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

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
IngredientStrength
ACETAMINOPHEN325 mg/10mL
DEXTROMETHORPHAN HYDROBROMIDE10 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, 9D2RTI9KYH
Rxcui1919076

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87078-331-01ONESSIP DAY TIME KIDS COLD AND COUGH PLUS FEVER10 mL in 1 POUCHLIQUID101
87078-331-16ONESSIP DAY TIME KIDS COLD AND COUGH PLUS FEVER16 in 1 CARTONLIQUID161

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1919076acetaminophen 325 MG / dextromethorphan HBr 10 MG in 10 mL Oral SolutionPSN51d52ce4-98c4-2b9b-e063-6294a90ade441
1919076acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral SolutionSCD51d52ce4-98c4-2b9b-e063-6294a90ade441
1919076acetaminophen 325 MG / dextromethorphan HBr 10 MG per 10 mL Oral SolutionSY51d52ce4-98c4-2b9b-e063-6294a90ade441
1919076acetaminophen 650 MG / dextromethorphan HBr 20 MG per 20 mL Oral SolutionSY51d52ce4-98c4-2b9b-e063-6294a90ade441
1919076APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML Oral SolutionSY51d52ce4-98c4-2b9b-e063-6294a90ade441

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87078-331-018707803310110 mL in 1 POUCH10 mlHistorical
87078-331-168707803311616 POUCH in 1 CARTON (87078-331-16) / 10 mL in 1 POUCH (87078-331-01) 16 pouch2026-05-15NoNoCurrent