Home NDC 51316-500 Cough and Congestion
Product NDC 51316-500
11-digit product format 513160500
Labeler code 51316
Product ID 51316-500_dec599a2-aee8-429b-b5a9-05a7c5fb315f
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan HBr, Guaifenesin
Dosage form SOLUTION
Route ORAL
Labeler CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-04-08
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength 20; 400 mg/20mL; mg/20mL
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 Cough and Congestion
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 20 mg/20mL GUAIFENESIN 400 mg/20mL
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 1020138 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 51316-500-19 Cough and Congestion 1 in 1 CARTON SOLUTION 1 5 51316-500-19 Cough and Congestion 237 mL in 1 BOTTLE, PLASTIC SOLUTION 237 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51316-500 COUGH AND CONGESTION (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED] 5 Current NDC, 2 package rows 20250406_44fb27d3-5125-4511-84d2-76555bc46e66.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 174 of 174 · 3,464 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join DEXTROMETHORPHAN HYDROBROMIDE, Guaifenesin, and PHENYLEPHRINE HYDROCHLORIDE DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE Westminster Pharmaceuticals, LLC a58bfb14-28f9-4425-a5a5-aaff4847c979 2018-03-14 Warnings Exact identifier application number: M012 Chlorpheniramine maleate 4mg CHLORPHENIRAMINE MALEATE 4MG Athlete's Needs, Inc. 4d974959-25fc-4707-9b72-9afbf47b76f1 2017-11-14 Warnings Exact identifier application number: M012 Cold Medicine ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL Selder, S.A. de C.V. d2762d9c-e7e7-42b2-a26a-14b2aa0307cb 2017-01-25 Warnings Exact identifier application number: M012 Allergy CHLORPHENIRAMINE MALEATE Marc Glassman, Inc. 2051247f-ce64-4cf5-b449-9ca14c43ab86 2016-12-27 Warnings Exact identifier application number: M012
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 51316-500-19 51316050019 1 BOTTLE, PLASTIC in 1 CARTON (51316-500-19) / 237 mL in 1 BOTTLE, PLASTIC 2024-04-08 No No Current