FDA.reportPublic FDA data

WhiskCare 387

Product NDC
65585-531
Requested package NDC
65585-531-06
11-digit product format
655850531
Labeler code
65585
Product ID
65585-531_35bb7d72-6e4f-032f-e063-6394a90a0eba
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
2025-03-31
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 387
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
1233282Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
35bb7d59-111e-fa47-e063-6394a90aaf1eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65585-531-01WhiskCare 38750 mL in 1 BOTTLE, PUMPSOLUTION501
65585-531-03WhiskCare 3878 in 1 BOXSOLUTION81
65585-531-03WhiskCare 3871000 mL in 1 BAGSOLUTION10001
65585-531-04WhiskCare 387500 mL in 1 BOTTLE, PUMPSOLUTION5001
65585-531-04WhiskCare 3876 in 1 BOXSOLUTION61
65585-531-06WhiskCare 3873785 mL in 1 BOTTLE, PLASTICSOLUTION37851
65585-531-08WhiskCare 3874 in 1 BOXSOLUTION41
65585-531-08WhiskCare 3871000 mL in 1 BAGSOLUTION10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65585-531WHISKCARE 387 (BENZALKONIUM CHLORIDE) SOLUTION [WHISK PRODUCTS, INC.]1Current NDC, 8 package rows20250523_35bb7d59-111e-fa47-e063-6394a90aaf1e.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 387BENZALKONIUM CHLORIDEWhisk Products, Inc.35bb7d59-111e-fa47-e063-6394a90aaf1e2025-03-31WarningsExact identifier
ndc (package): 65585-531-06
ndc (product): 65585-531
ndc11 (package): 65585053106

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1233282benzalkonium chloride 0.1 % Medicated Liquid SoapPSN35bb7d59-111e-fa47-e063-6394a90aaf1e1
1233282benzalkonium chloride 1 MG/ML Medicated Liquid SoapSCD35bb7d59-111e-fa47-e063-6394a90aaf1e1
1233282benzalkonium chloride 0.1 % Medicated Liquid SoapSY35bb7d59-111e-fa47-e063-6394a90aaf1e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65585-531-06655850531063785 mL in 1 BOTTLE, PLASTIC (65585-531-06) 3785 ml2025-03-31NoNoCurrent