063-6294a90a34dc2026-07-15Warnings, Adverse reactionsExact identifier
ndc (package): 59640-252-96
ndc (product): 59640-252
ndc11 (package): 59640025296

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleStatus
59640-252-9659640025296221 mL in 1 BOTTLE, PUMP (59640-252-96)221 ml2026-07-150Current