FDA.reportPublic FDA data

Hand Wash

Product NDC
41163-628
11-digit product format
411630628
Labeler code
41163
Product ID
41163-628_4b08b115-b0f2-5d6e-e063-6294a90ac441
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium chloride
Dosage form
LIQUID
Route
TOPICAL
Labeler
United Natural Foods, Inc. dba UNFI
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-12-20
Substance
BENZALKONIUM CHLORIDE
Active strength
1.3 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Hand Wash
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
2757aafa-9d03-4ad0-9b6b-8cb9ef3cdd90Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41163-628-45Hand Wash946 mL in 1 BOTTLE, PLASTICLIQUID94610
41163-628-96Hand Wash221 mL in 1 BOTTLE, PUMPLIQUID22110

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-628HAND WASH (BENZALKONIUM CHLORIDE) LIQUID [UNITED NATURAL FOODS, INC. DBA UNFI]9Current NDC, Legacy NDC, 2 package rows20250410_2757aafa-9d03-4ad0-9b6b-8cb9ef3cdd90.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
Hand WashBENZALKONIUM CHLORIDEUnited Natural Foods, Inc. dba UNFI2757aafa-9d03-4ad0-9b6b-8cb9ef3cdd902026-02-17Warnings, Adverse reactionsExact identifier
ndc (product): 41163-628

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN2757aafa-9d03-4ad0-9b6b-8cb9ef3cdd9010
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD2757aafa-9d03-4ad0-9b6b-8cb9ef3cdd9010
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY2757aafa-9d03-4ad0-9b6b-8cb9ef3cdd9010
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY2757aafa-9d03-4ad0-9b6b-8cb9ef3cdd9010

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41163-628-4541163062845946 mL in 1 BOTTLE, PLASTIC (41163-628-45) 946 ml2019-12-200000-00-00NoNoCurrent
41163-628-9641163062896221 mL in 1 BOTTLE, PUMP (41163-628-96) 221 ml2019-12-200000-00-00NoNoCurrent