Mineral Oil
NDC Package 49035-035-16

11-digit billing NDC: 49035003516 · Billing unit: ML · 473 ML per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Mineral Oil oils is do not take with mealstake only at bedtimemay be taken as a single daily dose or in divided dosesadults and children 12 years of age and over: oral dosage is a minimal single dose of 15 mL to a maximum daily dose of 45 mLchildren 6 to under 12 years of age: oral dosage is a minimum single dose of 5 mL to a maximum daily dose of 15 mLChildren under 6 years, consult a doctor. This formulation utilizes a oil delivery system. Marketed by Equate (wal-mart Stores, Inc.) (see Also Wal-mart Inc), this product is identified by NDC 49035-035 and is authorized under FDA application M007.

Identification & Billing

NDC Package Code
49035-035-16
Package Description
473 mL in 1 BOTTLE
Product Code
49035-035
11-Digit Billing Format
49035003516
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
473 ML

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.
Active Ingredient(s)
MINERAL OIL 100 mg/100mL
Usage Information
Do not take with mealstake only at bedtimemay be taken as a single daily dose or in divided dosesadults and children 12 years of age and over: oral dosage is a minimal single dose of 15 mL to a maximum daily dose of 45 mLchildren 6 to under 12 years of age: oral dosage is a minimum single dose of 5 mL to a maximum daily dose of 15 mLChildren under 6 years, consult a doctor

Regulatory & Marketing

Labeler Name
Equate (wal-mart Stores, Inc.) (see Also Wal-mart Inc)
Product Type
Human Otc Drug
FDA Application #
M007
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
10-31-2014
End Marketing Date
08-28-2027
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 49035-035-16 identifies a specific commercial package of 473 ml in 1 bottle of Mineral Oil, a human over the counter drug labeled by Equate (wal-mart Stores, Inc.) (see Also Wal-mart Inc). This product is billed per "ML" milliliter and contains an estimated amount of 473 billable units per package. This oil 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 Equate (wal-mart Stores, Inc.) (see Also Wal-mart Inc) on October 31, 2014.

How is this Equate (wal-mart Stores, Inc.) (see Also Wal-mart Inc) product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49035003516. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 473 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)
49035-035-16
11-Digit CMS (5-4-2)
49035-0035-16

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