Benzalkonium chloride

Product NDC
62832-628
11-digit product format
628320628
Labeler code
62832
Product ID
62832-628_4b1fe905-40bf-02a5-e063-6294a90a35f9
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium chloride
Dosage form
LIQUID
Route
TOPICAL
Labeler
S. P. Richards Company
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-11-23
Substance
BENZALKONIUM CHLORIDE
Active strength
1.3 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
9223a236-9e9e-42eb-a945-dfe629e4ae3fAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62832-628-96Benzalkonium chloride221 mL in 1 BOTTLE, PLASTICLIQUID2215

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62832-628BENZALKONIUM CHLORIDE LIQUID [S. P. RICHARDS COMPANY]3Current NDC, Legacy NDC, 1 package rows20240920_9223a236-9e9e-42eb-a945-dfe629e4ae3f.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 CHLORIDES. P. Richards Company9223a236-9e9e-42eb-a945-dfe629e4ae3f2026-02-18Warnings, Adverse reactionsExact identifier
ndc (product): 62832-628

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN9223a236-9e9e-42eb-a945-dfe629e4ae3f5
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD9223a236-9e9e-42eb-a945-dfe629e4ae3f5
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY9223a236-9e9e-42eb-a945-dfe629e4ae3f5
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY9223a236-9e9e-42eb-a945-dfe629e4ae3f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62832-628-9662832062896221 mL in 1 BOTTLE, PLASTIC (62832-628-96) 221 ml2021-11-230000-00-00NoNoCurrent