Drug Information

Product NDC: 65585-555

Proprietary Name: WhiskCare 355

Non Proprietary Name: Benzalkonium Chloride

Active Ingredient(s):

Administration Route(s): TOPICAL

Dosage Form(s): SOAP

Labeler Information

Labeler Name: Whisk Products, Inc.
Product Type: HUMAN OTC DRUG
FDA Application Number: part333E
Start Marketing Date:9/20/2007
End Marketing Date:6/30/2021

Package Information

No. Package Code Package Description Billing Unit
165585-555-013785 mL in 1 BOTTLE (65585-555-01)
265585-555-02236.6 mL in 1 BOTTLE, PUMP (65585-555-02)
365585-555-0359 mL in 1 TUBE (65585-555-03)
465585-555-05208198 mL in 1 DRUM (65585-555-05)
565585-555-066 BOTTLE, PLASTIC in 1 BOX (65585-555-06) > 1750 mL in 1 BOTTLE, PLASTIC
665585-555-074 BOTTLE, PLASTIC in 1 BOX (65585-555-07) > 4000 mL in 1 BOTTLE, PLASTIC
765585-555-088 BAG in 1 BOX (65585-555-08) > 1000 mL in 1 BAG
865585-555-0912 BAG in 1 BOX (65585-555-09) > 800 mL in 1 BAG

NDC Record

Field Name Field Value Definition
PRODUCT NDC65585-555The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN OTC DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMEWhiskCare 355The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEBenzalkonium ChlorideThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMESOAPThe translation of the dosage form Code submitted by the firm.
ROUTE NAMETOPICALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE9/20/2007This is the date that the labeler indicates was the start of its marketing of the drug product.
END MARKETING DATE6/30/2021This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
MARKETING CATEGORY NAMEOTC MONOGRAPH NOT FINALProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERpart333EThis corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEWhisk Products, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEBENZALKONIUM CHLORIDEThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

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This page was last updated on: 7/3/2020