nitetime cold and flu

Product NDC
41250-335
11-digit product format
412500335
Labeler code
41250
Product ID
41250-335_d30b1a85-a76e-486c-b145-cac3cda64450
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
Dosage form
SOLUTION
Route
ORAL
Labeler
Meijer Distribution Inc
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-09-21
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength
650; 30; 12.5 mg/30mL; 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
nitetime cold and flu
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN650 mg/30mL
DEXTROMETHORPHAN HYDROBROMIDE30 mg/30mL
DOXYLAMINE SUCCINATE12.5 mg/30mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, 9D2RTI9KYH, V9BI9B5YI2
Rxcui1043400

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41250-335-38nitetime cold and flu296 mL in 1 BOTTLESOLUTION2969
41250-335-40nitetime cold and flu355 mL in 1 BOTTLESOLUTION3559
41250-335-43nitetime cold and flu473 mL in 1 BOTTLESOLUTION4739

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DNITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MEIJER DISTRIBUTION INC]4
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHNITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MEIJER DISTRIBUTION INC]4
DOXYLAMINE SUCCINATEACTIVE INGREDIENTV9BI9B5YI2NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MEIJER DISTRIBUTION INC]4
ACETAMINOPHENACTIVE MOIETY362O9ITL9DNITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MEIJER DISTRIBUTION INC]4
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSNITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MEIJER DISTRIBUTION INC]4
DOXYLAMINEACTIVE MOIETY95QB77JKPLNITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MEIJER DISTRIBUTION INC]4
ALCOHOLINACTIVE INGREDIENT3K9958V90MNITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MEIJER DISTRIBUTION INC]4
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLNITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MEIJER DISTRIBUTION INC]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MEIJER DISTRIBUTION INC]4
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SNITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MEIJER DISTRIBUTION INC]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MEIJER DISTRIBUTION INC]4
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SNITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MEIJER DISTRIBUTION INC]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MEIJER DISTRIBUTION INC]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MEIJER DISTRIBUTION INC]4
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYNITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MEIJER DISTRIBUTION INC]4
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRNITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MEIJER DISTRIBUTION INC]4
WATERINACTIVE INGREDIENT059QF0KO0RNITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MEIJER DISTRIBUTION INC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-335NITETIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [MEIJER DISTRIBUTION INC]9Current NDC, Legacy NDC, 3 package rows20241218_dcc12bc2-4bb4-4d2d-8206-b9db9843ec8b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral SolutionPSNdcc12bc2-4bb4-4d2d-8206-b9db9843ec8b9
1043400acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSCDdcc12bc2-4bb4-4d2d-8206-b9db9843ec8b9
1043400acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral SolutionSYdcc12bc2-4bb4-4d2d-8206-b9db9843ec8b9
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral SolutionSYdcc12bc2-4bb4-4d2d-8206-b9db9843ec8b9
1043400APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSYdcc12bc2-4bb4-4d2d-8206-b9db9843ec8b9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-335-3841250033538296 mL in 1 BOTTLE296 mlHistorical
41250-335-4041250033540355 mL in 1 BOTTLE (41250-335-40) 355 ml2012-10-240000-00-00NoNoCurrent
41250-335-4341250033543473 mL in 1 BOTTLE473 mlHistorical