Robitussin Medi-soothers Lozenge
NDC Package 0031-9307-01

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

Package Information

Robitussin Medi-soothers (dextromethorphan hydrobromide, menthol) lozenges is ▪adults and children 12 years of age and older: take 2 lozenges (one immediately after the other) every 4 hours as needed. This formulation utilizes a lozenge delivery system. Marketed by Haleon Us Holdings Llc, this product is identified by NDC 0031-9307 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
0031-9307-01
Package Description
16 LOZENGE in 1 BLISTER PACK
Product Code
0031-9307
11-Digit Billing Format
00031930701
RxNorm Crosswalk
  • RxCUI: 1301246 - dextromethorphan HBr 5 MG / menthol 5 MG Oral Lozenge
  • RxCUI: 1301246 - dextromethorphan hydrobromide 5 MG / menthol 5 MG Oral Lozenge

Clinical Specifications

Proprietary Name
Robitussin Medi-soothers
Non-Proprietary Name
Dextromethorphan Hydrobromide, Menthol
Substance Name
Dextromethorphan Hydrobromide; Menthol, Unspecified Form
Dosage Form
Lozenge - A solid preparation containing one or more medicaments, usually in a flavored, sweetened base which is intended to dissolve or disintegrate slowly in the mouth. A lollipop is a lozenge on a stick.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
▪adults and children 12 years of age and older: take 2 lozenges (one immediately after the other) every 4 hours as needed. Allow each lozenge to dissolve slowly in the mouth.▪do not take more than 12 lozenges in any 24-hour period, or as directed by a doctor▪children under 12 years of age: do not use

Regulatory & Marketing

Labeler Name
Haleon Us Holdings Llc
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-01-2023
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 0031-9307-01 identifies a specific commercial package of 16 lozenge in 1 blister pack of Robitussin Medi-soothers, a human over the counter drug labeled by Haleon Us Holdings Llc. This lozenge is formulated for oral use and contains dextromethorphan hydrobromide; menthol, unspecified form 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 June 01, 2023. 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: 00031930701. 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)
0031-9307-01
11-Digit CMS (5-4-2)
00031-9307-01

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