1. Home
  2. Labeler Index
  3. Medline Industries, Lp
  4. 53329-014
  5. NDC Package Code: 53329-014-11 Pure And Gentle Laxative

NDC Package 53329-014-11 Pure And Gentle Laxative

Sodium Phosphate Enema Rectal - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
53329-014-11
Package Description:
1 BOTTLE in 1 BOX / 133 mL in 1 BOTTLE
Product Code:
53329-014
Proprietary Name:
Pure And Gentle Laxative
Non-Proprietary Name:
Sodium Phosphate
Substance Name:
Sodium Phosphate, Dibasic; Sodium Phosphate, Monobasic
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.
11-Digit NDC Billing Format:
53329001411
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to 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
Product Type:
Human Otc Drug
Labeler Name:
Medline Industries, Lp
Dosage Form:
Enema - A rectal preparation for therapeutic, diagnostic, or nutritive purposes.
Administration Route(s):
Rectal - Administration to the rectum.
Active Ingredient(s):
Sample Package:
No
FDA Application Number:
M007
Marketing Category:
OTC MONOGRAPH DRUG -
Start Marketing Date:
04-09-2014
Listing Expiration Date:
12-31-2025
Exclude Flag:
N
Code Structure:

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 disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package CodePackage Description
53329-014-5824 BOTTLE in 1 CASE / 133 mL in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 53329-014-11?

The NDC Packaged Code 53329-014-11 is assigned to a package of 1 bottle in 1 box / 133 ml in 1 bottle of Pure And Gentle Laxative, a human over the counter drug labeled by Medline Industries, Lp. The product's dosage form is enema and is administered via rectal form.

Is NDC 53329-014 included in the NDC Directory?

Yes, Pure And Gentle Laxative with product code 53329-014 is active and included in the NDC Directory. The product was first marketed by Medline Industries, Lp on April 09, 2014 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 53329-014-11?

The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

What is the 11-digit format for NDC 53329-014-11?

The 11-digit format is 53329001411. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-253329-014-115-4-253329-0014-11