Home NDC 0031-0100 Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu
Product NDC 0031-0100
11-digit product format 000310100
Labeler code 0031
Product ID 0031-0100_43e64251-a916-1cb7-e063-6294a90a393a
Type HUMAN OTC DRUG
Nonproprietary name acetaminophen, dextromethorphan hydrobromide, guaifenesin
Dosage form LIQUID
Route ORAL
Labeler Haleon US Holdings LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-02-15
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength 650; 20; 400 mg/20mL; 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 Maximum Strength Severe Multi-Symptom Cough Cold Flu
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 650 mg/20mL DEXTROMETHORPHAN HYDROBROMIDE 20 mg/20mL GUAIFENESIN 400 mg/20mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup 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 2680300 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 0031-0100-04 Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu 1 in 1 CARTON LIQUID 1 4 0031-0100-04 Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu 118 mL in 1 BOTTLE LIQUID 118 4 0031-0100-08 Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu 1 in 1 CARTON LIQUID 1 4 0031-0100-08 Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu 237 mL in 1 BOTTLE LIQUID 237 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0031-0100 ROBITUSSIN MAXIMUM STRENGTH SEVERE MULTI-SYMPTOM COUGH COLD FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [HALEON US HOLDINGS LLC] 3 Current NDC, 4 package rows 20250515_a6f750c8-8738-4965-a3ad-612c24611056.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 74 of 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0031-0100-04 00031010004 1 BOTTLE in 1 CARTON (0031-0100-04) / 118 mL in 1 BOTTLE 1 bottle 2024-02-15 No No Current 0031-0100-08 00031010008 1 BOTTLE in 1 CARTON (0031-0100-08) / 237 mL in 1 BOTTLE 1 bottle 2024-02-15 No No Current