NIGHT-TIME

Product NDC
53942-502
11-digit product format
539420502
Labeler code
53942
Product ID
53942-502_c10720f3-54c8-43ad-b28a-941b3c557773
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Dosage form
LIQUID
Route
ORAL
Labeler
DeMoulas Market Basket
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-10-01
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
Brand name suffix
MULTI-SYMPTOM COLD/FLU Cherry
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
53942-502-28NIGHT-TIMEMULTI-SYMPTOM COLD/FLU Cherry354 mL in 1 BOTTLELIQUID3548

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DNIGHT-TIME MULTI-SYMPTOM COLD/FLU CHERRY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DEMOULAS MARKET BASKET]6
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHNIGHT-TIME MULTI-SYMPTOM COLD/FLU CHERRY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DEMOULAS MARKET BASKET]6
DOXYLAMINE SUCCINATEACTIVE INGREDIENTV9BI9B5YI2NIGHT-TIME MULTI-SYMPTOM COLD/FLU CHERRY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DEMOULAS MARKET BASKET]6
ACETAMINOPHENACTIVE MOIETY362O9ITL9DNIGHT-TIME MULTI-SYMPTOM COLD/FLU CHERRY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DEMOULAS MARKET BASKET]6
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSNIGHT-TIME MULTI-SYMPTOM COLD/FLU CHERRY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DEMOULAS MARKET BASKET]6
DOXYLAMINEACTIVE MOIETY95QB77JKPLNIGHT-TIME MULTI-SYMPTOM COLD/FLU CHERRY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DEMOULAS MARKET BASKET]6
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPNIGHT-TIME MULTI-SYMPTOM COLD/FLU CHERRY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DEMOULAS MARKET BASKET]6
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNIGHT-TIME MULTI-SYMPTOM COLD/FLU CHERRY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DEMOULAS MARKET BASKET]6
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANIGHT-TIME MULTI-SYMPTOM COLD/FLU CHERRY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DEMOULAS MARKET BASKET]6
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNIGHT-TIME MULTI-SYMPTOM COLD/FLU CHERRY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DEMOULAS MARKET BASKET]6
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQNIGHT-TIME MULTI-SYMPTOM COLD/FLU CHERRY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DEMOULAS MARKET BASKET]6
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NIGHT-TIME MULTI-SYMPTOM COLD/FLU CHERRY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DEMOULAS MARKET BASKET]6
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYNIGHT-TIME MULTI-SYMPTOM COLD/FLU CHERRY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DEMOULAS MARKET BASKET]6
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUNIGHT-TIME MULTI-SYMPTOM COLD/FLU CHERRY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DEMOULAS MARKET BASKET]6
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRNIGHT-TIME MULTI-SYMPTOM COLD/FLU CHERRY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DEMOULAS MARKET BASKET]6
SUCROSEINACTIVE INGREDIENTC151H8M554NIGHT-TIME MULTI-SYMPTOM COLD/FLU CHERRY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DEMOULAS MARKET BASKET]6
WATERINACTIVE INGREDIENT059QF0KO0RNIGHT-TIME MULTI-SYMPTOM COLD/FLU CHERRY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DEMOULAS MARKET BASKET]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53942-502NIGHT-TIME MULTI-SYMPTOM COLD/FLU CHERRY (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [DEMOULAS MARKET BASKET]8Current NDC, Legacy NDC, 1 package rows20231230_e772cdf5-d01d-4752-8cfb-7e7f4d7a8dd0.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 SolutionPSNe772cdf5-d01d-4752-8cfb-7e7f4d7a8dd08
1043400acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSCDe772cdf5-d01d-4752-8cfb-7e7f4d7a8dd08
1043400acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral SolutionSYe772cdf5-d01d-4752-8cfb-7e7f4d7a8dd08
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral SolutionSYe772cdf5-d01d-4752-8cfb-7e7f4d7a8dd08
1043400APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSYe772cdf5-d01d-4752-8cfb-7e7f4d7a8dd08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53942-502-2853942050228354 mL in 1 BOTTLE (53942-502-28) 354 ml2012-10-010000-00-00NoNoCurrent