FDA.reportPublic FDA data

WhiskCare 377

Product NDC
65585-529
11-digit product format
655850529
Labeler code
65585
Product ID
65585-529_2204be42-078c-37e9-e063-6294a90a20ab
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
2024-08-01
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
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
2204c224-e12a-81c6-e063-6294a90a9fa4Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65585-529-01WhiskCare 37750 mL in 1 BOTTLE, PUMPSOLUTION501
65585-529-02WhiskCare 37750 mL in 1 BOTTLE, PUMPSOLUTION501
65585-529-02WhiskCare 37724 in 1 BOXSOLUTION241
65585-529-03WhiskCare 377208198 mL in 1 DRUMSOLUTION2081981
65585-529-04WhiskCare 3774 in 1 BOXSOLUTION41
65585-529-04WhiskCare 3771000 mL in 1 BAGSOLUTION10001
65585-529-05WhiskCare 3778 in 1 BOXSOLUTION81
65585-529-05WhiskCare 3771000 mL in 1 BAGSOLUTION10001
65585-529-06WhiskCare 377550 mL in 1 BOTTLE, PUMPSOLUTION5501
65585-529-06WhiskCare 3776 in 1 BOXSOLUTION61
65585-529-07WhiskCare 3773785 mL in 1 BOTTLE, PLASTICSOLUTION37851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65585-529WHISKCARE 377 (BENZALKONIUM CHLORIDE) SOLUTION [WHISK PRODUCTS, INC.]1Current NDC, 11 package rows20240915_2204c224-e12a-81c6-e063-6294a90a9fa4.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 377BENZALKONIUM CHLORIDEWhisk Products, Inc.2204c224-e12a-81c6-e063-6294a90a9fa42024-08-01WarningsExact identifier
ndc (product): 65585-529

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038799benzalkonium chloride 0.1 % Topical FoamPSN2204c224-e12a-81c6-e063-6294a90a9fa41
1038799benzalkonium chloride 1 MG/ML Topical FoamSCD2204c224-e12a-81c6-e063-6294a90a9fa41
1038799benzalkonium chloride 0.1 % Topical FoamSY2204c224-e12a-81c6-e063-6294a90a9fa41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65585-529-016558505290150 mL in 1 BOTTLE, PUMP (65585-529-01) 50 ml2024-08-01YesNoCurrent
65585-529-026558505290224 BOTTLE, PUMP in 1 BOX (65585-529-02) / 50 mL in 1 BOTTLE, PUMP2024-08-01NoNoCurrent
65585-529-0365585052903208198 mL in 1 DRUM (65585-529-03) 208198 ml2024-08-01NoNoCurrent
65585-529-04655850529044 BAG in 1 BOX (65585-529-04) / 1000 mL in 1 BAG4 bag2024-08-01NoNoCurrent
65585-529-05655850529058 BAG in 1 BOX (65585-529-05) / 1000 mL in 1 BAG8 bag2024-08-01NoNoCurrent
65585-529-06655850529066 BOTTLE, PUMP in 1 BOX (65585-529-06) / 550 mL in 1 BOTTLE, PUMP2024-08-01NoNoCurrent
65585-529-07655850529073785 mL in 1 BOTTLE, PLASTIC (65585-529-07) 3785 ml2024-08-01NoNoCurrent