Home NDC 0031-8750 Robitussin Maximum Strength Severe Cough Plus Sore Throat
Product NDC 0031-8750
11-digit product format 000318750
Labeler code 0031
Product ID 0031-8750_4380fed9-2211-3875-e063-6394a90ab5ea
Type HUMAN OTC DRUG
Nonproprietary name acetaminophen, dextromethorphan hydrobromide
Dosage form LIQUID
Route ORAL
Labeler Haleon US Holdings LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2017-04-10
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 650; 20 mg/20mL; mg/20mL
Pharmacologic classes 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 Cough Plus Sore Throat
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 650 mg/20mL DEXTROMETHORPHAN HYDROBROMIDE 20 mg/20mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup 9D2RTI9KYH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1919076 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 0031-8750-12 Robitussin Maximum Strength Severe Cough Plus Sore Throat 118 mL in 1 BOTTLE LIQUID 118 11 0031-8750-12 Robitussin Maximum Strength Severe Cough Plus Sore Throat 1 in 1 CARTON LIQUID 1 11 0031-8750-18 Robitussin Maximum Strength Severe Cough Plus Sore Throat 1 in 1 CARTON LIQUID 1 11 0031-8750-18 Robitussin Maximum Strength Severe Cough Plus Sore Throat 237 mL in 1 BOTTLE LIQUID 237 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0031-8750 ROBITUSSIN MAXIMUM STRENGTH SEVERE COUGH PLUS SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [HALEON US HOLDINGS LLC] 10 Current NDC, Legacy NDC, 4 package rows 20250515_6a6f5da8-6433-4284-8df7-2d5b099b74dc.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 · 3,551 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 0031-8750-12 00031875012 1 BOTTLE in 1 CARTON (0031-8750-12) / 118 mL in 1 BOTTLE 1 bottle 2017-04-10 0000-00-00 No No Current 0031-8750-18 00031875018 1 BOTTLE in 1 CARTON (0031-8750-18) / 237 mL in 1 BOTTLE 1 bottle 2017-04-10 0000-00-00 No No Current