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  5. NDC Package Code: 0031-9307-01 Robitussin Medi-soothers

NDC Package 0031-9307-01 Robitussin Medi-soothers

Dextromethorphan Hydrobromide,Menthol Lozenge Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
0031-9307-01
Package Description:
16 LOZENGE in 1 BLISTER PACK
Product Code:
0031-9307
Proprietary Name:
Robitussin Medi-soothers
Non-Proprietary Name:
Dextromethorphan Hydrobromide, Menthol
Substance Name:
Dextromethorphan Hydrobromide; Menthol, Unspecified Form
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
11-Digit NDC Billing Format:
00031930701
NDC to RxNorm Crosswalk:
  • RxCUI: 1301246 - dextromethorphan HBr 5 MG / menthol 5 MG Oral Lozenge
  • RxCUI: 1301246 - dextromethorphan hydrobromide 5 MG / menthol 5 MG Oral Lozenge
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Haleon Us Holdings Llc
    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(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • DEXTROMETHORPHAN HYDROBROMIDE 5 mg/1
  • MENTHOL, UNSPECIFIED FORM 5 mg/1
    • Pharmacologic Class(es):
  • Sigma-1 Agonist - [EPC] (Established Pharmacologic Class)
  • Sigma-1 Receptor Agonists - [MoA] (Mechanism of Action)
  • Uncompetitive N-methyl-D-aspartate Receptor Antagonist - [EPC] (Established Pharmacologic Class)
  • Uncompetitive NMDA Receptor Antagonists - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    M012
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    06-01-2023
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 0031-9307-01?

    The NDC Packaged Code 0031-9307-01 is assigned to a package of 16 lozenge in 1 blister pack of Robitussin Medi-soothers, a human over the counter drug labeled by Haleon Us Holdings Llc. The product's dosage form is lozenge and is administered via oral form.

    Is NDC 0031-9307 included in the NDC Directory?

    Yes, Robitussin Medi-soothers with product code 0031-9307 is active and included in the NDC Directory. The product was first marketed by Haleon Us Holdings Llc on June 01, 2023 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 0031-9307-01?

    The 11-digit format is 00031930701. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    4-4-20031-9307-015-4-200031-9307-01