Home NDC 51316-650 CVS Childrens
Product NDC 51316-650
11-digit product format 513160650
Labeler code 51316
Product ID 51316-650_1fec45d1-9c35-4e8e-b0dc-58bacda9abc6
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen and Dextromethorphan Hydrobromide
Dosage form SUSPENSION
Route ORAL
Labeler CVS PHARMACY
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-02-01
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 160; 5 mg/5mL; mg/5mL
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 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 CVS Childrens
Brand name suffix COLD PLUS COUGH PLUS SORE THROAT
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 160 mg/5mL DEXTROMETHORPHAN HYDROBROMIDE 5 mg/5mL
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 1370113 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 51316-650-04 CVS ChildrensCOLD PLUS COUGH PLUS SORE THROAT 120 mL in 1 BOTTLE SUSPENSION 120 3 51316-650-04 CVS ChildrensCOLD PLUS COUGH PLUS SORE THROAT 1 in 1 CARTON SUSPENSION 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51316-650 CVS CHILDRENS COLD PLUS COUGH PLUS SORE THROAT (ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE) SUSPENSION [CVS PHARMACY] 2 Current NDC, 2 package rows 20240326_27820bce-6638-4f17-ac66-62b02b76bec3.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 51316-650-04 51316065004 1 BOTTLE in 1 CARTON (51316-650-04) / 120 mL in 1 BOTTLE 1 bottle 2023-02-01 No No Current