Mineral Oil Solution
NDC Package 81033-042-50

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

Package Information

Mineral Oil solution is mineral oil is used to treat constipation. This formulation utilizes a solution delivery system. Marketed by Kesin Pharma Corporation, this product is identified by NDC 81033-042 and is authorized under FDA application M007.

Identification & Billing

NDC Package Code
81033-042-50
Package Description
50 CUP, UNIT-DOSE in 1 CARTON / 30 mL in 1 CUP, UNIT-DOSE (81033-042-30)
Product Code
81033-042
11-Digit Billing Format
81033004250
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Mineral Oil
Non-Proprietary Name
Mineral Oil
Substance Name
Mineral Oil
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
MINERAL OIL 1000 mg/mL
Usage Information
Mineral oil is used to treat constipation. It is known as a lubricant laxative. It works by keeping water in the stool and intestines. This helps to soften the stool and also makes it easier for stool to pass through the intestines. This medication should not be used in older adults, children younger than 6 years, or in people who are bedridden.

Regulatory & Marketing

Labeler Name
Kesin Pharma Corporation
Product Type
Human Otc Drug
FDA Application #
M007
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
03-01-2025
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 81033-042-50 identifies a specific commercial package of 50 cup, unit-dose in 1 carton / 30 ml in 1 cup, unit-dose (81033-042-30) of Mineral Oil, a human over the counter drug labeled by Kesin Pharma Corporation. This solution is formulated for oral use and contains mineral oil 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 Kesin Pharma Corporation on March 01, 2025. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Mineral oil is used to treat constipation. It is known as a lubricant laxative. It works by keeping water in the stool and intestines. This helps to soften the stool and also makes it easier for stool to pass through the intestines. This medication should not be used in older adults, children younger than 6 years, or in people who are bedridden.

How is this Kesin Pharma Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 81033004250. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
81033-042-50
11-Digit CMS (5-4-2)
81033-0042-50

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