FDA.reportPublic FDA data

Cold and Flu Relief

Product NDC
11822-5832
11-digit product format
118225832
Labeler code
11822
Product ID
11822-5832_2dce2c3b-8c1f-43e6-a64e-3dc48834b838
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
2019-12-27
Marketing end
2026-12-27
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
Cold and Flu Relief
Brand name suffix
Nighttime

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
11822-5832-1Cold and Flu ReliefNighttime237 mL in 1 BOTTLE, PLASTICLIQUID2376
11822-5832-2Cold and Flu ReliefNighttime355 mL in 1 BOTTLE, PLASTICLIQUID3556
11822-5832-3Cold and Flu ReliefNighttime2 in 1 PACKAGELIQUID26
11822-5832-3Cold and Flu ReliefNighttime355 mL in 1 BOTTLE, PLASTICLIQUID3556

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-5832COLD AND FLU RELIEF NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [RITE AID CORPORATION]5Current NDC, Legacy NDC, 4 package rows20240510_f9b8dbe1-7ff9-4320-850c-6e86e98d4393.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 SolutionPSNf9b8dbe1-7ff9-4320-850c-6e86e98d43936
1043400acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSCDf9b8dbe1-7ff9-4320-850c-6e86e98d43936
1043400acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral SolutionSYf9b8dbe1-7ff9-4320-850c-6e86e98d43936
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral SolutionSYf9b8dbe1-7ff9-4320-850c-6e86e98d43936
1043400APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSYf9b8dbe1-7ff9-4320-850c-6e86e98d43936

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-5832-111822583201237 mL in 1 BOTTLE, PLASTIC (11822-5832-1) 237 ml2019-12-272026-12-27NoNoCurrent
11822-5832-211822583202355 mL in 1 BOTTLE, PLASTIC (11822-5832-2) 355 ml2019-12-272026-12-27NoNoCurrent
11822-5832-3118225832032 BOTTLE, PLASTIC in 1 PACKAGE (11822-5832-3) / 355 mL in 1 BOTTLE, PLASTIC2019-12-272026-12-27NoNoCurrent