Soft Tip Squeeze Bottle Sinus Wash Kit
NDC 68016-452

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 68016-452?
  4. Soft Tip Squeeze Bottle Sinus Wash Premier Value Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk

Product Information

Soft Tip Squeeze Bottle Sinus Wash (sodium bicarbonate, sodium chloride) is a UNAPPROVED DRUG OTHER-approved product labeled by Premier Value. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a kit for nasal administration. This product entry covers the primary NDC 68016-452 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
68016-452
Proprietary Name:
Soft Tip Squeeze Bottle Sinus Wash Premier Value
Non-Proprietary Name: [1]
Sodium Bicarbonate, Sodium Chloride
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Kit - A packaged collection of related material.
Administration Route(s): [4]
Nasal - Administration to the nose; administered by way of the nose.

Labeler & Regulatory Data

Labeler Name: [5]
Premier Value
Labeler Code:
68016
Product Label ID:
dd7437ea-0996-0802-e053-2995a90aaa83
Marketing Category: [8]
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.

Marketing Timeline

Start Marketing Date: [9]
01-09-2022
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 68016-452?

The NDC code 68016-452 is assigned by the FDA to the product Soft Tip Squeeze Bottle Sinus Wash Premier Value. It is commonly known by its generic name, sodium bicarbonate, sodium chloride. This pharmaceutical product is labeled by Premier Value and is currently categorized as listed product. The medication is a kit administered via nasal route. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 68016-452-01, 68016-452-01. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

UsesTemporarily relieves symptoms associated withsinusitis, cold, flu or allergies-Sneezing-Nasal Stuffiness-Runny nose-Post nasal dripRemoves inhaled irritants (dust, pollen)Removes nasal and sinus drainageHelps reduce swelling of nasal membranesMoisturizes dry nasal passages

Which are the associated UNII Codes?

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

Which are the Inactive Ingredients associated 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 this product?

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

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Product & Regulatory Definitions
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.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".