FDA.reportPublic FDA data

Night Time Cough

Product NDC
49580-0499
11-digit product format
495800499
Labeler code
49580
Product ID
49580-0499_1d3399d4-3d47-44be-9438-649ba49ac02d
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan Hydrobromide, Doxylamine Succinate
Dosage form
LIQUID
Route
ORAL
Labeler
P & L Development, LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2017-12-31
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength
30 mg/30mL; mg/30mL
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct49580-0499DDiscontinued by firm2026-10-16
excluded packagepackage49580-049949580-0499-2DDiscontinued by firm2026-10-16
excluded packagepackage49580-049949580-0499-4DDiscontinued by firm2026-10-16
excluded packagepackage49580-049949580-0499-8DDiscontinued by firm2026-10-16

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
49580-0499-22023-05-24Drug Facts
49580-0499-42023-05-24Drug Facts
49580-0499-22023-01-30Drug Facts
49580-0499-42023-01-30Drug Facts

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49580-0499NIGHT TIME COUGH (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [P & L DEVELOPMENT, LLC]6Legacy NDC20250114_0083dfb6-9e47-4def-aab2-673f640866eb.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49580-0499-249580049902355 mL in 1 BOTTLE, PLASTIC (49580-0499-2) 355 ml2017-12-310000-00-00NoNoCurrent
49580-0499-449580049904118 mL in 1 BOTTLE, PLASTIC (49580-0499-4) 118 ml2017-12-310000-00-00NoNoCurrent