Nighttime Cold and Flu Relief

Product NDC
59779-335
11-digit product format
597790335
Labeler code
59779
Product ID
59779-335_3a7d9551-e73e-462c-b69a-f241de84ac6a
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
Dosage form
SOLUTION
Route
ORAL
Labeler
CVS Pharmacy
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-08-16
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
Nighttime 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59779-335-30Nighttime Cold and Flu Relief177 mL in 1 BOTTLESOLUTION1778
59779-335-34Nighttime Cold and Flu Relief237 mL in 1 BOTTLESOLUTION2378
59779-335-38Nighttime Cold and Flu Relief295 mL in 1 BOTTLESOLUTION2958
59779-335-40Nighttime Cold and Flu Relief355 mL in 1 BOTTLESOLUTION3558
59779-335-50Nighttime Cold and Flu Relief355 mL in 1 BOTTLESOLUTION3558
59779-335-50Nighttime Cold and Flu Relief2 in 1 PACKAGESOLUTION28

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59779-335-34ML - Milliliter59779-3357974239f-38a1-47aa-864a-c8c06090c04d12020-05-08
59779-335-40ML - Milliliter59779-3350b6b33f1-4bc9-4a7e-9e54-a2f521e3aa4012022-06-06
59779-335-50ML - Milliliter59779-335f052481f-a3a0-4fc1-8ae2-427d42b7396d12022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DNIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [CVS PHARMACY]4
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHNIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [CVS PHARMACY]4
DOXYLAMINE SUCCINATEACTIVE INGREDIENTV9BI9B5YI2NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [CVS PHARMACY]4
ACETAMINOPHENACTIVE MOIETY362O9ITL9DNIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [CVS PHARMACY]4
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSNIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [CVS PHARMACY]4
DOXYLAMINEACTIVE MOIETY95QB77JKPLNIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [CVS PHARMACY]4
ALCOHOLINACTIVE INGREDIENT3K9958V90MNIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [CVS PHARMACY]4
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLNIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [CVS PHARMACY]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [CVS PHARMACY]4
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SNIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [CVS PHARMACY]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [CVS PHARMACY]4
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SNIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [CVS PHARMACY]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [CVS PHARMACY]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [CVS PHARMACY]4
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYNIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [CVS PHARMACY]4
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRNIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [CVS PHARMACY]4
WATERINACTIVE INGREDIENT059QF0KO0RNIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [CVS PHARMACY]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-335NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [CVS PHARMACY]8Current NDC, Legacy NDC, 6 package rows20241025_c5dd40e5-b4e2-4963-9a53-b71da1ed5510.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 SolutionPSNc5dd40e5-b4e2-4963-9a53-b71da1ed55108
1043400acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSCDc5dd40e5-b4e2-4963-9a53-b71da1ed55108
1043400acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral SolutionSYc5dd40e5-b4e2-4963-9a53-b71da1ed55108
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral SolutionSYc5dd40e5-b4e2-4963-9a53-b71da1ed55108
1043400APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSYc5dd40e5-b4e2-4963-9a53-b71da1ed55108

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-335-3059779033530177 mL in 1 BOTTLE (59779-335-30) 177 ml2011-09-020000-00-00NoNoCurrent
59779-335-3459779033534237 mL in 1 BOTTLE (59779-335-34) 237 ml2012-07-260000-00-00NoNoCurrent
59779-335-3859779033538295 mL in 1 BOTTLE (59779-335-38) 295 ml2011-09-080000-00-00NoNoCurrent
59779-335-4059779033540355 mL in 1 BOTTLE (59779-335-40) 355 ml2011-08-160000-00-00NoNoCurrent
59779-335-50597790335502 BOTTLE in 1 PACKAGE (59779-335-50) > 355 mL in 1 BOTTLE2 bottle2011-08-160000-00-00NoNoCurrent