NDC 0116-1061-01 Antiseptic Skin Cleanser

Chlorhexidine Gluconate

NDC Package Code 0116-1061-01

The NDC Code 0116-1061-01 is assigned to a package of 15142 ml in 1 jug of Antiseptic Skin Cleanser, a human over the counter drug labeled by Xttrium Laboratories, Inc.. The product's dosage form is solution and is administered via topical form.

Field Name Field Value
NDC Code 0116-1061-01
Package Description 15142 mL in 1 JUG
Proprietary Name Antiseptic Skin Cleanser What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Chlorhexidine Gluconate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Drug Uses This medication is used along with regular tooth brushing/flossing to treat gingivitis, a gum disease that causes red, swollen, and easily bleeding gums. Chlorhexidine belongs to a class of drugs known as antimicrobials. It works by decreasing the amount of bacteria in the mouth, helping to reduce swelling and redness of the gums and bleeding when you brush.
11-Digit NDC Billing Format 00116106101 NDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.
Product Type Human Otc Drug What kind of product is this?
Indicates 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.
Labeler Name Xttrium Laboratories, Inc.
Dosage Form Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route(s)
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
  • CHLORHEXIDINE GLUCONATE 4 g/100mL
  • CHLORHEXIDINE GLUCONATE 4 g/100mL
  • CHLORHEXIDINE GLUCONATE 4 g/100mL
Sample Package No Sample Package?
This field Indicates whether this package is a sample packaging or not.
Marketing Category NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product 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.
FDA Application Number NDA019125 What is the FDA Application Number?
This 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.
Start Marketing Date 08-31-2011 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
Listing Expiration Date 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
Exclude Flag N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

NDC Code Structure

  • 0116 - Xttrium Laboratories, Inc.
    • 0116-1061 - Antiseptic Skin Cleanser
      • 0116-1061-01 - 15142 mL in 1 JUG

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the disclaimer below.

Other Product Packages

The following packages are also available for Antiseptic Skin Cleanser with product NDC 0116-1061.

NDC Package CodePackage Description
0116-1061-04118 mL in 1 BOTTLE, PLASTIC
0116-1061-08237 mL in 1 BOTTLE, PLASTIC
0116-1061-1515 mL in 1 CARTON
0116-1061-16437 mL in 1 BOTTLE, PLASTIC
0116-1061-18532 mL in 1 BOTTLE
0116-1061-32946 mL in 1 BOTTLE, PLASTIC
0116-1061-40118 mL in 1 BOTTLE

* Please review the disclaimer below.