| PRODUCT NDC | 79481-0502 | The translation of the dosage form Code submitted by the firm. |
| PRODUCT TYPE NAME | HUMAN OTC DRUG | 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. |
| PROPRIETARY NAME | Sinus Wash Saline Refills | This is the date that the labeler indicates was the start of its marketing of the drug product. |
| PROPRIETARY NAME SUFFIX | Meijer | 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. |
| NON PROPRIETARY NAME | SODIUM BICARBONATE, SODIUM CHLORIDE | 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. |
| DOSAGE FORM NAME | POWDER, FOR SOLUTION | Name of Company corresponding to the labeler code segment of the Product NDC. |
| ROUTE NAME | NASAL | 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. |
| START MARKETING DATE | 1/8/2022 | This is the date that the labeler indicates was the start of its marketing of the drug product. |
| MARKETING CATEGORY NAME | UNAPPROVED DRUG OTHER | 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. |
| LABELER NAME | Meijer, Inc. | Name of Company corresponding to the labeler code segment of the Product NDC. |
| SUBSTANCE NAME | SODIUM BICARBONATE; SODIUM CHLORIDE | 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. |
| ACTIVE NUMERATOR STRENGTH | 700; 2300 | |
| ACTIVE INGRED UNIT | mg/3000mg; mg/3000mg | |
| PHARM CLASSES | 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] | |