robitussin sugar-free dye-free cough plus chest congestion dm

Generic: dextromethorphan hydrobromide, guaifenesin

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

Drug Facts

Product Profile

Brand Name robitussin sugar-free dye-free cough plus chest congestion dm
Generic Name dextromethorphan hydrobromide, 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 0031-8759
Product ID 0031-8759_e4426213-924d-481d-a712-9dbf7875eafd
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2018-02-16

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 00318759
Hyphenated Format 0031-8759

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 sugar-free dye-free cough plus chest congestion dm (source: ndc)
Generic Name dextromethorphan hydrobromide, 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 (0031-8759-12) / 118 mL in 1 BOTTLE
source: ndc

Packages (1)

0031-8759-12 1 BOTTLE in 1 CARTON (0031-8759-12) / 118 mL in 1 BOTTLE

Ingredients (2)

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

Linked Drug Pages (1)

Robitussin Sugar-Free Dye-Free Cough Plus Chest Congestion DM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e4426213-924d-481d-a712-9dbf7875eafd", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["1790650"], "spl_set_id": ["036162c9-f5a6-418e-bd5e-ebd72097d27d"], "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 (0031-8759-12)  / 118 mL in 1 BOTTLE", "package_ndc": "0031-8759-12", "marketing_start_date": "20180216"}], "brand_name": "Robitussin Sugar-Free Dye-Free Cough Plus Chest Congestion DM", "product_id": "0031-8759_e4426213-924d-481d-a712-9dbf7875eafd", "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": "0031-8759", "generic_name": "dextromethorphan hydrobromide, guaifenesin", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Robitussin Sugar-Free Dye-Free 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": "20180216", "listing_expiration_date": "20261231"}