FDA.reportPublic FDA data

Cold and Flu

Product NDC
63941-344
11-digit product format
639410344
Labeler code
63941
Product ID
63941-344_5dcf15f7-8630-4ef7-b5d9-683864e7b347
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate
Dosage form
LIQUID
Route
ORAL
Labeler
Best Choice (Valu Merchandisers Company)
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-10-31
Marketing end
2027-07-28
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
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
63941-344-08Cold and FluNighttime237 mL in 1 BOTTLE, PLASTICLIQUID23710
63941-344-12Cold and FluNighttime355 mL in 1 BOTTLE, PLASTICLIQUID35510

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63941-344COLD AND FLU NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) LIQUID [BEST CHOICE (VALU MERCHANDISERS COMPANY)]8Current NDC, Legacy NDC, 2 package rows20240822_d1131759-dd2e-4c06-bb73-92dd975f5511.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 SolutionPSNd1131759-dd2e-4c06-bb73-92dd975f551110
1043400acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSCDd1131759-dd2e-4c06-bb73-92dd975f551110
1043400acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral SolutionSYd1131759-dd2e-4c06-bb73-92dd975f551110
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral SolutionSYd1131759-dd2e-4c06-bb73-92dd975f551110
1043400APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSYd1131759-dd2e-4c06-bb73-92dd975f551110

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63941-344-0863941034408237 mL in 1 BOTTLE, PLASTIC (63941-344-08) 237 ml2016-10-312027-07-28NoNoCurrent
63941-344-1263941034412355 mL in 1 BOTTLE, PLASTIC (63941-344-12) 355 ml2016-10-312027-07-28NoNoCurrent