FDA.reportPublic FDA data

FOAM-BAC Antibacterial Hand

Product NDC
65585-521
11-digit product format
655850521
Labeler code
65585
Product ID
65585-521_2bc46854-fe62-782b-e063-6294a90a79af
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
SOAP
Route
TOPICAL
Labeler
Whisk Products, Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-04-26
Substance
BENZALKONIUM CHLORIDE
Active strength
1 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FOAM-BAC Antibacterial HandBENZALKONIUM CHLORIDEWhisk Products, Inc.f7ab10b8-1750-436f-a762-6d4d2ca522422025-01-15WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings For external use only. When using this product avoid contact with eyes. In case of eye contact, flush eyes with water. Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Additional Listing Data#

Finished product
Yes
Brand name base
FOAM-BAC Antibacterial Hand
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF5UM2KM3W7
Rxcui1233282

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65585-521-01FOAM-BAC Antibacterial Hand8 in 1 BOXSOAP84
65585-521-01FOAM-BAC Antibacterial Hand1000 mL in 1 BAGSOAP10004
65585-521-02FOAM-BAC Antibacterial Hand6 in 1 BOXSOAP64
65585-521-02FOAM-BAC Antibacterial Hand550 mL in 1 BOTTLE, PUMPSOAP5504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65585-521FOAM-BAC ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) SOAP [WHISK PRODUCTS, INC.]4Current NDC, Legacy NDC, 4 package rows20250117_f7ab10b8-1750-436f-a762-6d4d2ca52242.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1233282benzalkonium chloride 0.1 % Medicated Liquid SoapPSNf7ab10b8-1750-436f-a762-6d4d2ca522424
1233282benzalkonium chloride 1 MG/ML Medicated Liquid SoapSCDf7ab10b8-1750-436f-a762-6d4d2ca522424
1233282benzalkonium chloride 0.1 % Medicated Liquid SoapSYf7ab10b8-1750-436f-a762-6d4d2ca522424

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65585-521-01655850521018 BAG in 1 BOX (65585-521-01) / 1000 mL in 1 BAG8 bag2021-04-260000-00-00NoNoCurrent
65585-521-02655850521026 BOTTLE, PUMP in 1 BOX (65585-521-02) / 550 mL in 1 BOTTLE, PUMP2021-04-260000-00-00NoNoCurrent