dg health cough

Product NDC
55910-668
11-digit product format
559100668
Labeler code
55910
Product ID
55910-668_4f88babf-95fc-4f08-afea-3a157e9dc4ec
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan Hydrobromide, Doxylamine Succinate
Dosage form
SOLUTION
Route
ORAL
Labeler
Dolgencorp, LLC
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2009-11-21
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength
30 mg/30mL; mg/30mL
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA], 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
2023-12-31
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 productproduct55910-668DDiscontinued by firm2026-10-05
excluded packagepackage55910-66855910-668-34DDiscontinued by firm2026-10-05
excluded packagepackage55910-66855910-668-38DDiscontinued by firm2026-10-05
excluded packagepackage55910-66855910-668-40DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55910-668-38d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55910-668-34d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55910-668-40d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55910-668-38f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55910-668-34f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55910-668-40f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55910-668-382ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55910-668-38a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55910-668-38cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55910-668-38cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55910-668-38302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55910-668-38ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55910-668-380efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55910-668-38ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55910-668-38367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55910-668-38557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHDG HEALTH COUGH NIGHT TIME (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DOLGENCORP, LLC]4
DOXYLAMINE SUCCINATEACTIVE INGREDIENTV9BI9B5YI2DG HEALTH COUGH NIGHT TIME (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DOLGENCORP, LLC]4
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSDG HEALTH COUGH NIGHT TIME (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DOLGENCORP, LLC]4
DOXYLAMINEACTIVE MOIETY95QB77JKPLDG HEALTH COUGH NIGHT TIME (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DOLGENCORP, LLC]4
ALCOHOLINACTIVE INGREDIENT3K9958V90MDG HEALTH COUGH NIGHT TIME (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DOLGENCORP, LLC]4
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLDG HEALTH COUGH NIGHT TIME (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DOLGENCORP, LLC]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDG HEALTH COUGH NIGHT TIME (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DOLGENCORP, LLC]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADG HEALTH COUGH NIGHT TIME (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DOLGENCORP, LLC]4
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SDG HEALTH COUGH NIGHT TIME (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DOLGENCORP, LLC]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADG HEALTH COUGH NIGHT TIME (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DOLGENCORP, LLC]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DG HEALTH COUGH NIGHT TIME (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DOLGENCORP, LLC]4
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYDG HEALTH COUGH NIGHT TIME (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DOLGENCORP, LLC]4
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRDG HEALTH COUGH NIGHT TIME (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DOLGENCORP, LLC]4
WATERINACTIVE INGREDIENT059QF0KO0RDG HEALTH COUGH NIGHT TIME (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DOLGENCORP, LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-668DG HEALTH COUGH NIGHT TIME (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) SOLUTION [DOLGENCORP, LLC]9Legacy NDC20241024_d26d12d6-b44a-4f33-bf8b-bc0f9c55d2fe.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-668-3455910066834237 mL in 1 BOTTLE (55910-668-34) 237 ml2021-05-250000-00-00NoNoCurrent
55910-668-3855910066838296 mL in 1 BOTTLE (55910-668-38) 296 ml2009-11-210000-00-00NoNoCurrent
55910-668-4055910066840355 mL in 1 BOTTLE (55910-668-40) 355 ml2015-05-060000-00-00NoNoCurrent