FDA.reportPublic FDA data

WhiskCare 377

Product NDC
65585-356
11-digit product format
655850356
Labeler code
65585
Product ID
65585-356_2206420a-400e-3a5f-e063-6394a90a49fd
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
2024-02-22
Marketing end
2027-08-01
Substance
BENZALKONIUM CHLORIDE
Active strength
1 mg/mL
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
WhiskCare 377

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF5UM2KM3W7
Rxcui1038799

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65585-356-01WhiskCare 37750 mL in 1 BOTTLE, PUMPSOLUTION503
65585-356-02WhiskCare 37724 in 1 BOTTLESOLUTION243
65585-356-02WhiskCare 37750 mL in 1 BOTTLE, PUMPSOLUTION503
65585-356-03WhiskCare 377208198 mL in 1 DRUMSOLUTION2081983
65585-356-04WhiskCare 3771000 mL in 1 BAGSOLUTION10003
65585-356-04WhiskCare 3774 in 1 BOXSOLUTION43
65585-356-05WhiskCare 3778 in 1 BOXSOLUTION83
65585-356-05WhiskCare 3771000 mL in 1 BAGSOLUTION10003
65585-356-06WhiskCare 377550 mL in 1 BOTTLE, PUMPSOLUTION5503
65585-356-06WhiskCare 3776 in 1 BOXSOLUTION63
65585-356-07WhiskCare 3776 in 1 BOXSOLUTION63
65585-356-07WhiskCare 3771750 mL in 1 BOTTLE, PUMPSOLUTION17503
65585-356-08WhiskCare 3773785 mL in 1 BOTTLE, PLASTICSOLUTION37853

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65585-356WHISKCARE 377 (BENZALKONIUM CHLORIDE) SOLUTION [WHISK PRODUCTS, INC.]3Current NDC, 13 package rows20240915_124b403f-d12e-6e5c-e063-6394a90a63f8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038799benzalkonium chloride 0.1 % Topical FoamPSN124b403f-d12e-6e5c-e063-6394a90a63f83
1038799benzalkonium chloride 1 MG/ML Topical FoamSCD124b403f-d12e-6e5c-e063-6394a90a63f83
1038799benzalkonium chloride 0.1 % Topical FoamSY124b403f-d12e-6e5c-e063-6394a90a63f83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65585-356-016558503560150 mL in 1 BOTTLE, PUMP (65585-356-01) 50 ml2024-02-222027-08-01YesNoHistorical
65585-356-026558503560224 BOTTLE, PUMP in 1 BOTTLE (65585-356-02) / 50 mL in 1 BOTTLE, PUMP2024-02-222027-08-01NoNoHistorical
65585-356-0365585035603208198 mL in 1 DRUM (65585-356-03) 208198 ml2024-02-222027-08-01NoNoHistorical
65585-356-04655850356044 BAG in 1 BOX (65585-356-04) / 1000 mL in 1 BAG4 bag2024-02-222027-08-01NoNoHistorical
65585-356-05655850356058 BAG in 1 BOX (65585-356-05) / 1000 mL in 1 BAG8 bag2024-02-222027-08-01NoNoHistorical
65585-356-06655850356066 BOTTLE, PUMP in 1 BOX (65585-356-06) / 550 mL in 1 BOTTLE, PUMP2024-02-222027-08-01NoNoHistorical
65585-356-07655850356076 in 1 BOXHistorical
65585-356-08655850356083785 mL in 1 BOTTLE, PLASTIC (65585-356-08) 3785 ml2024-02-222027-08-01NoNoHistorical