Benzalkonium chloride

Product NDC
55301-278
11-digit product format
553010278
Labeler code
55301
Product ID
55301-278_4aa2e6ff-2b15-cdda-e063-6294a90ac83c
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium chloride 0.13%
Dosage form
SOAP
Route
TOPICAL
Labeler
Your Military Exchanges
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-05-19
Substance
BENZALKONIUM CHLORIDE
Active strength
1.3 g/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 g/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 SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8dd3bb4d-9cb5-4994-9c77-fa5b8e69ec2bAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55301-278-96Benzalkonium chloride221 mL in 1 BOTTLE, PUMPSOAP22110

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55301-278BENZALKONIUM CHLORIDE (BENZALKONIUM CHLORIDE 0.13%) SOAP [YOUR MILITARY EXCHANGES]8Current NDC, Legacy NDC, 1 package rows20240918_8dd3bb4d-9cb5-4994-9c77-fa5b8e69ec2b.zip

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 CHLORIDE 0.13%Your Military Exchanges8dd3bb4d-9cb5-4994-9c77-fa5b8e69ec2b2026-02-12Warnings, Adverse reactionsExact identifier
ndc (product): 55301-278

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55301-278-9655301027896221 mL in 1 BOTTLE, PUMP (55301-278-96) 221 ml2015-05-190000-00-00NoNoCurrent