Mineral Oil Lubricant Laxative
NDC Package 49348-006-11

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. 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 Lubricant Laxative is single daily doseadults & children 12 years and over1 bottle once dailychildren 2 to under12 years1/2 bottle once dailychildren under2 yearsdo not useHow to use this enema:REMOVE GREEN PROTECTIVE SHIELD BEFORE INSERTING; HOLD BOTTLE UPRIGHT, GRASPING BOTTLE CAP WITH FINGERS. Marketed by Mckesson, this product is identified by NDC 49348-006 and is authorized under FDA application part334.

Identification & Billing

NDC Package Code
49348-006-11
Package Description
1 BOTTLE in 1 BOX / 133 mL in 1 BOTTLE
Product Code
49348-006
11-Digit Billing Format
49348000611
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Mineral Oil Lubricant Laxative
Dosage Form
-
Usage Information
Single daily doseadults & children 12 years and over1 bottle once dailychildren 2 to under12 years1/2 bottle once dailychildren under2 yearsdo not useHow to use this enema:REMOVE GREEN PROTECTIVE SHIELD BEFORE INSERTING; HOLD BOTTLE UPRIGHT, GRASPING BOTTLE CAP WITH FINGERS. GRASP PROTECTIVE SHIELD WITH OTHER HAND AND PULL GENTLY TO REMOVE.Positioning:Left-side position: Lie on left side with knee bent and arms at rest.Knee-chest position:Kneel, then lower head and chest forward until left side of face is resting on surface. Position arms comfortably.Administering enema:With steady pressure, gently insert enema tip into rectum with a slight side-to-side movement, with tip pointing toward navel. Insertion may be easier if person receiving enema bears down, as if having a bowel movement. This helps relax the muscles around the anus.Do not force the enema tip into rectum as this can cause injury.Squeeze bottle until nearly all liquid is gone. It is not necessary to empty the bottle completely, as it contains more liquid than needed. Remove enema tip from rectum.Retain enema in accordance with doctor's instructions.

Regulatory & Marketing

Labeler Name
Mckesson
FDA Application #
part334
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
07-16-2012
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 49348-006-11 identifies a specific commercial package of 1 bottle in 1 box / 133 ml in 1 bottle of Mineral Oil Lubricant Laxative, labeled by Mckesson. 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 Mckesson on July 16, 2012. The current certification is valid through December 31, 2017.

How is this Mckesson product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49348000611. 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)
49348-006-11
11-Digit CMS (5-4-2)
49348-0006-11

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