NDC 76168-602 Saline Nasal 1.5oz
Sodium Chloride 0.65%
NDC Product Code 76168-602
Proprietary Name: Saline Nasal 1.5oz 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 Chloride 0.65% 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.
Drug Use Information
Drug Use InformationThe drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.
- This product is used to treat dryness inside the nose (nasal passages). It helps add moisture inside the nose to dissolve and soften thick or crusty mucus. In babies and young children with stuffy noses who cannot blow their noses, using this product helps to make the mucus easier to remove with a nasal bulb syringe. This helps relieve stuffiness and makes breathing easier. This product contains a purified gentle salt solution (also called saline or sodium chloride solution). It does not contain any medication.
NDC Code Structure
- 76168 - Velocity Pharma Llc
- 76168-602 - Saline Nasal
NDC 76168-602-15
Package Description: 44 mL in 1 BOTTLE, SPRAY
NDC Product Information
Saline Nasal 1.5oz with NDC 76168-602 is a a human over the counter drug product labeled by Velocity Pharma Llc. The generic name of Saline Nasal 1.5oz is sodium chloride 0.65%. The product's dosage form is spray and is administered via nasal form.
Labeler Name: Velocity Pharma Llc
Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.
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.
Saline Nasal 1.5oz Active Ingredient(s)
What is the Active Ingredient(s) List?This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Inactive Ingredient(s)
About the Inactive Ingredient(s)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.
- BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
- SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
- BENZYL ALCOHOL (UNII: LKG8494WBH)
- SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)
- WATER (UNII: 059QF0KO0R)
Administration Route(s)
What are the Administration Route(s)?The translation of the route code submitted by the firm, indicating route of administration.
- Nasal - Administration to the nose; administered by way of the nose.
- Nasal - Administration to the nose; administered by way of the nose.
Product Labeler Information
What is the Labeler Name?Name of Company corresponding to the labeler code segment of the Product NDC.
Labeler Name: Velocity Pharma Llc
Labeler Code: 76168
FDA Application Number: part349 What is the FDA Application Number?
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.
Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 11-19-2019 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: 12-31-2020 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. Values = ‘Y’ or ‘N’.
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Saline Nasal 1.5oz Product Label Images
Saline Nasal 1.5oz Product Labeling Information
The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Product Labeling Index
Active Ingredient
Sodium Chloride, 0.65%
Purpose
Moisturizer
Uses
For dry nasal membranes
Warnings
Do not use if seal is broken or missing.
Directions
- Squeeze twice in each nostril as neededUpright delivers a spray, horizontally a stream, upside down a drop
Inactive Ingredients
Benzalkonium chloride, Disodium phosphate, Phenylcarbinol, Monosodium phosphate, Water
* Please review the disclaimer below.