Mineral Oil
NDC Package 21695-681-07

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Mineral Oil is used to treat constipation. Marketed by Rebel Distributors Corp, this product is identified by NDC 21695-681 and is authorized under FDA application part346.

Identification & Billing

NDC Package Code
21695-681-07
Package Description
7 g in 1 TUBE
Product Code
21695-681
11-Digit Billing Format
21695068107
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
7 GM
RxNorm Crosswalk
  • RxCUI: 701984 - mineral oil 42.5 % / petrolatum 56.8 % Ophthalmic Ointment
  • RxCUI: 701984 - mineral oil 0.425 MG/MG / petrolatum 0.568 MG/MG Ophthalmic Ointment
  • RxCUI: 701984 - mineral oil 42.5 % / petrolatum, white 56.8 % Ophthalmic Ointment

Clinical Specifications

Proprietary Name
Mineral Oil
Dosage Form
-
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
Rebel Distributors Corp
FDA Application #
part346
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
11-30-2007
Listing Expiration
12-31-2017
Exclude Flag
I
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (21695-681). Click a package code to view its specific billing and regulatory data.

21695-681-35
3.5 g in 1 TUBE

* 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 21695-681-07 identifies a specific commercial package of 7 g in 1 tube of Mineral Oil, labeled by Rebel Distributors Corp. This product is billed per "GM" gram and contains an estimated amount of 7 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Rebel Distributors Corp on November 30, 2007. The current certification is valid through December 31, 2017.

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 Rebel Distributors Corp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 21695068107. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 7 total billable units per package. 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)
21695-681-07
11-Digit CMS (5-4-2)
21695-0681-07

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