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NDC 69968-0844 Visine Red Eye Total Comfort And Tears Dry Eye Relief

Tetrahydrozoline Hcl,Polyethylene Glycol 400,Zinc Sulfate Kit - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 69968-0844?
  4. Visine Red Eye Total Comfort And Tears Dry Eye Relief Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk

Product Information

NDC Product Code:
69968-0844
Proprietary Name:
Visine Red Eye Total Comfort And Tears Dry Eye Relief
Non-Proprietary Name: [1]
Tetrahydrozoline Hcl, Polyethylene Glycol 400, Zinc Sulfate
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Kit - A packaged collection of related material.
Labeler Name: [5]
Johnson & Johnson Consumer Inc.
Labeler Code:
69968
Product Label ID:
0bc0d6e7-9195-db6b-e063-6294a90aef04
FDA Application Number: [6]
M018
Marketing Category: [8]
OTC MONOGRAPH DRUG -
Start Marketing Date: [9]
06-08-2020
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
N
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Product Details

What is NDC 69968-0844?

The NDC code 69968-0844 is assigned by the FDA to the product Visine Red Eye Total Comfort And Tears Dry Eye Relief which is a human over the counter drug product labeled by Johnson & Johnson Consumer Inc.. The generic name of Visine Red Eye Total Comfort And Tears Dry Eye Relief is tetrahydrozoline hcl, polyethylene glycol 400, zinc sulfate. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 69968-0844-9 1 kit in 1 package * 1 bottle, dropper in 1 carton (69968-0360-1) / 15 ml in 1 bottle, dropper * 1 bottle, dropper in 1 carton (69968-0363-1) / 15 ml in 1 bottle, dropper. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Visine Red Eye Total Comfort And Tears Dry Eye Relief?

• adults and children 6 years of age and over: put 1 or 2 drops in the affected eye(s) up to 4 times a day• children under 6 years of age: consult a doctor• children under 2 years of age: do not use • adults and children 6 years of age and over: put 1 or 2 drops in the affected eye(s) as needed• children under 6 years of age: consult a doctor

Which are Visine Red Eye Total Comfort And Tears Dry Eye Relief UNII Codes?

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

  • TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D)
  • TETRAHYDROZOLINE (UNII: S9U025Y077) (Active Moiety)
  • ZINC SULFATE, UNSPECIFIED FORM (UNII: 89DS0H96TB)
  • ZINC CATION (UNII: 13S1S8SF37) (Active Moiety)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (Active Moiety)

Which are Visine Red Eye Total Comfort And Tears Dry Eye Relief Inactive Ingredients 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 Visine Red Eye Total Comfort And Tears Dry Eye Relief?

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: 2360899 - polyethylene glycol 400 1 % Ophthalmic Solution
  • RxCUI: 2360899 - polyethylene glycol 400 10 MG/ML Ophthalmic Solution
  • RxCUI: 2360903 - polyethylene glycol 400 1 % / tetrahydrozoline hydrochloride 0.05 % / zinc sulfate 0.25 % Ophthalmic Solution
  • RxCUI: 2360903 - polyethylene glycol 400 10 MG/ML / tetrahydrozoline hydrochloride 0.5 MG/ML / zinc sulfate 2.5 MG/ML Ophthalmic Solution
  • RxCUI: 2360903 - polyethylene glycol 400 10 MG/ML / tetrahydrozoline hydrochloride 0.5 MG/ML / ZnSO4 2.5 MG/ML Ophthalmic Solution

* Please review the disclaimer below.

Product Footnotes

[1] 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.

[3] 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.

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

[6] 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.

[8] 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.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] 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.

[12] 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".