Home NDC 63824-959 Mucinex Childrens FreeFrom Multi-Symptom Cold and Flu Nighttime
Product NDC 63824-959
11-digit product format 638240959
Labeler code 63824
Product ID 63824-959_5219fc2d-5851-95df-e063-6394a90ad19d
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride, and Triprolidine Hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler Reckitt Benckiser LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-06-01
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE
Active strength 325; 10; 5; 1.25 mg/10mL; mg/10mL; mg/10mL; mg/10mL
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 Mucinex Childrens FreeFrom Multi-Symptom Cold and Flu Nighttime
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/10mL DEXTROMETHORPHAN HYDROBROMIDE 10 mg/10mL PHENYLEPHRINE HYDROCHLORIDE 5 mg/10mL TRIPROLIDINE HYDROCHLORIDE 1.25 mg/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2173662 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 63824-959-64 Mucinex Childrens FreeFrom Multi-Symptom Cold and Flu Nighttime 1 in 1 CARTON SOLUTION 1 4 63824-959-64 Mucinex Childrens FreeFrom Multi-Symptom Cold and Flu Nighttime 118 mL in 1 BOTTLE SOLUTION 118 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63824-959 MUCINEX CHILDRENS FREEFROM MULTI-SYMPTOM COLD AND FLU NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE) SOLUTION [RB HEALTH (US) LLC] 3 Current NDC, Legacy NDC, 2 package rows 20241228_84e7be8f-2785-45ef-9c44-de05394fcd99.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 63824-959-64 63824095964 1 BOTTLE in 1 CARTON (63824-959-64) / 118 mL in 1 BOTTLE 1 bottle 2020-06-01 0000-00-00 No No Current