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NDC 63868-903 Quality Choice Original Eye Drops

Tetrahydrozoline Hydrochloride Solution Ophthalmic - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 63868-903?
  4. Quality Choice Original Eye Drops Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

NDC Product Code:
63868-903
Proprietary Name:
Quality Choice Original Eye Drops
Non-Proprietary Name: [1]
Tetrahydrozoline Hydrochloride
Substance Name: [2]
Tetrahydrozoline Hydrochloride
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route(s): [4]
  • Ophthalmic - Administration to the external eye.
    • Labeler Name: [5]
    Chain Drug Marketing Association Inc
    Labeler Code:
    63868
    Product Label ID:
    253fb4ed-e6e7-4dee-b2c3-364ccf36dde6
    FDA Application Number: [6]
    part349
    Marketing Category: [8]
    OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
    Start Marketing Date: [9]
    09-30-2012
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Code Structure Chart

    Product Details

    What is NDC 63868-903?

    The NDC code 63868-903 is assigned by the FDA to the product Quality Choice Original Eye Drops which is a human over the counter drug product labeled by Chain Drug Marketing Association Inc. The generic name of Quality Choice Original Eye Drops is tetrahydrozoline hydrochloride. The product's dosage form is solution and is administered via ophthalmic form. The product is distributed in a single package with assigned NDC code 63868-903-15 1 bottle in 1 carton / 15 ml in 1 bottle. 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 Quality Choice Original Eye Drops?

    Directionsto open bottle, push cap down and twist counterclockwise. To close bottle, twist clockwise until it stops turningput 1 to 2 drops in the affected eye(s) up to 4 times dailychildren under 6 years of age: ask a doctor

    What are Quality Choice Original Eye Drops Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    Which are Quality Choice Original Eye Drops UNII Codes?

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

    • TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D)
    • TETRAHYDROZOLINE (UNII: S9U025Y077) (Active Moiety)

    Which are Quality Choice Original Eye Drops 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 Quality Choice Original Eye Drops?

    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: 1052943 - tetrahydrozoline HCl 0.05 % Ophthalmic Solution
    • RxCUI: 1052943 - tetrahydrozoline hydrochloride 0.5 MG/ML Ophthalmic Solution
    • RxCUI: 1052943 - tetrahydrozoline hydrochloride 0.05 % Eye Drops
    • RxCUI: 1052943 - tetrahydrozoline hydrochloride 0.05 % Ophthalmic Solution

    * Please review the disclaimer below.

    Patient Education

    Tetrahydrozoline Ophthalmic


    Ophthalmic tetrahydrozoline is used to relieve minor eye irritation and redness caused by colds, pollen, and swimming.
    [Learn More]


    * 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.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [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".