FDA.reportPublic FDA data

WhiskCare 387

Product NDC
65585-513
Requested package NDC
65585-513-02
11-digit product format
655850513
Labeler code
65585
Product ID
65585-513_35bcd8fb-5ef8-8802-e063-6394a90aa833
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
2020-04-15
Marketing end
2027-06-30
Substance
BENZALKONIUM CHLORIDE
Active strength
1 mg/mL
NDC exclude flag
No
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage65585-51365585-513-02DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Additional Listing Data#

Finished product
Yes
Brand name base
WhiskCare 387

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
8fa2a6c1-f9f3-4895-861e-82d4d68e54c4Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65585-513-01WhiskCare 38750 mL in 1 BOTTLE, PUMPSOAP5012
65585-513-02WhiskCare 3876 in 1 BOXSOAP612
65585-513-02WhiskCare 3871000 mL in 1 BAGSOAP100012
65585-513-03WhiskCare 3871000 mL in 1 BAGSOAP100012
65585-513-03WhiskCare 3878 in 1 BOXSOAP812
65585-513-04WhiskCare 387500 mL in 1 BOTTLE, PUMPSOAP50012
65585-513-04WhiskCare 3876 in 1 BOXSOAP612
65585-513-05WhiskCare 3876 in 1 BOXSOAP612
65585-513-05WhiskCare 3871750 mL in 1 BOTTLE, PUMPSOAP175012
65585-513-06WhiskCare 3873785 mL in 1 BOTTLE, PLASTICSOAP378512
65585-513-07WhiskCare 3871000 mL in 1 BAGSOAP100012
65585-513-07WhiskCare 3874 in 1 BOXSOAP412
65585-513-08WhiskCare 3871000 mL in 1 BAGSOAP100012
65585-513-08WhiskCare 3874 in 1 BOXSOAP412
65585-513-09WhiskCare 3871000 mL in 1 BAGSOAP100012
65585-513-09WhiskCare 3873 in 1 BOXSOAP312

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65585-513WHISKCARE 387 (BENZALKONIUM CHLORIDE) SOAP [WHISK PRODUCTS, INC.]12Current NDC, Legacy NDC, 16 package rows20250523_8fa2a6c1-f9f3-4895-861e-82d4d68e54c4.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.8fa2a6c1-f9f3-4895-861e-82d4d68e54c42025-05-22WarningsExact identifier
ndc (package): 65585-513-02
ndc (product): 65585-513
ndc11 (package): 65585051302

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1233282benzalkonium chloride 0.1 % Medicated Liquid SoapPSN8fa2a6c1-f9f3-4895-861e-82d4d68e54c412
1233282benzalkonium chloride 1 MG/ML Medicated Liquid SoapSCD8fa2a6c1-f9f3-4895-861e-82d4d68e54c412
1233282benzalkonium chloride 0.1 % Medicated Liquid SoapSY8fa2a6c1-f9f3-4895-861e-82d4d68e54c412

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65585-513-02655850513026 BAG in 1 BOX (65585-513-02) > 1000 mL in 1 BAG6 bag2020-04-150000-00-00NoNoCurrent