FDA.reportPublic FDA data

WhiskCare 377

Product NDC
65585-528
11-digit product format
655850528
Labeler code
65585
Product ID
65585-528_23e6f539-a31a-397a-e063-6394a90ae793
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Whisk Products, Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-08-28
Substance
BENZALKONIUM CHLORIDE
Active strength
1 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
WhiskCare 377
Brand name suffix
Free
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE1 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
1038799Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
20c31cf2-7d01-ce84-e063-6294a90a1c3dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65585-528-01WhiskCare 377Free1000 mL in 1 BAGSOLUTION10002
65585-528-01WhiskCare 377Free4 in 1 BOXSOLUTION42
65585-528-02WhiskCare 377Free1000 mL in 1 BAGSOLUTION10002
65585-528-02WhiskCare 377Free8 in 1 BOXSOLUTION82
65585-528-03WhiskCare 377Free3785 mL in 1 BOTTLE, PLASTICSOLUTION37852

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65585-528WHISKCARE 377 FREE (BENZALKONIUM CHLORIDE) SOLUTION [WHISK PRODUCTS, INC.]2Current NDC, 5 package rows20241009_20c31cf2-7d01-ce84-e063-6294a90a1c3d.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
WhiskCare 377 FreeBENZALKONIUM CHLORIDEWhisk Products, Inc.20c31cf2-7d01-ce84-e063-6294a90a1c3d2024-10-07WarningsExact identifier
ndc (product): 65585-528

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038799benzalkonium chloride 0.1 % Topical FoamPSN20c31cf2-7d01-ce84-e063-6294a90a1c3d2
1038799benzalkonium chloride 1 MG/ML Topical FoamSCD20c31cf2-7d01-ce84-e063-6294a90a1c3d2
1038799benzalkonium chloride 0.1 % Topical FoamSY20c31cf2-7d01-ce84-e063-6294a90a1c3d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65585-528-01655850528014 BAG in 1 BOX (65585-528-01) / 1000 mL in 1 BAG4 bag2024-08-28NoNoCurrent
65585-528-02655850528028 BAG in 1 BOX (65585-528-02) / 1000 mL in 1 BAG8 bag2024-08-28NoNoCurrent
65585-528-03655850528033785 mL in 1 BOTTLE, PLASTIC (65585-528-03) 3785 ml2024-08-28NoNoCurrent