Home NDC 51316-830 CVS Health Chest Congestion and Cough HBP SOFTGEL
Product NDC 51316-830
11-digit product format 513160830
Labeler code 51316
Product ID 51316-830_7c0d96a4-0969-424b-a720-b31b190c832b
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan hydrobromide, Guaifenesin
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler CVS Pharmacy, Inc
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-01-15
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength 10; 200 mg/1; mg/1
Pharmacologic classes 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]
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 CVS Health Chest Congestion and Cough HBP SOFTGEL
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1 GUAIFENESIN 200 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9D2RTI9KYH Internal UNII lookup 495W7451VQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1111663 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 51316-830-02 CVS Health Chest Congestion and Cough HBP SOFTGEL 2 in 1 CARTON CAPSULE, LIQUID FILLED 2 2 51316-830-02 CVS Health Chest Congestion and Cough HBP SOFTGEL 10 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 10 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51316-830 CVS HEALTH CHEST CONGESTION AND COUGH HBP SOFTGEL (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) CAPSULE, LIQUID FILLED [CVS PHARMACY, INC] 2 Current NDC, 2 package rows 20250117_2741ba44-1cc7-1812-e063-6394a90a8faa.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 99 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 51316-830-02 51316083002 2 BLISTER PACK in 1 CARTON (51316-830-02) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 2 blister pack 2025-01-15 No No Current