Reflief Saline Laxative Pediatric Ready To Use Enema
NDC Package 69626-0085-7

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

Package Information

Reflief Saline Laxative Pediatric Ready To Use (sodium phosphate, dibasic, unspecified form and sodium phosphate, monobasic, unspecified form) enemas is single daily dosage (per 24 hours)Do not use if taking another sodium phosphate product.Do not use more unless directed by a doctor. This formulation utilizes a enema delivery system. Marketed by Leosons Overseas Corp, this product is identified by NDC 69626-0085 and is authorized under FDA application M007.

Identification & Billing

NDC Package Code
69626-0085-7
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 67 mL in 1 BOTTLE, PLASTIC
Product Code
69626-0085
11-Digit Billing Format
69626008507
RxNorm Crosswalk
  • RxCUI: 283100 - sodium phosphate, dibasic 7 GM / sodium phosphate, monobasic 19 GM in 118 ML Enema
  • RxCUI: 283100 - sodium phosphate, dibasic 59.3 MG/ML / sodium phosphate, monobasic 161 MG/ML Enema
  • RxCUI: 283100 - sodium phosphate, dibasic 3.5 GM / sodium phosphate, monobasic 9.5 GM per 59 ML Enema
  • RxCUI: 283100 - sodium phosphate, dibasic 7 GM / sodium phosphate, monobasic 19 GM per 118 ML Enema

Clinical Specifications

Proprietary Name
Reflief Saline Laxative Pediatric Ready To Use
Non-Proprietary Name
Sodium Phosphate, Dibasic, Unspecified Form And Sodium Phosphate, Monobasic, Unspecified Form
Substance Name
Sodium Phosphate, Dibasic, Unspecified Form; Sodium Phosphate, Monobasic, Unspecified Form
Dosage Form
Enema - A rectal preparation for therapeutic, diagnostic, or nutritive purposes.
Administration Route
Rectal - Administration to the rectum.
Active Ingredient(s)
Usage Information
Single daily dosage (per 24 hours)Do not use if taking another sodium phosphate product.Do not use more unless directed by a doctor. See Warnings.children 2 to under 12 years of ageUse 1 bottle once dailychildren under 2 years of ageDO NOT USE

Regulatory & Marketing

Labeler Name
Leosons Overseas Corp
Product Type
Human Otc Drug
FDA Application #
M007
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
10-01-2019
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 69626-0085-7 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 67 ml in 1 bottle, plastic of Reflief Saline Laxative Pediatric Ready To Use, a human over the counter drug labeled by Leosons Overseas Corp. This enema is formulated for rectal use and contains sodium phosphate, dibasic, unspecified form; sodium phosphate, monobasic, 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 Leosons Overseas Corp on October 01, 2019. The current certification is valid through December 31, 2026.

How is this Leosons Overseas Corp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69626008507. 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 (5-4-1)
69626-0085-7
11-Digit CMS (5-4-2)
69626-0085-07

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