NDC 55910-919-20 Rexall Sinus Wash System Soft Tip Squeeze Bottle

Sodium Bicarbonate, Sodium Chloride

NDC Package Code 55910-919-20

The NDC Code 55910-919-20 is assigned to a package of 1 kit in 1 kit * 3000 mg in 1 packet (55910-543-20) of Rexall Sinus Wash System Soft Tip Squeeze Bottle, a human over the counter drug labeled by Dolgencorp, Llc. The product's dosage form is kit and is administered via nasal form.

Field Name Field Value
NDC Code 55910-919-20
Package Description 1 KIT in 1 KIT * 3000 mg in 1 PACKET (55910-543-20)
Proprietary Name Rexall Sinus Wash System Soft Tip Squeeze Bottle 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 Bicarbonate, 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.
11-Digit NDC Billing Format 55910091920 NDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.
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.
Labeler Name Dolgencorp, Llc
Dosage Form Kit - A packaged collection of related material.
Administration Route(s)
  • Nasal - Administration to the nose; administered by way of the nose.
Sample Package No Sample Package?
This field Indicates whether this package is a sample packaging or not.
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 05-17-2021 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 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".

NDC Code Structure

  • 55910 - Dolgencorp, Llc
    • 55910-919 - Rexall Sinus Wash System
      • 55910-919-20 - 1 KIT in 1 KIT * 3000 mg in 1 PACKET (55910-543-20)

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

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