NDC 0023-0312-04 Refresh Lacri-lube

Mineral Oil, Petrolatum

NDC Package Code 0023-0312-04

The NDC Code 0023-0312-04 is assigned to a package of 1 tube in 1 carton > 3.5 g in 1 tube of Refresh Lacri-lube, a human over the counter drug labeled by Allergan, Inc.. The product's dosage form is ointment and is administered via ophthalmic form.

Field Name Field Value
NDC Code 0023-0312-04
Package Description 1 TUBE in 1 CARTON > 3.5 g in 1 TUBE
Proprietary Name Refresh Lacri-lube 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 Mineral Oil, Petrolatum 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.
11-Digit NDC Billing Format 00023031204 NDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.
Billing Unit GM - Billing unit of "gram" is used when a product is measured by its weight.
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.
Labeler Name Allergan, Inc.
Dosage Form Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route(s)
  • Ophthalmic - Administration to the external eye.
Active Ingredient(s)
  • MINERAL OIL 425 mg/g
  • PETROLATUM 568 mg/g
Sample Package No Sample Package?
This field Indicates whether this package is a sample packaging or not.
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.
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.
Start Marketing Date 12-15-1977 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’.

NDC Code Structure

  • 0023 - Allergan, Inc.
    • 0023-0312 - Refresh Lacri-lube
      • 0023-0312-04 - 1 TUBE in 1 CARTON

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the disclaimer below.

Other Product Packages

The following packages are also available for Refresh Lacri-lube with product NDC 0023-0312.

NDC Package CodePackage Description
0023-0312-071 TUBE in 1 CARTON > 7 g in 1 TUBE

* Please review the disclaimer below.