Home NDC 87078-331 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 DEXTROMETHORPHAN HYDROBROMIDE; ACETAMINOPHEN
Active strength 10; 325 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 Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base ONESSIP DAY TIME KIDS COLD AND COUGH PLUS FEVER
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 10 mg/10mL ACETAMINOPHEN 325 mg/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9D2RTI9KYH Internal UNII lookup 362O9ITL9D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1919076 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 87078-331-01 ONESSIP DAY TIME KIDS COLD AND COUGH PLUS FEVER 10 mL in 1 POUCH LIQUID 10 1 87078-331-16 ONESSIP DAY TIME KIDS COLD AND COUGH PLUS FEVER 16 in 1 CARTON LIQUID 16 1
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 74 of 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 87078-331-01 87078033101 10 mL in 1 POUCH 10 ml Historical 87078-331-16 87078033116 16 POUCH in 1 CARTON (87078-331-16) / 10 mL in 1 POUCH (87078-331-01) 16 pouch 2026-05-15 No No Current