NDC 78976-003 Airdefender All Day Antibacterial Sanitizing Solution Refill Pack

Benzalkonium Chloride

NDC Product Code 78976-003

NDC CODE: 78976-003

Proprietary Name: Airdefender All Day Antibacterial Sanitizing Solution Refill Pack 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: Benzalkonium Chloride 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

  • 78976 - Airdefender International Company Limited
    • 78976-003 - Airdefender All Day Antibacterial Sanitizing Solution Refill Pack

NDC 78976-003-15

Package Description: 150 mL in 1 POUCH

NDC Product Information

Airdefender All Day Antibacterial Sanitizing Solution Refill Pack with NDC 78976-003 is a a human over the counter drug product labeled by Airdefender International Company Limited. The generic name of Airdefender All Day Antibacterial Sanitizing Solution Refill Pack is benzalkonium chloride. The product's dosage form is solution and is administered via topical form.

Labeler Name: Airdefender International Company Limited

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.

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.

Airdefender All Day Antibacterial Sanitizing Solution Refill Pack 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.


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)

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.

Labeler Name: Airdefender International Company Limited
Labeler Code: 78976
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: 01-27-2021 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: 12-31-2022 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.

Airdefender All Day Antibacterial Sanitizing Solution Refill Pack Product Label Images

Airdefender All Day Antibacterial Sanitizing Solution Refill Pack 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

Active Ingredient(S)

Benzalkonium Chloride 0.10%




Help reduce bacteria contact that potentially can cause disease.


For external use only.

Do Not Use

  • On open skin wounds

Otc - When Using

Keep out of eyes. In case of contact with eyes, rinse eye thoroughly with water.

Otc - Stop Use

Stop use and ask a doctor if irritation or rash occurs.

Otc - Keep Out Of Reach Of Children

If swallowed, drink water. Seek medical help if condition gets worse.


  • Spray onto hands or skin and apply evenly until dry.Remove large drops with clean towel within 15-20 seconds to avoid markings

Other Information

  • Store in room temperature. Avoid direct sunlight.Do not refrigerate.Use within 9 months after opening

Inactive Ingredients

Titanium Dioxide, Purified Water

* Please review the disclaimer below.