FDA.reportPublic FDA data

up and up nighttime cold and flu

Product NDC
11673-019
11-digit product format
116730019
Labeler code
11673
Product ID
11673-019_e2e50ecf-964c-4e5c-b83f-64ffe2b8058a
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
Dosage form
SOLUTION
Route
ORAL
Labeler
Target Corporation
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-03-10
Marketing end
2026-06-30
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
up and up nighttime cold and flu

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
11673-019-40up and up nighttime cold and flu355 mL in 1 BOTTLESOLUTION3556

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DUP AND UP NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [TARGET CORPORATION]2
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHUP AND UP NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [TARGET CORPORATION]2
DOXYLAMINE SUCCINATEACTIVE INGREDIENTV9BI9B5YI2UP AND UP NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [TARGET CORPORATION]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DUP AND UP NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [TARGET CORPORATION]2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSUP AND UP NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [TARGET CORPORATION]2
DOXYLAMINEACTIVE MOIETY95QB77JKPLUP AND UP NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [TARGET CORPORATION]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MUP AND UP NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [TARGET CORPORATION]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLUP AND UP NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [TARGET CORPORATION]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDUP AND UP NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [TARGET CORPORATION]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAUP AND UP NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [TARGET CORPORATION]2
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SUP AND UP NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [TARGET CORPORATION]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AUP AND UP NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [TARGET CORPORATION]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3UP AND UP NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [TARGET CORPORATION]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYUP AND UP NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [TARGET CORPORATION]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRUP AND UP NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [TARGET CORPORATION]2
WATERINACTIVE INGREDIENT059QF0KO0RUP AND UP NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [TARGET CORPORATION]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-019UP AND UP NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [TARGET CORPORATION]6Current NDC, Legacy NDC, 1 package rows20241106_ea484857-9bdc-4319-94f4-775e3ea04402.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 SolutionPSNea484857-9bdc-4319-94f4-775e3ea044026
1043400acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSCDea484857-9bdc-4319-94f4-775e3ea044026
1043400acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral SolutionSYea484857-9bdc-4319-94f4-775e3ea044026
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral SolutionSYea484857-9bdc-4319-94f4-775e3ea044026
1043400APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSYea484857-9bdc-4319-94f4-775e3ea044026

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11673-019-4011673001940355 mL in 1 BOTTLE (11673-019-40) 355 ml2015-03-102026-06-30NoNoCurrent