FDA.reportPublic FDA data

Mucus Relief Cough

Product NDC
49580-0294
11-digit product format
495800294
Labeler code
49580
Product ID
49580-0294_d4d3bb36-237b-456a-8fed-bb17ffd760eb
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifensin
Dosage form
LIQUID
Route
ORAL
Labeler
P & L Development, LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-03-26
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
5 mg/5mL; mg/5mL
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 productproduct49580-0294DDiscontinued by firm2026-10-15
excluded packagepackage49580-029449580-0294-4DDiscontinued by firm2026-10-15

Reported adverse events (FAERS/openFDA)#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49580-0294MUCUS RELIEF COUGH CHILDRENS (DEXTROMETHORPHAN HBR, GUAIFENSIN) LIQUID [P & L DEVELOPMENT, LLC]3Legacy NDC20241025_d70cd240-2cea-4131-9c0a-dc9a22982bad.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49580-0294-4495800294041 BOTTLE, PLASTIC in 1 BOX (49580-0294-4) > 118 mL in 1 BOTTLE, PLASTIC2021-03-260000-00-00NoNoCurrent