Robitussin Direct Cough Capsule, Liquid Filled
NDC Package 0031-9302-01

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

Package Information

Robitussin Direct Cough (dextromethorphan hydrobromide) capsules is usetemporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold. This formulation utilizes a capsule, liquid filled delivery system. Marketed by Haleon Us Holdings Llc, this product is identified by NDC 0031-9302 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
0031-9302-01
Package Description
18 CAPSULE, LIQUID FILLED in 1 BOTTLE
Product Code
0031-9302
11-Digit Billing Format
00031930201
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Robitussin Direct Cough
Non-Proprietary Name
Dextromethorphan Hydrobromide
Substance Name
Dextromethorphan Hydrobromide
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)
DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1
Pharmacologic Class
Usage Information
Usetemporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold.

Regulatory & Marketing

Labeler Name
Haleon Us Holdings Llc
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-15-2022
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0031-9302-01 identifies a specific commercial package of 18 capsule, liquid filled in 1 bottle of Robitussin Direct Cough, a human over the counter drug labeled by Haleon Us Holdings Llc. This capsule, liquid filled is formulated for oral use and contains dextromethorphan hydrobromide 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 Haleon Us Holdings Llc on July 15, 2022. The current certification is valid through December 31, 2026.

How is this Haleon Us Holdings Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00031930201. 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)
0031-9302-01
11-Digit CMS (5-4-2)
00031-9302-01

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