Sinucleanse Nasal Drip

Sodium Chloride


Ascent Consumer Products, Inc
Human Otc Drug
NDC 42829-407
Sinucleanse Nasal Drip also known as Sodium Chloride is a human otc drug labeled by 'Ascent Consumer Products, Inc'. National Drug Code (NDC) number for Sinucleanse Nasal Drip is 42829-407. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Sinucleanse Nasal Drip drug includes Sodium Chloride - .9 mg/100mL . The currest status of Sinucleanse Nasal Drip drug is Active.

Drug Information:

Drug NDC: 42829-407
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Sinucleanse Nasal Drip
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Sodium Chloride
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Ascent Consumer Products, Inc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Gel
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:SODIUM CHLORIDE - .9 mg/100mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:NASAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: UNAPPROVED DRUG OTHER
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date: 08 Jan, 2022
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 16 Jan, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Listing Expiration Date: 31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:ASCENT CONSUMER PRODUCTS, INC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:351179
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
UNII:451W47IQ8X
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
42829-407-1030 mL in 1 BOTTLE, SPRAY (42829-407-10)08 Jan, 2022N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Purpose:

Purpose nasal moisturizer

Product Elements:

Sinucleanse nasal drip sodium chloride water sodium chloride chloride ion allantoin glycerin benzalkonium chloride aloe vera leaf propylene glycol hyaluronate sodium

Indications and Usage:

Uses provides moisture to soothe and hydrate dry nasal passages caused by indoor heat, dry climate, air travel, high altitude, oxygen use, cpap machineuse

Warnings:

Warnings warnings -stop use and ask a doctor if use is uncomfortable or dryness persists -do not use if allergic to any of the ingredients -do not use if the safety seal is missing or broken - for nasal use only, do not use for dry mouth

Dosage and Administration:

Directions 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.

Package Label Principal Display Panel:

Product label gel

Further Questions:

Questions ? 1-888-547-5492


Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.