Np Enema Non Penetrating Safety Tip Saline Liquid
NDC Package 85931-018-00

11-digit billing NDC: 85931001800
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Np Enema Non Penetrating Safety Tip Saline (sodium phosphate, monobasic, unspecified form, sodium phosphate, dibasic, unspecified form) liquids is single Daily Dosage (per 24h) Do not use if taking another sodium phosphate product. This formulation utilizes a liquid delivery system. Marketed by Sterilab, Inc., this product is identified by NDC 85931-018 and is authorized under FDA application M007.

Identification & Billing

NDC Package Code
85931-018-00
Package Description
1 BOTTLE, WITH APPLICATOR in 1 BOX / 133 mL in 1 BOTTLE, WITH APPLICATOR
Product Code
85931-018
11-Digit Billing Format
85931001800

Clinical Specifications

Proprietary Name
Np Enema Non Penetrating Safety Tip Saline
Non-Proprietary Name
Sodium Phosphate, Monobasic, Unspecified Form, Sodium Phosphate, Dibasic, Unspecified Form
Substance Name
Sodium Phosphate, Monobasic, Unspecified Form; Sodium Phosphate, Dibasic, Unspecified Form
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route
Rectal - Administration to the rectum.
Active Ingredient(s)
Usage Information
Single Daily Dosage (per 24h) Do not use if taking another sodium phosphate product. Do not use more unless directed by a doctor. See Warnings.  Adults and children 12 years and over 1 bottle per day Children 2 to 11 years Ask a doctor Children under 2 years DO NOT USEIf urge is felt after 5 minutes of using, try to empty bowel. Call a doctor promptly if no liquid comes out of the rectum after 30 minutes because dehydration could occur.

Regulatory & Marketing

Labeler Name
Sterilab, Inc.
Product Type
Human Otc Drug
FDA Application #
M007
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
09-15-2026
Listing Expiration
12-31-2027
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 85931-018-00 identifies a specific commercial package of 1 bottle, with applicator in 1 box / 133 ml in 1 bottle, with applicator of Np Enema Non Penetrating Safety Tip Saline, a human over the counter drug labeled by Sterilab, Inc.. This liquid is formulated for rectal use and contains sodium phosphate, monobasic, unspecified form; sodium phosphate, dibasic, unspecified form 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 Sterilab, Inc. on September 15, 2026. The current certification is valid through December 31, 2027.

How is this Sterilab, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 85931001800. 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)
85931-018-00
11-Digit CMS (5-4-2)
85931-0018-00

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