NDC 0116-0161 Antiseptic Skin Cleanser
Chlorhexidine Gluconate 4% Liquid Topical

Table of Contents

    1. Product Information
    2. Product Packages
    3. What is NDC 0116-0161?
    4. Antiseptic Skin Cleanser Uses
    5. Active Ingredients
    6. Active Ingredients UNII Codes
    7. Inactive Ingredients UNII Codes
    8. NDC to RxNorm Crosswalk
    9. Pharmacologic Classes

Product Information

NDC Product Code0116-0161
Proprietary Name 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.		Antiseptic Skin Cleanser
Non-Proprietary Name 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.		Chlorhexidine Gluconate 4%
Substance Name What is the Substance Name?
An 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.		Chlorhexidine Gluconate
Product Type 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.		Human Otc Drug
NDC Directory StatusACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage FormLiquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		Xttrium Laboratories, Inc.
Labeler Code0116
SPL SET ID:4ab2cfc2-7adb-20c4-e054-00144ff8d46c
FDA Application Number 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.		NDA019125
Marketing Category 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.		NDA - A product marketed under an approved New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		05-01-2011
Listing Expiration Date 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.		12-31-2023
Exclude Flag 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". 		N
NDC Code Structure

Product Packages

NDC Code 0116-0161-08

Package Description: 237 mL in 1 BOTTLE, PLASTIC

NDC Code 0116-0161-15

Package Description: 15 mL in 1 KIT

NDC Code 0116-0161-16

Package Description: 473 mL in 1 BOTTLE, PUMP

Product Details

What is NDC 0116-0161?

The NDC code 0116-0161 is assigned by the FDA to the product Antiseptic Skin Cleanser which is a human over the counter drug product labeled by Xttrium Laboratories, Inc.. The generic name of Antiseptic Skin Cleanser is chlorhexidine gluconate 4%. The product's dosage form is liquid and is administered via topical form. The product is distributed in 3 packages with assigned NDC codes 0116-0161-08 237 ml in 1 bottle, plastic , 0116-0161-15 15 ml in 1 kit , 0116-0161-16 473 ml in 1 bottle, pump . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Antiseptic Skin Cleanser?

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.

What are Antiseptic Skin Cleanser Active Ingredients?

An 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.

Which are Antiseptic Skin Cleanser UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Antiseptic Skin Cleanser Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Antiseptic Skin Cleanser?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 211365 - chlorhexidine gluconate 4 % Medicated Liquid Soap
  • RxCUI: 211365 - chlorhexidine gluconate 40 MG/ML Medicated Liquid Soap
  • RxCUI: 211365 - chlorhexidine gluconate 4 % Medicated Surgical Scrub

Which are the Pharmacologic Classes for Antiseptic Skin Cleanser?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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Product Label

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