42829-408 NDC - SINUCLEANSE (SODIUM BICARBONATE, SODIUM CHLORIDE)

Drug Information

Product NDC: 42829-408

Proprietary Name: SinuCleanse

Non Proprietary Name: SODIUM BICARBONATE, SODIUM CHLORIDE

Active Ingredient(s):
  • 22.2 mg/100mg SODIUM BICARBONATE;
  • 77.8 mg/100mg SODIUM CHLORIDE


Administration Route(s): NASAL

Dosage Form(s): POWDER, FOR SOLUTION

Pharmacy Class(es):
  • Increased Large Intestinal Motility [PE];
  • Increased Large Intestinal Motility [PE];
  • Inhibition Large Intestine Fluid/Electrolyte Absorption [PE];
  • Inhibition Large Intestine Fluid/Electrolyte Absorption [PE];
  • Osmotic Activity [MoA];
  • Osmotic Activity [MoA];
  • Osmotic Laxative [EPC];
  • Osmotic Laxative [EPC]

Labeler Information

Labeler Name: ASCENT CONSUMER PRODUCTS, INC.
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED DRUG OTHER
Start Marketing Date:2/1/2015

Package Information

No. Package Code Package Description Billing Unit
142829-408-00100 PACKET in 1 CARTON (42829-408-00) / 3000 mg in 1 PACKET
242829-408-6060 PACKET in 1 CARTON (42829-408-60) / 3000 mg in 1 PACKET

NDC Record

Field Name Field Value Definition
PRODUCT NDC42829-408The 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.
PRODUCT TYPE NAMEHUMAN OTC DRUGIndicates 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.
PROPRIETARY NAMESinuCleanseThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMESODIUM BICARBONATE, SODIUM CHLORIDEThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEPOWDER, FOR SOLUTIONThe translation of the dosage form Code submitted by the firm.
ROUTE NAMENASALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE2/1/2015This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEUNAPPROVED DRUG OTHERProduct 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.
LABELER NAMEASCENT CONSUMER PRODUCTS, INC.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMESODIUM BICARBONATE; SODIUM CHLORIDEAn 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.
ACTIVE NUMERATOR STRENGTH22.2; 77.8 
ACTIVE INGRED UNITmg/100mg; mg/100mg 
PHARM CLASSESIncreased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC] 
PRODUCT NDC42829-408The 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.
PRODUCT TYPE NAMEHUMAN OTC DRUGIndicates 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.
PROPRIETARY NAMESinuCleanseThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMESODIUM BICARBONATE, SODIUM CHLORIDEThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEPOWDER, FOR SOLUTIONThe translation of the dosage form Code submitted by the firm.
ROUTE NAMENASALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE2/1/2015This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEUNAPPROVED DRUG OTHERProduct 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.
LABELER NAMEASCENT CONSUMER PRODUCTS, INC.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMESODIUM BICARBONATE; SODIUM CHLORIDEAn 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.
ACTIVE NUMERATOR STRENGTH22.2; 77.8 
ACTIVE INGRED UNITmg/100mg; mg/100mg 
PHARM CLASSESIncreased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC] 

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This page was last updated on: 2/1/2023