dg health night time cold and flu relief

Product NDC
55910-335
11-digit product format
559100335
Labeler code
55910
Product ID
55910-335_cdb5731b-c7b5-4412-a438-d67466827bbd
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
Dosage form
SOLUTION
Route
ORAL
Labeler
Dolgencorp Inc
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-08-17
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
dg health night time cold and flu relief
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-335-34dg health night time cold and flu relief237 mL in 1 BOTTLESOLUTION23711
55910-335-38dg health night time cold and flu relief296 mL in 1 BOTTLESOLUTION29611
55910-335-40dg health night time cold and flu relief355 mL in 1 BOTTLESOLUTION35511

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DDG HEALTH NIGHT TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [DOLGENCORP, LLC]3
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHDG HEALTH NIGHT TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [DOLGENCORP, LLC]3
DOXYLAMINE SUCCINATEACTIVE INGREDIENTV9BI9B5YI2DG HEALTH NIGHT TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [DOLGENCORP, LLC]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DDG HEALTH NIGHT TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [DOLGENCORP, LLC]3
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSDG HEALTH NIGHT TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [DOLGENCORP, LLC]3
DOXYLAMINEACTIVE MOIETY95QB77JKPLDG HEALTH NIGHT TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [DOLGENCORP, LLC]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MDG HEALTH NIGHT TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [DOLGENCORP, LLC]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLDG HEALTH NIGHT TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [DOLGENCORP, LLC]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDG HEALTH NIGHT TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [DOLGENCORP, LLC]3
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SDG HEALTH NIGHT TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [DOLGENCORP, LLC]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DG HEALTH NIGHT TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [DOLGENCORP, LLC]3
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SDG HEALTH NIGHT TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [DOLGENCORP, LLC]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADG HEALTH NIGHT TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [DOLGENCORP, LLC]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DG HEALTH NIGHT TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [DOLGENCORP, LLC]3
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYDG HEALTH NIGHT TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [DOLGENCORP, LLC]3
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRDG HEALTH NIGHT TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [DOLGENCORP, LLC]3
WATERINACTIVE INGREDIENT059QF0KO0RDG HEALTH NIGHT TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [DOLGENCORP, LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-335DG HEALTH NIGHT TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [DOLGENCORP, LLC]10Current NDC, Legacy NDC, 3 package rows20241027_dc8cc7a3-60a9-42f0-babd-d3c7d0276dd1.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 SolutionPSNdc8cc7a3-60a9-42f0-babd-d3c7d0276dd111
1043400acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSCDdc8cc7a3-60a9-42f0-babd-d3c7d0276dd111
1043400acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral SolutionSYdc8cc7a3-60a9-42f0-babd-d3c7d0276dd111
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral SolutionSYdc8cc7a3-60a9-42f0-babd-d3c7d0276dd111
1043400APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSYdc8cc7a3-60a9-42f0-babd-d3c7d0276dd111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-335-3455910033534237 mL in 1 BOTTLE (55910-335-34) 237 ml2019-06-110000-00-00NoNoCurrent
55910-335-3855910033538296 mL in 1 BOTTLE296 mlHistorical
55910-335-4055910033540355 mL in 1 BOTTLE (55910-335-40) 355 ml2015-05-060000-00-00NoNoCurrent