4718 Enema, Mineral Oil Enema
NDC Package 67777-430-01

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

Package Information

4718 Enema, Mineral Oil enemas is mineral oil is used to treat constipation. This formulation utilizes a enema delivery system. Marketed by Dynarex, this product is identified by NDC 67777-430 and is authorized under FDA application M007.

Identification & Billing

NDC Package Code
67777-430-01
Package Description
48 BOX in 1 CASE / 1 BOTTLE in 1 BOX (67777-430-02) / 133 mL in 1 BOTTLE
Product Code
67777-430
11-Digit Billing Format
67777043001
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
4718 Enema, Mineral Oil
Non-Proprietary Name
4718 Enema, Mineral Oil
Substance Name
Mineral Oil
Dosage Form
Enema - A rectal preparation for therapeutic, diagnostic, or nutritive purposes.
Administration Route
Rectal - Administration to the rectum.
Active Ingredient(s)
MINERAL OIL 133 g/133mL
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
Dynarex
Product Type
Human Otc Drug
FDA Application #
M007
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
02-26-2021
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 67777-430-01 identifies a specific commercial package of 48 box in 1 case / 1 bottle in 1 box (67777-430-02) / 133 ml in 1 bottle of 4718 Enema, Mineral Oil, a human over the counter drug labeled by Dynarex. This enema is formulated for rectal 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 Dynarex on February 26, 2021. 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 Dynarex product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67777043001. 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)
67777-430-01
11-Digit CMS (5-4-2)
67777-0430-01

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