Mucus Relief Severe Congestion and Cough

Product NDC
50804-337
11-digit product format
508040337
Labeler code
50804
Product ID
50804-337_5a467ebe-bf4c-4754-ae6c-8f95e4fb7a74
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
Dosage form
LIQUID
Route
ORAL
Labeler
Good Sense (Geiss, Destin & Dunn, Inc.)
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2016-09-30
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
20 mg/20mL; mg/20mL; mg/20mL
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50804-337DDiscontinued by firm2026-10-15
excluded packagepackage50804-33750804-337-06DDiscontinued by firm2026-10-15

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50804-337-06ML - Milliliter50804-33743035662-9bb8-41b0-a823-df096ed6d16112022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50804-337MUCUS RELIEF SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [GOOD SENSE (GEISS, DESTIN & DUNN, INC.)]5Legacy NDC20241025_0068fd01-b8f3-464e-ab9c-c4738df8c446.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50804-337-0650804033706177 mL in 1 BOTTLE, PLASTIC (50804-337-06) 177 ml2016-09-300000-00-00NoNoCurrent