Pure And Gentle Laxative Enema
NDC Package 53329-014-58

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

Package Information

Pure And Gentle Laxative (sodium phosphate) enemas is (or as directed by a doctor)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 Medline Industries, Lp, this product is identified by NDC 53329-014 and is authorized under FDA application M007.

Identification & Billing

NDC Package Code
53329-014-58
Package Description
24 BOTTLE in 1 CASE / 133 mL in 1 BOTTLE
Product Code
53329-014
11-Digit Billing Format
53329001458
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
Pure And Gentle Laxative
Non-Proprietary Name
Sodium Phosphate
Substance Name
Sodium Phosphate, Dibasic; Sodium Phosphate, Monobasic
Dosage Form
Enema - A rectal preparation for therapeutic, diagnostic, or nutritive purposes.
Administration Route
Rectal - Administration to the rectum.
Active Ingredient(s)
Usage Information
(or as directed by a doctor)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.adults & children12 years and over1 bottle once dailychildren 2 to under12 yearsUse Pediatric Enemachildren under2 yearsDO NOT USECAUTION:Remove protective shield from enema tip before inserting.Hold bottle upright, grasping bottle cap with fingers. Grasp protective shield with other hand and pull gently to remove.Positions for using this enema: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 with left arm folded 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. Doing so helps relax muscles around anus.Do not force enema tip into rectum. Stop using if tip is hard to insert. Forcing the tip into the rectum can cause injury (especially if you have hemorrhoids). If enema tip causes rectal bleeding or pain, get immediate medical care.Squeeze bottle until nearly all liquid is gone. It is not necessary to empty unit completely, as it containsmore liquid than needed.Remove tip from rectum and stay in position until urge to evacuate is strong (usually 1 to 5 minutes). If no 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. (or as directed by a doctor)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 WarningsAdults and children 12 years old and older1 bottle once dailyChildren 2 to under 12 years oldUse Pediatric EnemaChildren under 2 yearsDO NOT USECAUTION: Remove protective shield from enema tip before inserting.Hold bottle upright, grasping bottle cap with fingers. Grasp protective shield with other hand and pull gently to remove.Positions for using this enema:Left-side position: Lie on left side with knees bent and arms resting comfortably. Knee-chest position: Kneel, then lower head and chest forward until left side of face is resting on surface with left arm folded 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. Doing so helps relax muscles around anus.Do not force enema tip into rectum. Stop using if tip is hard to insert. Forcing the tip into the rectum can cause injury (especially if you have hemorrhoids). If enema tip causes rectal bleeding or pain, get immediate medical care.Squeeze bottle until nearly all liquid is gone. It is not necessary to empty bottle completely, as it contains more liquid than needed.Remove tip from rectum and stay in position until urge to evacuate is strong (usually 1 to 5 minutes). If no 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
Medline Industries, Lp
Product Type
Human Otc Drug
FDA Application #
M007
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-09-2014
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (53329-014). Click a package code to view its specific billing and regulatory data.

53329-014-11
1 BOTTLE in 1 BOX / 133 mL in 1 BOTTLE

* 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 53329-014-58 identifies a specific commercial package of 24 bottle in 1 case / 133 ml in 1 bottle of Pure And Gentle Laxative, a human over the counter drug labeled by Medline Industries, Lp. This enema is formulated for rectal use and contains sodium phosphate, dibasic; sodium phosphate, monobasic 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 Medline Industries, Lp on April 09, 2014. The current certification is valid through December 31, 2026.

How is this Medline Industries, Lp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53329001458. 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)
53329-014-58
11-Digit CMS (5-4-2)
53329-0014-58

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