Dyna-hex Liquid
NDC Package 0116-1021-17

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

Dyna-hex (chlorhexidine gluconate) liquids is a medication used along with regular tooth brushing/flossing to treat gingivitis, a gum disease that causes red, swollen, and easily bleeding gums. This formulation utilizes a liquid delivery system. Marketed by Xttrium Laboratories, Inc., this product is identified by NDC 0116-1021 and is authorized under FDA application NDA019422.

Identification & Billing

NDC Package Code
0116-1021-17
Package Description
473 mL in 1 BOTTLE, PLASTIC
Product Code
0116-1021
11-Digit Billing Format
00116102117
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
473 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Dyna-hex 2
Non-Proprietary Name
Chlorhexidine Gluconate
Substance Name
Chlorhexidine Gluconate
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
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
Pharmacologic Class
Usage Information
This medication is used along with regular tooth brushing/flossing to treat gingivitis, a gum disease that causes red, swollen, and easily bleeding gums. Chlorhexidine belongs to a class of drugs known as antimicrobials. It works by decreasing the amount of bacteria in the mouth, helping to reduce swelling and redness of the gums and bleeding when you brush.

Regulatory & Marketing

Labeler Name
Xttrium Laboratories, Inc.
Product Type
Human Otc Drug
FDA Application #
NDA019422
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-01-2014
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 (0116-1021). Click a package code to view its specific billing and regulatory data.

0116-1021-01
15142 mL in 1 JUG
0116-1021-04
118 mL in 1 BOTTLE, PLASTIC
0116-1021-08
237 mL in 1 BOTTLE, PLASTIC
0116-1021-16
473 mL in 1 BOTTLE, PLASTIC
0116-1021-32
946 mL in 1 BOTTLE, PLASTIC
0116-1021-85
250 mL in 1 BOTTLE, PUMP

* 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 0116-1021-17 identifies a specific commercial package of 473 ml in 1 bottle, plastic of Dyna-hex 2, a human over the counter drug labeled by Xttrium Laboratories, Inc.. This liquid is formulated for topical use and contains chlorhexidine gluconate 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 Xttrium Laboratories, Inc. on January 01, 2014. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used along with regular tooth brushing/flossing to treat gingivitis, a gum disease that causes red, swollen, and easily bleeding gums. Chlorhexidine belongs to a class of drugs known as antimicrobials. It works by decreasing the amount of bacteria in the mouth, helping to reduce swelling and redness of the gums and bleeding when you brush.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00116102117. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 473 total billable units per package. 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 (4-4-2)
0116-1021-17
11-Digit CMS (5-4-2)
00116-1021-17

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