NDC 42829-408 Sinucleanse

Sodium Bicarbonate,Sodium Chloride Powder, For Solution Nasal - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
42829-408
Proprietary Name:
Sinucleanse
Non-Proprietary Name: [1]
Sodium Bicarbonate, Sodium Chloride
Substance Name: [2]
Sodium Bicarbonate; Sodium Chloride
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Powder, For Solution - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a solution.
Administration Route(s): [4]
  • Nasal - Administration to the nose; administered by way of the nose.
  • Nasal - Administration to the nose; administered by way of the nose.
  • Labeler Name: [5]
    Ascent Consumer Products, Inc.
    Labeler Code:
    42829
    Marketing Category: [8]
    UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
    Start Marketing Date: [9]
    02-01-2015
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 42829-408-00

    Package Description: 100 PACKET in 1 CARTON / 3000 mg in 1 PACKET

    NDC Code 42829-408-60

    Package Description: 60 PACKET in 1 CARTON / 3000 mg in 1 PACKET

    Product Details

    What is NDC 42829-408?

    The NDC code 42829-408 is assigned by the FDA to the product Sinucleanse which is a human over the counter drug product labeled by Ascent Consumer Products, Inc.. The generic name of Sinucleanse is sodium bicarbonate, sodium chloride. The product's dosage form is powder, for solution and is administered via nasal form. The product is distributed in 2 packages with assigned NDC codes 42829-408-00 100 packet in 1 carton / 3000 mg in 1 packet, 42829-408-60 60 packet in 1 carton / 3000 mg in 1 packet. 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 Sinucleanse?

    UsesTemporarily relieves symptoms associated withsinusitis, cold, flu or allergies:-Sneezing-Runny nose-Nasal stuffiness-Post nasal drip-Removes inhaled irritants (dust, pollen)-Promotes nasal and sinus drainage-Helps reduce swelling of nasal membranes-Moisturizes dry nasal passages

    What are Sinucleanse 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 Sinucleanse UNII Codes?

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

    Which are Sinucleanse 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 Sinucleanse?

    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: 1542919 - sodium bicarbonate 700 MG / sodium chloride 2300 MG Powder for Nasal Solution
    • RxCUI: 1542919 - NaHCO3 700 MG / NaCl 2300 MG Powder for Nasal Solution

    Which are the Pharmacologic Classes for Sinucleanse?

    * Please review the disclaimer below.

    Product Footnotes

    [1] 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.

    [2] 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.

    [3] 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

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

    [8] 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.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] 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] 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".