Home NDC 0031-8744 Robitussin Maximum Strength Severe Multi-Symptom 7 in 1 Relief Nighttime
Product NDC 0031-8744
11-digit product format 000318744
Labeler code 0031
Product ID 0031-8744_156fd078-37b4-ddce-e063-6294a90ae226
Type HUMAN OTC DRUG
Nonproprietary name acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Haleon US Holdings LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-07-01
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength 325; 15; 6.25 mg/1; mg/1; mg/1
Pharmacologic classes Antihistamine [EPC], Histamine Receptor Antagonists [MoA], 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 7 in 1 Relief Nighttime
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1 DOXYLAMINE SUCCINATE 6.25 mg/1
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 V9BI9B5YI2 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1094549 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 0031-8744-10 Robitussin Maximum Strength Severe Multi-Symptom 7 in 1 Relief Nighttime 5 in 1 CARTON CAPSULE, LIQUID FILLED 5 5 0031-8744-10 Robitussin Maximum Strength Severe Multi-Symptom 7 in 1 Relief Nighttime 2 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 2 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0031-8744 ROBITUSSIN MAXIMUM STRENGTH SEVERE MULTI-SYMPTOM 7 IN 1 RELIEF NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [HALEON US HOLDINGS LLC] 5 Current NDC, Legacy NDC, 2 package rows 20240408_e7cf7c5d-5c9a-4201-9e30-1cd616071855.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 0031-8744-10 00031874410 5 BLISTER PACK in 1 CARTON (0031-8744-10) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 5 blister pack 2018-07-01 0000-00-00 No No Current