FDA.reportPublic FDA data

night time

Product NDC
37808-459
11-digit product format
378080459
Labeler code
37808
Product ID
37808-459_7feb7ae3-7241-430b-89c9-3f17adf6ff94
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
Dosage form
SOLUTION
Route
ORAL
Labeler
H E B
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-02-04
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
night time
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
37808-459-38night time296 mL in 1 BOTTLESOLUTION2968
37808-459-40night time355 mL in 1 BOTTLESOLUTION3558
37808-459-50night time2 in 1 PACKAGESOLUTION28
37808-459-50night time355 mL in 1 BOTTLESOLUTION3558

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DNIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [H E B]3
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHNIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [H E B]3
DOXYLAMINE SUCCINATEACTIVE INGREDIENTV9BI9B5YI2NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [H E B]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DNIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [H E B]3
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSNIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [H E B]3
DOXYLAMINEACTIVE MOIETY95QB77JKPLNIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [H E B]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MNIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [H E B]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLNIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [H E B]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [H E B]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [H E B]3
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SNIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [H E B]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [H E B]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [H E B]3
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYNIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [H E B]3
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRNIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [H E B]3
WATERINACTIVE INGREDIENT059QF0KO0RNIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [H E B]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-459NIGHT TIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [H E B]8Current NDC, Legacy NDC, 4 package rows20241027_cf31538c-9eee-4c81-80cb-66eecabf0aff.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 SolutionPSNcf31538c-9eee-4c81-80cb-66eecabf0aff8
1043400acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSCDcf31538c-9eee-4c81-80cb-66eecabf0aff8
1043400acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral SolutionSYcf31538c-9eee-4c81-80cb-66eecabf0aff8
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral SolutionSYcf31538c-9eee-4c81-80cb-66eecabf0aff8
1043400APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSYcf31538c-9eee-4c81-80cb-66eecabf0aff8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-459-3837808045938296 mL in 1 BOTTLE (37808-459-38) 296 ml2012-02-040000-00-00NoNoCurrent
37808-459-4037808045940355 mL in 1 BOTTLE (37808-459-40) 355 ml2012-07-200000-00-00NoNoCurrent
37808-459-50378080459502 BOTTLE in 1 PACKAGE (37808-459-50) > 355 mL in 1 BOTTLE2 bottle2012-07-200000-00-00NoNoCurrent