Nighttime Cold and Flu

Product NDC
11822-3318
11-digit product format
118223318
Labeler code
11822
Product ID
11822-3318_880d003e-696b-492d-9452-121baba8557b
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
Dosage form
LIQUID
Route
ORAL
Labeler
Rite Aid Corporation
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-11-29
Marketing end
2026-11-29
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
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
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FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-3318-0Nighttime Cold and Flu355 mL in 1 BOTTLE, PLASTICLIQUID3559
11822-3318-1Nighttime Cold and Flu355 mL in 1 BOTTLE, PLASTICLIQUID3559
11822-3318-5Nighttime Cold and Flu237 mL in 1 BOTTLE, PLASTICLIQUID2379

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-3318NIGHTTIME COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [RITE AID CORPORATION]8Current NDC, Legacy NDC, 3 package rows20240510_25bf4390-23f7-4bb6-b86e-c40eaf8d92da.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 SolutionPSN25bf4390-23f7-4bb6-b86e-c40eaf8d92da9
1043400acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSCD25bf4390-23f7-4bb6-b86e-c40eaf8d92da9
1043400acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral SolutionSY25bf4390-23f7-4bb6-b86e-c40eaf8d92da9
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral SolutionSY25bf4390-23f7-4bb6-b86e-c40eaf8d92da9
1043400APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSY25bf4390-23f7-4bb6-b86e-c40eaf8d92da9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-3318-011822331800355 mL in 1 BOTTLE, PLASTIC (11822-3318-0) 355 ml2019-11-292026-11-29NoNoCurrent
11822-3318-111822331801355 mL in 1 BOTTLE, PLASTIC (11822-3318-1) 355 ml2019-11-292026-11-29NoNoCurrent
11822-3318-511822331805237 mL in 1 BOTTLE, PLASTIC (11822-3318-5) 237 ml2019-11-292026-11-29NoNoCurrent