Nitetime Cough

Product NDC
41250-668
Requested package NDC
41250-668-40
11-digit product format
412500668
Labeler code
41250
Product ID
41250-668_4fea6285-8867-4eea-94db-84a65ce2ace0
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan Hydrobromide, Doxylamine Succinate
Dosage form
SOLUTION
Route
ORAL
Labeler
Meijer Distribution Inc
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2003-03-03
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage41250-66841250-668-40DDiscontinued 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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage41250-66841250-668-40DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage41250-66841250-668-40DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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 INGREDIENT9D2RTI9KYHNITETIME COUGH (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [MEIJER DISTRIBUTION INC]3
DOXYLAMINE SUCCINATEACTIVE INGREDIENTV9BI9B5YI2NITETIME COUGH (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [MEIJER DISTRIBUTION INC]3
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSNITETIME COUGH (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [MEIJER DISTRIBUTION INC]3
DOXYLAMINEACTIVE MOIETY95QB77JKPLNITETIME COUGH (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [MEIJER DISTRIBUTION INC]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MNITETIME COUGH (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [MEIJER DISTRIBUTION INC]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLNITETIME COUGH (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [MEIJER DISTRIBUTION INC]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNITETIME COUGH (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [MEIJER DISTRIBUTION INC]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANITETIME COUGH (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [MEIJER DISTRIBUTION INC]3
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SNITETIME COUGH (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [MEIJER DISTRIBUTION INC]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANITETIME COUGH (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [MEIJER DISTRIBUTION INC]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NITETIME COUGH (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [MEIJER DISTRIBUTION INC]3
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYNITETIME COUGH (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [MEIJER DISTRIBUTION INC]3
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRNITETIME COUGH (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [MEIJER DISTRIBUTION INC]3
WATERINACTIVE INGREDIENT059QF0KO0RNITETIME COUGH (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [MEIJER DISTRIBUTION INC]3
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHNITETIME COUGH DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [MEIJER DISTRIBUTION INC]1
DOXYLAMINE SUCCINATEACTIVE INGREDIENTV9BI9B5YI2NITETIME COUGH DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [MEIJER DISTRIBUTION INC]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSNITETIME COUGH DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [MEIJER DISTRIBUTION INC]1
DOXYLAMINEACTIVE MOIETY95QB77JKPLNITETIME COUGH DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [MEIJER DISTRIBUTION INC]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MNITETIME COUGH DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [MEIJER DISTRIBUTION INC]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLNITETIME COUGH DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [MEIJER DISTRIBUTION INC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNITETIME COUGH DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [MEIJER DISTRIBUTION INC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNITETIME COUGH DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [MEIJER DISTRIBUTION INC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANITETIME COUGH DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [MEIJER DISTRIBUTION INC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8NITETIME COUGH DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [MEIJER DISTRIBUTION INC]1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SNITETIME COUGH DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [MEIJER DISTRIBUTION INC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANITETIME COUGH DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [MEIJER DISTRIBUTION INC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NITETIME COUGH DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [MEIJER DISTRIBUTION INC]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYNITETIME COUGH DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [MEIJER DISTRIBUTION INC]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRNITETIME COUGH DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [MEIJER DISTRIBUTION INC]1
WATERINACTIVE INGREDIENT059QF0KO0RNITETIME COUGH DAYTIME COUGH (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) KIT [MEIJER DISTRIBUTION INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-668NITETIME COUGH (DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) SOLUTION [MEIJER DISTRIBUTION INC]10Legacy NDC20241025_2f747101-b7e2-4805-bdbd-e98725b7330f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-668-4041250066840355 mL in 1 BOTTLE (41250-668-40) 355 ml2012-10-240000-00-00NoNoCurrent