DayQuil Severe VapoCool Cold and Flu

Product NDC
50269-554
11-digit product format
502690554
Labeler code
50269
Product ID
50269-554_4d785957-0ee7-fe48-e063-6394a90a06ec
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE
Dosage form
TABLET, COATED
Route
ORAL
Labeler
J.C. World Bell Wholesale Co., Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-05-06
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
325; 10 mg/1; mg/1
Pharmacologic classes
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DayQuil Severe VapoCool Cold and Flu
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
DEXTROMETHORPHAN HYDROBROMIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, 9D2RTI9KYH
Rxcui2709673

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50269-554-01DayQuil Severe VapoCool Cold and Flu6 in 1 BOXTABLET, COATED61
50269-554-01DayQuil Severe VapoCool Cold and Flu1 in 1 BLISTER PACKTABLET, COATED11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2709673acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral TabletPSNf29e9089-f524-4a31-a786-51fe76acc31a1
2709673acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG Oral TabletSCDf29e9089-f524-4a31-a786-51fe76acc31a1
2709673acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral TabletSYf29e9089-f524-4a31-a786-51fe76acc31a1
2709673APAP 325 MG / dextromethorphan hydrobromide 10 MG Oral TabletSYf29e9089-f524-4a31-a786-51fe76acc31a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50269-554-01502690554016 BLISTER PACK in 1 BOX (50269-554-01) / 1 POUCH in 1 BLISTER PACK / 2 TABLET, COATED in 1 POUCH6 blister pack2025-05-06NoNoCurrent