Oftal-mycin Lubricant Ophthalmic Ointment
NDC Package 48201-301-11

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Oftal-mycin Lubricant Ophthalmic (light mineral, white petrolatum) ointment is for the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sunmay be used as a protectant against further irritation. This formulation utilizes a ointment delivery system. Marketed by Grandall Distributing, Llc, this product is identified by NDC 48201-301 and is authorized under FDA application M014.

Identification & Billing

NDC Package Code
48201-301-11
Package Description
3.5 g in 1 BOTTLE
Product Code
48201-301
11-Digit Billing Format
48201030111
RxNorm Crosswalk
  • RxCUI: 746083 - mineral oil 15 % / petrolatum 83 % Ophthalmic Ointment
  • RxCUI: 746083 - mineral oil 0.15 MG/MG / petrolatum 0.83 MG/MG Ophthalmic Ointment
  • RxCUI: 746083 - mineral oil 15 % / petrolatum, white 83 % Ophthalmic Ointment

Clinical Specifications

Proprietary Name
Oftal-mycin Lubricant Ophthalmic
Non-Proprietary Name
Light Mineral, White Petrolatum
Substance Name
Light Mineral Oil; White Petrolatum
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
Ophthalmic - Administration to the external eye.
Active Ingredient(s)
Usage Information
For the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sunmay be used as a protectant against further irritation

Regulatory & Marketing

Labeler Name
Grandall Distributing, Llc
Product Type
Human Otc Drug
FDA Application #
M014
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
12-18-2024
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 48201-301-11 identifies a specific commercial package of 3.5 g in 1 bottle of Oftal-mycin Lubricant Ophthalmic, a human over the counter drug labeled by Grandall Distributing, Llc. This ointment is formulated for ophthalmic use and contains light mineral oil; white petrolatum as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Grandall Distributing, Llc on December 18, 2024. The current certification is valid through December 31, 2026.

How is this Grandall Distributing, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 48201030111. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
48201-301-11
11-Digit CMS (5-4-2)
48201-0301-11

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.