FDA.reportPublic FDA data

Foaming Hand

Product NDC
11344-224
Requested package NDC
11344-224-08
11-digit product format
113440224
Labeler code
11344
Product ID
11344-224_4cd559bd-73d9-fdfb-e063-6294a90a0afe
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
LOTION
Route
TOPICAL
Labeler
Nice-Pak Products, LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-02-08
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
Foaming Hand
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
1020365Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2002c182-b4a6-4baa-8497-74570713b8bbAvailable 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
11344-224-04Foaming Hand750 mL in 1 BOTTLE, PLASTICLOTION75018
11344-224-08Foaming Hand3785 mL in 1 BOTTLE, PLASTICLOTION378518
11344-224-20Foaming Hand44 mL in 1 BOTTLE, DISPENSINGLOTION4418
11344-224-44Foaming Hand532 mL in 1 BOTTLE, PLASTICLOTION53218
11344-224-45Foaming Hand1150 mL in 1 BOTTLE, PLASTICLOTION115018
11344-224-86Foaming Hand1000 mL in 1 BOTTLE, DISPENSINGLOTION100018
11344-224-96Foaming Hand222 mL in 1 BOTTLE, PUMPLOTION22218

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11344-224FOAMING HAND (BENZALKONIUM CHLORIDE) LOTION [CONSUMER PRODUCT PARTNERS, LLC]17Current NDC, Legacy NDC, 7 package rows20250416_2002c182-b4a6-4baa-8497-74570713b8bb.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
Foaming HandBENZALKONIUM CHLORIDENice-Pak Products, LLC2002c182-b4a6-4baa-8497-74570713b8bb2026-03-12Warnings, Adverse reactionsExact identifier
ndc (package): 11344-224-08
ndc (product): 11344-224
ndc11 (package): 11344022408

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020365benzalkonium chloride 0.13 % Topical FoamPSN2002c182-b4a6-4baa-8497-74570713b8bb18
1020365benzalkonium chloride 1.3 MG/ML Topical FoamSCD2002c182-b4a6-4baa-8497-74570713b8bb18
1020365benzalkonium chloride 0.13 % Topical FoamSY2002c182-b4a6-4baa-8497-74570713b8bb18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11344-224-08113440224083785 mL in 1 BOTTLE, PLASTIC (11344-224-08) 3785 ml2018-02-080000-00-00NoNoCurrent