Foaming Chlorhexidine Gluconate
NDC Package 71788-016-80

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Foaming Chlorhexidine Gluconate is use with care in premature infants under 2 months of age. Marketed by Protect U Guard, Llc, this product is identified by NDC 71788-016 and is authorized under FDA application part349.

Identification & Billing

NDC Package Code
71788-016-80
Package Description
24 BOTTLE, PUMP in 1 CARTON / 100 mL in 1 BOTTLE, PUMP (71788-016-70)
Product Code
71788-016
11-Digit Billing Format
71788001680
RxNorm Crosswalk
  • RxCUI: 211365 - chlorhexidine gluconate 4 % Medicated Liquid Soap
  • RxCUI: 211365 - chlorhexidine gluconate 40 MG/ML Medicated Liquid Soap
  • RxCUI: 211365 - chlorhexidine gluconate 4 % Medicated Surgical Scrub

Clinical Specifications

Proprietary Name
Foaming Chlorhexidine Gluconate
Dosage Form
-
Usage Information
Use with care in premature infants under 2 months of age. These products may cause irritation or chemical burns.skin wound and skin cleansing. Thoroughly rinse the area to be cleansed with water. Apply the minimum amount of the product necessary to cover the skin or wound area and wash gently. Rinse thoroughlysurgical hand scrub. Wet hands and forearms with water. Scrub for 3 minutes with 5mL of the product with brush. Rinse thoroughly under running water. Repeat. Dry thoroughly.healthcare personnel handwash. Wet hands with water. Dispense 5 mL of the product into cupped hands. Wash in a vigorous manner for 15 seconds. Rinse and dry thoroughly.

Regulatory & Marketing

Labeler Name
Protect U Guard, Llc
FDA Application #
part349
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
04-13-2021
Listing Expiration
12-31-2022
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (71788-016). Click a package code to view its specific billing and regulatory data.

71788-016-20
4 BOTTLE, PUMP in 1 CARTON / 1000 mL in 1 BOTTLE, PUMP (71788-016-10)
71788-016-60
12 BOTTLE, PUMP in 1 CARTON / 530 mL in 1 BOTTLE, PUMP (71788-016-50)

* 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 71788-016-80 identifies a specific commercial package of 24 bottle, pump in 1 carton / 100 ml in 1 bottle, pump (71788-016-70) of Foaming Chlorhexidine Gluconate, labeled by Protect U Guard, Llc. 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 Protect U Guard, Llc on April 13, 2021. The current certification is valid through December 31, 2022.

How is this Protect U Guard, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71788001680. 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)
71788-016-80
11-Digit CMS (5-4-2)
71788-0016-80

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