NDC 77396-001 Sanivir Hands, Body, And Surfaces Sanitizer

Didecyldimonium Chloride And Benzalkonium Chloride Liquid

NDC Product Code 77396-001

NDC CODE: 77396-001

Proprietary Name: Sanivir Hands, Body, And Surfaces Sanitizer 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: Didecyldimonium Chloride And Benzalkonium Chloride Liquid 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.

NDC Code Structure

NDC 77396-001-01

Package Description: 1000 L in 1 CONTAINER

NDC 77396-001-02

Package Description: 5 L in 1 BOTTLE, PLASTIC

NDC 77396-001-03

Package Description: .075 L in 1 BOTTLE, PLASTIC

NDC Product Information

Sanivir Hands, Body, And Surfaces Sanitizer with NDC 77396-001 is a a human over the counter drug product labeled by Kemix Quimica, S.a. De C.v.. The generic name of Sanivir Hands, Body, And Surfaces Sanitizer is didecyldimonium chloride and benzalkonium chloride liquid. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Kemix Quimica, S.a. De C.v.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Sanivir Hands, Body, And Surfaces Sanitizer Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • DIDECYLDIMONIUM CHLORIDE 2.5 mg/.001L
  • BENZALKONIUM CHLORIDE 1 mg/.001L

Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.

  • WATER (UNII: 059QF0KO0R)
  • MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • METHYL ALCOHOL (UNII: Y4S76JWI15)
  • GLYCERIN (UNII: PDC6A3C0OX)

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.
  • 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.

Labeler Name: Kemix Quimica, S.a. De C.v.
Labeler Code: 77396
FDA Application Number: part333A 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.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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.

Start Marketing Date: 05-07-2020 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Sanivir Hands, Body, And Surfaces Sanitizer Product Label Images

Sanivir Hands, Body, And Surfaces Sanitizer Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Sanivir Hands, Body, And Surfaces Sanitizer 1,000 Lt (264 Gallons)

1000 Lt NDC: 77396-001-01

Sanivir Hands, Body, And Surfaces Sanitizer 5Lt (1.32 Gallons)

5 Lt NDC: 77396-001-02

Sanivir Hands, Body, And Surfaces Sanitizer 75Ml (2.4Fl.Oz)

NDC: 77396-01-003

Sanivir Gel Plus Sanitizer 75Ml (2.4Fl.Oz)

NDC: 77396-002-02

Sanivir Gel Plus Sanitizer 5Lt (1.32Gal)

NDC: 77396-002-01

* Please review the disclaimer below.