Guaifenesin Dm Syrup
NDC Package 0121-0638-04

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

Guaifenesin Dm (guaifenesin and dextromethorphan) syrups is a medication used as Non-Narcotic, Alcohol Free Expectorant/Cough Suppressant. This formulation utilizes a syrup delivery system. Marketed by Pai Holdings, Llc Dba Pai Pharma, this product is identified by NDC 0121-0638 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
0121-0638-04
Package Description
118 mL in 1 BOTTLE
Product Code
0121-0638
11-Digit Billing Format
00121063804
RxNorm Crosswalk
  • RxCUI: 996520 - dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral Solution
  • RxCUI: 996520 - dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral Solution
  • RxCUI: 996520 - dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral Solution
  • RxCUI: 996520 - dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral Solution
  • RxCUI: 996520 - dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral Solution

Clinical Specifications

Proprietary Name
Guaifenesin Dm
Non-Proprietary Name
Guaifenesin And Dextromethorphan
Substance Name
Dextromethorphan; Guaifenesin
Dosage Form
Syrup - An oral solution containing high concentrations of sucrose or other sugars; the term has also been used to include any other liquid dosage form prepared in a sweet and viscid vehicle, including oral suspensions.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
This product is used as Non-Narcotic, Alcohol Free Expectorant/Cough Suppressant . Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productivetemporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold

Regulatory & Marketing

Labeler Name
Pai Holdings, Llc Dba Pai Pharma
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-01-1992
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 (0121-0638). Click a package code to view its specific billing and regulatory data.

0121-0638-00
10 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0638-05)
0121-0638-08
237 mL in 1 BOTTLE
0121-0638-16
473 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 0121-0638-04 identifies a specific commercial package of 118 ml in 1 bottle of Guaifenesin Dm, a human over the counter drug labeled by Pai Holdings, Llc Dba Pai Pharma. This syrup is formulated for oral use and contains dextromethorphan; guaifenesin 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 Pai Holdings, Llc Dba Pai Pharma on July 01, 1992. The current certification is valid through December 31, 2026.

How is this Pai Holdings, Llc Dba Pai Pharma product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00121063804. 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)
0121-0638-04
11-Digit CMS (5-4-2)
00121-0638-04

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