Guaifenesin,dextromethorphan Hbr Capsule, Liquid Filled
NDC Package 35916-0759-2

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, Dextromethorphan Hbr capsules is usestemporarily relieves cough due to minor throat and bronchial irritation as may occur with a coldhelps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive. This formulation utilizes a capsule, liquid filled delivery system. Marketed by Softgel Healthcare Pvt Ltd, this product is identified by NDC 35916-0759 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
35916-0759-2
Package Description
2 POUCH in 1 BOX / 3000 CAPSULE, LIQUID FILLED in 1 POUCH
Product Code
35916-0759
11-Digit Billing Format
35916075902
RxNorm Crosswalk
  • RxCUI: 1661740 - dextromethorphan HBr 20 MG / guaiFENesin 400 MG Oral Capsule
  • RxCUI: 1661740 - dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral Capsule

Clinical Specifications

Proprietary Name
Guaifenesin, Dextromethorphan Hbr
Non-Proprietary Name
Guaifenesin, Dextromethorphan Hbr
Substance Name
Dextromethorphan Hydrobromide; Guaifenesin
Dosage Form
Capsule, Liquid Filled - A solid dosage form in which the drug is enclosed within a soluble, gelatin shell which is plasticized by the addition of a polyol, such as sorbitol or glycerin, and is therefore of a somewhat thicker consistency than that of a hard shell capsule; typically, the active ingredients are dissolved or suspended in a liquid vehicle.
Administration Route
  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Usestemporarily relieves cough due to minor throat and bronchial irritation as may occur with a coldhelps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Regulatory & Marketing

Labeler Name
Softgel Healthcare Pvt Ltd
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-11-2025
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 (35916-0759). Click a package code to view its specific billing and regulatory data.

35916-0759-3
2 POUCH in 1 BOX / 2000 CAPSULE, LIQUID FILLED in 1 POUCH
35916-0759-4
2 BAG in 1 BOX / 1500 CAPSULE, LIQUID FILLED in 1 BAG

* 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 35916-0759-2 identifies a specific commercial package of 2 pouch in 1 box / 3000 capsule, liquid filled in 1 pouch of Guaifenesin, Dextromethorphan Hbr, a human over the counter drug labeled by Softgel Healthcare Pvt Ltd. This capsule, liquid filled is formulated for oral use and contains dextromethorphan hydrobromide; 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 Softgel Healthcare Pvt Ltd on July 11, 2025. The current certification is valid through December 31, 2026.

How is this Softgel Healthcare Pvt Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 35916075902. 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 (5-4-1)
35916-0759-2
11-Digit CMS (5-4-2)
35916-0759-02

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