ONESSIP DAY TIME KIDS COLD AND COUGH PLUS FEVER

Product NDC
87078-331
11-digit product format
870780331
Labeler code
87078
Product ID
87078-331_51d52ce4-98c5-2b9b-e063-6294a90ade44
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen 325 mg and Dextromethorphan HBr 10 mg Oral Liquid Day Time Kids
Dosage form
LIQUID
Route
ORAL
Labeler
MEDWISE LIFESCIENCES INC.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-05-15
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
325; 10 mg/10mL; mg/10mL
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
362O9ITL9DACETAMINOPHEN103-90-2ACETAMINOPHEN
9D2RTI9KYHDEXTROMETHORPHAN HYDROBROMIDE6700-34-1DEXTROMETHORPHAN HYDROBROMIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87078-331-168707803311616 POUCH in 1 CARTON (87078-331-16) / 10 mL in 1 POUCH (87078-331-01) 16 pouch2026-05-15NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
ONESSIP DAY TIME KIDS COLD AND COUGH PLUS FEVERMEDWISE LIFESCIENCES INC.2026-05-15HUMAN OTC DRUG LABEL1