53247-113 NDC - BOB BARKER ANTIBACTERIAL UNWRAPPED BODY (BENZETHONIUM CHLORIDE)

Drug Information

Product NDC: 53247-113

Proprietary Name: Bob Barker Antibacterial unwrapped body

Non Proprietary Name: BENZETHONIUM CHLORIDE

Active Ingredient(s):
  • .1 g/100g BENZETHONIUM CHLORIDE


Administration Route(s): CUTANEOUS

Dosage Form(s): SOAP

Labeler Information

Labeler Name: Bob Barker Company Inc.
Product Type: HUMAN OTC DRUG
FDA Application Number: part333E
Marketing Category: OTC MONOGRAPH NOT FINAL
Start Marketing Date:6/1/2017

Package Information

No. Package Code Package Description Billing Unit
153247-113-011000 APPLICATOR in 1 CASE (53247-113-01) / 11 g in 1 APPLICATOR
253247-113-02500 APPLICATOR in 1 CASE (53247-113-02) / 32 g in 1 APPLICATOR
353247-113-03144 APPLICATOR in 1 CASE (53247-113-03) / 75 g in 1 APPLICATOR
453247-113-04200 APPLICATOR in 1 CASE (53247-113-04) / 85 g in 1 APPLICATOR

NDC Record

Field Name Field Value Definition
PRODUCT NDC53247-113The 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 NAMEBob Barker Antibacterial unwrapped bodyThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEBENZETHONIUM 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 NAMECUTANEOUSThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE6/1/2017This is the date that the labeler indicates was the start of its marketing of the drug product.
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 NAMEBob Barker Company Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEBENZETHONIUM CHLORIDEAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH.1 
ACTIVE INGRED UNITg/100g 

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This page was last updated on: 2/1/2023