robitussin medi-soothers

Generic: dextromethorphan hydrobromide, menthol

Labeler: haleon us holdings llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name robitussin medi-soothers
Generic Name dextromethorphan hydrobromide, menthol
Labeler haleon us holdings llc
Dosage Form LOZENGE
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 5 mg/1, menthol, unspecified form 5 mg/1

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0031-9307
Product ID 0031-9307_1571df1a-4352-e93d-e063-6294a90a576a
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2023-06-01

Pharmacologic Class

Classes
sigma-1 agonist [epc] sigma-1 receptor agonists [moa] uncompetitive n-methyl-d-aspartate receptor antagonist [epc] uncompetitive nmda receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00319307
Hyphenated Format 0031-9307

Supplemental Identifiers

RxCUI
1301246
UNII
9D2RTI9KYH L7T10EIP3A

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name robitussin medi-soothers (source: ndc)
Generic Name dextromethorphan hydrobromide, menthol (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 16 LOZENGE in 1 BLISTER PACK (0031-9307-01)
source: ndc

Packages (1)

0031-9307-01 16 LOZENGE in 1 BLISTER PACK (0031-9307-01)

Ingredients (2)

dextromethorphan hydrobromide (5 mg/1) menthol, unspecified form (5 mg/1)

Linked Drug Pages (1)

Robitussin Medi-Soothers ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1571df1a-4352-e93d-e063-6294a90a576a", "openfda": {"unii": ["9D2RTI9KYH", "L7T10EIP3A"], "rxcui": ["1301246"], "spl_set_id": ["4c3d57e3-e40b-41ca-b44b-5f4c5f4dbae5"], "manufacturer_name": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "16 LOZENGE in 1 BLISTER PACK (0031-9307-01)", "package_ndc": "0031-9307-01", "marketing_start_date": "20230601"}], "brand_name": "Robitussin Medi-Soothers", "product_id": "0031-9307_1571df1a-4352-e93d-e063-6294a90a576a", "dosage_form": "LOZENGE", "pharm_class": ["Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]"], "product_ndc": "0031-9307", "generic_name": "dextromethorphan hydrobromide, menthol", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Robitussin Medi-Soothers", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "5 mg/1"}, {"name": "MENTHOL, UNSPECIFIED FORM", "strength": "5 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20230601", "listing_expiration_date": "20261231"}