NDC 42829-505 Sinucleanse Sterile Saline Mist

Sodium Chloride

NDC Product Code 42829-505

NDC CODE: 42829-505

Proprietary Name: Sinucleanse Sterile Saline Mist 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: Sodium 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This product is used to treat dryness inside the nose (nasal passages). It helps add moisture inside the nose to dissolve and soften thick or crusty mucus. In babies and young children with stuffy noses who cannot blow their noses, using this product helps to make the mucus easier to remove with a nasal bulb syringe. This helps relieve stuffiness and makes breathing easier. This product contains a purified gentle salt solution (also called saline or sodium chloride solution). It does not contain any medication.

NDC Code Structure

  • 42829 - Ascent Consumer Products, Inc

NDC 42829-505-60

Package Description: 129 g in 1 BOTTLE, SPRAY

NDC Product Information

Sinucleanse Sterile Saline Mist with NDC 42829-505 is a a human over the counter drug product labeled by Ascent Consumer Products, Inc. The generic name of Sinucleanse Sterile Saline Mist is sodium chloride. The product's dosage form is spray and is administered via nasal form.

Labeler Name: Ascent Consumer Products, Inc

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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.

Sinucleanse Sterile Saline Mist 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.

  • SODIUM CHLORIDE 3 g/100g

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.

  • Nasal - Administration to the nose; administered by way of the nose.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Ascent Consumer Products, Inc
Labeler Code: 42829
Marketing Category: UNAPPROVED DRUG OTHER - 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: 03-13-2021 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 - NO 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".

* Please review the disclaimer below.

Sinucleanse Sterile Saline Mist 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

Sodium Chloride 3%Sterile, Hypertonic Saline Solution,Sodium Bicarbonate to adjust pH


Nasal Wash


  • Nasal congestionRemoves inhaled irritants (dust, dirt, pollen)Moisturizes dry nasal passages


Adults and children 4 years and over: Use as often as needed

Children under 4 years: Consult a physician

See directions on can for complere instructions

For nasal use only.Before use, expel a shoet stream of mist into the air. Insert tip of nozzle into one nostril and press down on the textured area at the base of the nozzle so that a gentle mist coats nasal passages. Blow your nose very gently to clear the mucus out. Repeat for the other nostriil.To flush and irrigate, tilt head to the side over sink. Insert top of nozzle into the top nostril, pressing down on the textured area at the base of the nozzle so that a gentle mist fills sinus passages and flows out the opposite nostril. Repeat in other nostril.Wipe nozzle after each use.


WarningsUse of this product by more than one person may spread infection

Contents under pressure

Do not puncture or incinerate

Avoid spraying in eyes

Other Information

Store between 59 and 86 degree F

Inactive Ingredients

Purfied Water

Questions ?


* Please review the disclaimer below.