Home NDC 0031-8759 Robitussin Sugar-Free Dye-Free Cough Plus Chest Congestion DM
Product NDC 0031-8759
11-digit product format 000318759
Labeler code 0031
Product ID 0031-8759_e4426213-924d-481d-a712-9dbf7875eafd
Type HUMAN OTC DRUG
Nonproprietary name dextromethorphan hydrobromide, guaifenesin
Dosage form SOLUTION
Route ORAL
Labeler Haleon US Holdings LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-02-16
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength 20; 200 mg/20mL; mg/20mL
Pharmacologic classes 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]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Robitussin Sugar-Free Dye-Free Cough Plus Chest Congestion DM
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 20 mg/20mL GUAIFENESIN 200 mg/20mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9D2RTI9KYH Internal UNII lookup 495W7451VQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1790650 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0031-8759-12 Robitussin Sugar-Free Dye-Free Cough Plus Chest Congestion DM 118 mL in 1 BOTTLE SOLUTION 118 7 0031-8759-12 Robitussin Sugar-Free Dye-Free Cough Plus Chest Congestion DM 1 in 1 CARTON SOLUTION 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0031-8759 ROBITUSSIN SUGAR-FREE DYE-FREE COUGH PLUS CHEST CONGESTION DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [HALEON US HOLDINGS LLC] 7 Current NDC, Legacy NDC, 2 package rows 20240316_036162c9-f5a6-418e-bd5e-ebd72097d27d.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 73 of 178 · 3,550 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0031-8759-12 00031875912 1 BOTTLE in 1 CARTON (0031-8759-12) / 118 mL in 1 BOTTLE 1 bottle 2018-02-16 0000-00-00 No No Current