Home NDC 0031-0101 Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttime
Product NDC 0031-0101
11-digit product format 000310101
Labeler code 0031
Product ID 0031-0101_0f9df094-b106-76fc-e063-6294a90a6a18
Type HUMAN OTC DRUG
Nonproprietary name acetaminophen, diphenhydramine hcl
Dosage form LIQUID
Route ORAL
Labeler Haleon US Holdings LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-02-15
Substance ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 650; 25 mg/20mL; mg/20mL
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
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 Nighttime
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 650 mg/20mL DIPHENHYDRAMINE HYDROCHLORIDE 25 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 TC2D6JAD40 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2374554 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 0031-0101-04 Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttime 1 in 1 CARTON LIQUID 1 1 0031-0101-04 Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttime 118 mL in 1 BOTTLE LIQUID 118 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0031-0101 ROBITUSSIN MAXIMUM STRENGTH SEVERE MULTI-SYMPTOM COUGH COLD FLU NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) LIQUID [HALEON US HOLDINGS LLC] 1 Current NDC, 2 package rows 20240215_721bfee2-0d3d-4d8b-beee-1ea83064d1c8.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 0031-0101-04 00031010104 1 BOTTLE in 1 CARTON (0031-0101-04) / 118 mL in 1 BOTTLE 1 bottle 2024-02-15 No No Current