robitussin cough plus chest congestion dm

Generic: dextromethorphan hydrobromide and guaifenesin

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

Drug Facts

Product Profile

Brand Name robitussin cough plus chest congestion dm
Generic Name dextromethorphan hydrobromide and guaifenesin
Labeler haleon us holdings llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 20 mg/20mL, guaifenesin 200 mg/20mL

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0031-8757
Product ID 0031-8757_159a64fb-02c1-1365-e063-6394a90af696
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2018-06-01

Pharmacologic Class

Established (EPC)
expectorant [epc]
Physiologic Effect
decreased respiratory secretion viscosity [pe] increased respiratory secretions [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00318757
Hyphenated Format 0031-8757

Supplemental Identifiers

RxCUI
1790650
UNII
9D2RTI9KYH 495W7451VQ
NUI
N0000193956 N0000008867 N0000009560

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 cough plus chest congestion dm (source: ndc)
Generic Name dextromethorphan hydrobromide and guaifenesin (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/20mL
  • 200 mg/20mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0031-8757-12) / 118 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (0031-8757-18) / 237 mL in 1 BOTTLE
source: ndc

Packages (2)

Ingredients (2)

dextromethorphan hydrobromide (20 mg/20mL) guaifenesin (200 mg/20mL)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "159a64fb-02c1-1365-e063-6394a90af696", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["1790650"], "spl_set_id": ["4908b326-e1da-44ca-8087-7e41a16c27b0"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0031-8757-12)  / 118 mL in 1 BOTTLE", "package_ndc": "0031-8757-12", "marketing_start_date": "20180601"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0031-8757-18)  / 237 mL in 1 BOTTLE", "package_ndc": "0031-8757-18", "marketing_start_date": "20180601"}], "brand_name": "ROBITUSSIN COUGH PLUS CHEST CONGESTION DM", "product_id": "0031-8757_159a64fb-02c1-1365-e063-6394a90af696", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]", "Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]"], "product_ndc": "0031-8757", "generic_name": "dextromethorphan hydrobromide and guaifenesin", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "ROBITUSSIN COUGH PLUS CHEST CONGESTION DM", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/20mL"}, {"name": "GUAIFENESIN", "strength": "200 mg/20mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20180601", "listing_expiration_date": "20261231"}