37000-616 NDC - DAWN ULTRA ANTIBACTERIAL HAND (CHLOROXYLENOL)

Drug Information

Product NDC: 37000-616

Proprietary Name: Dawn Ultra Antibacterial Hand

Non Proprietary Name: Chloroxylenol

Active Ingredient(s):
  • .3 g/100mL CHLOROXYLENOL


Administration Route(s): TOPICAL

Dosage Form(s): SOAP

Labeler Information

Labeler Name: The Procter & Gamble Manufacturing Company
Product Type: HUMAN OTC DRUG
FDA Application Number: M005
Marketing Category: OTC MONOGRAPH FINAL
Start Marketing Date:7/7/2014

Package Information

No. Package Code Package Description Billing Unit
137000-616-161660 mL in 1 BOTTLE, PLASTIC (37000-616-16)
237000-616-19192 mL in 1 BOTTLE, PLASTIC (37000-616-19)
337000-616-20207 mL in 1 BOTTLE, PLASTIC (37000-616-20)
437000-616-21221 mL in 1 BOTTLE, PLASTIC (37000-616-21)
537000-616-222210 mL in 1 BOTTLE, PLASTIC (37000-616-22)
637000-616-381120 mL in 1 BOTTLE, PLASTIC (37000-616-38)
737000-616-401200 mL in 1 BOTTLE, PLASTIC (37000-616-40)
837000-616-45458 mL in 1 BOTTLE, PLASTIC (37000-616-45)
937000-616-47479 mL in 1 BOTTLE, PLASTIC (37000-616-47)
1037000-616-57573 mL in 1 BOTTLE, PLASTIC (37000-616-57)
1137000-616-63638 mL in 1 BOTTLE, PLASTIC (37000-616-63)
1237000-616-71709 mL in 1 BOTTLE, PLASTIC (37000-616-71)
1337000-616-82828 mL in 1 BOTTLE, PLASTIC (37000-616-82)
1437000-616-902660 mL in 1 BOTTLE, PLASTIC (37000-616-90)

NDC Record

Field Name Field Value Definition
PRODUCT NDC37000-616The 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 NAMEDawn Ultra Antibacterial HandThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PROPRIETARY NAME SUFFIXApple Blossom ScentA suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard.
NON PROPRIETARY NAMEChloroxylenolThe 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 DATE7/7/2014This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEOTC MONOGRAPH 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 NUMBERM005This 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 NAMEThe Procter & Gamble Manufacturing CompanyName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMECHLOROXYLENOLAn 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.3 
ACTIVE INGRED UNITg/100mL 

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