Home NDC 51316-630 CVS Severe Multi-Symptom Cough Cold Flu
Product NDC 51316-630
11-digit product format 513160630
Labeler code 51316
Product ID 51316-630_9c3cd2bf-17c7-4788-ae05-ffe5a2614380
Type HUMAN OTC DRUG
Nonproprietary name acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
Dosage form LIQUID
Route ORAL
Labeler CVS PHARMACY
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-01-09
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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 CVS Severe Multi-Symptom Cough Cold Flu
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 650 mg/20mL DEXTROMETHORPHAN HYDROBROMIDE 20 mg/20mL GUAIFENESIN 400 mg/20mL PHENYLEPHRINE HYDROCHLORIDE 10 mg/20mL
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 1116572 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 51316-630-04 CVS Severe Multi-Symptom Cough Cold Flu 118 mL in 1 BOTTLE LIQUID 118 5 51316-630-04 CVS Severe Multi-Symptom Cough Cold Flu 1 in 1 CARTON LIQUID 1 5 51316-630-08 CVS Severe Multi-Symptom Cough Cold Flu 237 mL in 1 BOTTLE LIQUID 237 5 51316-630-08 CVS Severe Multi-Symptom Cough Cold Flu 1 in 1 CARTON LIQUID 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51316-630 CVS SEVERE MULTI-SYMPTOM COUGH COLD FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [CVS PHARMACY] 4 Current NDC, 4 package rows 20240821_bb24c298-1d00-4378-8de3-b4056220fa75.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 Sample Exclude flag Status 51316-630-04 51316063004 1 BOTTLE in 1 CARTON (51316-630-04) / 118 mL in 1 BOTTLE 1 bottle 2023-01-09 No No Current 51316-630-08 51316063008 1 BOTTLE in 1 CARTON (51316-630-08) / 237 mL in 1 BOTTLE 1 bottle 2023-01-09 No No Current