Home NDC 63824-951 Mucinex Childrens
Product NDC 63824-951
11-digit product format 638240951
Labeler code 63824
Product ID 63824-951_5219dba6-d039-bbe9-e063-6294a90ab47f
Type HUMAN OTC DRUG
Nonproprietary name Guaifenesin and Phenylephrine Hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler Reckitt Benckiser LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-05-01
Substance GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 100; 2.5 mg/5mL; mg/5mL
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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
Brand name suffix Stuffy Nose and Chest Congestion
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GUAIFENESIN 100 mg/5mL PHENYLEPHRINE HYDROCHLORIDE 2.5 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 495W7451VQ Internal UNII lookup 04JA59TNSJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1485599 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 63824-951-07 Mucinex ChildrensStuffy Nose and Chest Congestion 118 mL in 1 BOTTLE SOLUTION 118 5 63824-951-07 Mucinex ChildrensStuffy Nose and Chest Congestion 1 in 1 CARTON SOLUTION 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63824-951 MUCINEX CHILDRENS STUFFY NOSE AND CHEST CONGESTION (GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [RB HEALTH (US) LLC] 4 Current NDC, Legacy NDC, 2 package rows 20241222_7354f57c-0ecf-481f-9482-0040c90c4350.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 177 · 3,534 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 63824-951-07 63824095107 1 BOTTLE in 1 CARTON (63824-951-07) / 118 mL in 1 BOTTLE 1 bottle 2018-05-01 0000-00-00 No No Current