Dextromethorphan Hbr,guaifenesin Capsule, Liquid Filled
NDC Package 35916-0760-1

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Dextromethorphan Hbr, Guaifenesin capsules is useshelps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productivetemporarily relieves:cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritantsthe intensity of coughingthe impulse to cough to help you get to sleep. This formulation utilizes a capsule, liquid filled delivery system. Marketed by Softgel Healthcare Private Limited, this product is identified by NDC 35916-0760 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
35916-0760-1
Package Description
1000 CAPSULE, LIQUID FILLED in 1 BAG
Product Code
35916-0760
11-Digit Billing Format
35916076001
RxNorm Crosswalk
  • RxCUI: 1111663 - dextromethorphan HBr 10 MG / guaiFENesin 200 MG Oral Capsule
  • RxCUI: 1111663 - dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG Oral Capsule

Clinical Specifications

Proprietary Name
Dextromethorphan Hbr, Guaifenesin
Non-Proprietary Name
Dextromethorphan Hbr, Guaifenesin
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.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Useshelps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productivetemporarily relieves:cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritantsthe intensity of coughingthe impulse to cough to help you get to sleep

Regulatory & Marketing

Labeler Name
Softgel Healthcare Private Limited
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
03-21-2025
Listing Expiration
12-31-2027
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 35916-0760-1 identifies a specific commercial package of 1000 capsule, liquid filled in 1 bag of Dextromethorphan Hbr, Guaifenesin, a human over the counter drug labeled by Softgel Healthcare Private Limited. 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 Private Limited on March 21, 2025. The current certification is valid through December 31, 2027.

How is this Softgel Healthcare Private Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 35916076001. 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)
35916-0760-1
11-Digit CMS (5-4-2)
35916-0760-01

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