NDC 80897-003 Incarvexx Essential Seawater

Nasal Decongestant

NDC Product Code 80897-003

NDC 80897-003-35

Package Description: 1 BOTTLE, SPRAY in 1 CARTON > 35 mL in 1 BOTTLE, SPRAY

NDC Product Information

Incarvexx Essential Seawater with NDC 80897-003 is a a human over the counter drug product labeled by Nobu Baby Llc. The generic name of Incarvexx Essential Seawater is nasal decongestant. The product's dosage form is spray and is administered via nasal form.

Labeler Name: Nobu Baby 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.

Incarvexx Essential Seawater 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.

  • IODINE .9 mg/100mL

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.

  • 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.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Nobu Baby Llc
Labeler Code: 80897
FDA Application Number: part333A 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 03-30-2020 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: 12-31-2021 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 - NO 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".

* Please review the disclaimer below.

Incarvexx Essential Seawater 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(S)

Iodine (0.02 %) Purpose Antiseptic Sodium Chloride (0.9%) Purpose Nasal Decongestant


Antiseptic, Aasal Decongestant


  • For cleaning the nasal cavity and the removal of the unpleasant mucusFor nasal irrigation


  • Apply 1-4 sprayings into each nostril up to 4 times a dayAs prevention use once a day with 2 sprayings


  • Use only as directedThe use of this dispenser by more than one person may spread infection

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Other Information

  • Store at room temperature between 68° and 77° F (20° to 25°C)

Inactive Ingredients

Sea water

* Please review the disclaimer below.