Mineral Oil
NDC Package 36800-334-16

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

Package Information

Mineral Oil oils is mineral oil is used to treat constipation. This formulation utilizes a oil delivery system. Marketed by Top Care (topco Associates Llc), this product is identified by NDC 36800-334 and is authorized under FDA application M007.

Identification & Billing

NDC Package Code
36800-334-16
Package Description
473 mL in 1 BOTTLE, PLASTIC
Product Code
36800-334
11-Digit Billing Format
36800033416

Clinical Specifications

Proprietary Name
Mineral Oil
Non-Proprietary Name
Mineral Oil
Substance Name
Mineral Oil
Dosage Form
Oil - An unctuous, combustible substance which is liquid, or easily liquefiable, on warming, and is soluble in ether but insoluble in water. Such substances, depending on their origin, are classified as animal, mineral, or vegetable oils.
Administration Route
  • Oral - Administration to or by way of the mouth.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
MINERAL OIL 100 mg/100mL
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
Top Care (topco Associates Llc)
Product Type
Human Otc Drug
FDA Application #
M007
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
11-30-2016
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 36800-334-16 identifies a specific commercial package of 473 ml in 1 bottle, plastic of Mineral Oil, a human over the counter drug labeled by Top Care (topco Associates Llc). This oil is formulated for oral; topical 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 Top Care (topco Associates Llc) on November 30, 2016. 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 Top Care (topco Associates Llc) product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 36800033416. 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)
36800-334-16
11-Digit CMS (5-4-2)
36800-0334-16

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