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  4. NDC Product Code: 64108-313 Ocufresh

NDC 64108-313 Ocufresh

Water Liquid Ophthalmic - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 64108-313?
  4. Ocufresh Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

NDC Product Code:
64108-313
Proprietary Name:
Ocufresh
Non-Proprietary Name: [1]
Water
Substance Name: [2]
Water
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route(s): [4]
  • Ophthalmic - Administration to the external eye.
    • Labeler Name: [5]
    Optics Laboratory Inc.
    Labeler Code:
    64108
    Product Label ID:
    b8e477a9-66b9-496b-92fb-3d4bbd7b36b5
    FDA Application Number: [6]
    M018
    Marketing Category: [8]
    OTC MONOGRAPH DRUG -
    Start Marketing Date: [9]
    01-15-2014
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 64108-313-01

    Package Description: 20 mL in 1 BOTTLE

    NDC Code 64108-313-06

    Package Description: 6 BOTTLE in 1 PACKAGE / 20 mL in 1 BOTTLE (64108-313-01)

    NDC Code 64108-313-24

    Package Description: 24 BOTTLE in 1 PACKAGE / 20 mL in 1 BOTTLE (64108-313-01)

    NDC Code 64108-313-60

    Package Description: 60 BOTTLE in 1 PACKAGE / 20 mL in 1 BOTTLE (64108-313-01)

    Product Details

    What is NDC 64108-313?

    The NDC code 64108-313 is assigned by the FDA to the product Ocufresh which is a human over the counter drug product labeled by Optics Laboratory Inc.. The generic name of Ocufresh is water. The product's dosage form is liquid and is administered via ophthalmic form. The product is distributed in 4 packages with assigned NDC codes 64108-313-01 20 ml in 1 bottle , 64108-313-06 6 bottle in 1 package / 20 ml in 1 bottle (64108-313-01), 64108-313-24 24 bottle in 1 package / 20 ml in 1 bottle (64108-313-01), 64108-313-60 60 bottle in 1 package / 20 ml in 1 bottle (64108-313-01). 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 Ocufresh?

    Do not dilute solution or reuse bottlehold container a few inches above the eyecontrol rate of flow by pressure on bottleflush affected area as neededWithout Cuphold container a few inches above the eyecontrol rate of flow by pressure on bottleflush affected area as neededWith Cuprinse cup with clean water immediately before each use. Avoid contamination of rim and inside surfaceof cupfill cup half full with OcuFresh Eye Wash and apply the cup to the affected eye , pressing tightly to prevent escape of the liquid, and tilt the head backwardopen eyelids wide and rotate eyeball to ensure thorough bathing with the washrinse cup with clean water after each use

    What are Ocufresh 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.
    • WATER .988 mL/mL - A clear, odorless, tasteless liquid that is essential for most animal and plant life and is an excellent solvent for many substances. The chemical formula is hydrogen oxide (H2O). (McGraw-Hill Dictionary of Scientific and Technical Terms, 4th ed)

    Which are Ocufresh UNII Codes?

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

    Which are Ocufresh 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 Ocufresh?

    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:

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    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".