Daytime Cold and Flu Relief

Product NDC
55319-954
11-digit product format
553190954
Labeler code
55319
Product ID
55319-954_ec4475ec-9acf-4368-8c91-b19ecc48f076
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen Dextromethorphan HBr
Dosage form
LIQUID
Route
ORAL
Labeler
Family Dollar (FAMILY WELLNESS)
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-11-01
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
325; 10 mg/15mL; mg/15mL
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
Daytime Cold and Flu Relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/15mL
DEXTROMETHORPHAN HYDROBROMIDE10 mg/15mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, 9D2RTI9KYH
Rxcui2604561

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-954-12Daytime Cold and Flu Relief355 mL in 1 BOTTLE, PLASTICLIQUID3554

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2604561acetaminophen 650 MG / dextromethorphan HBr 20 MG in 30 mL Oral SolutionPSNfe3e74ba-31d9-4d50-ab61-ffb6aaa660854
2604561acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML Oral SolutionSCDfe3e74ba-31d9-4d50-ab61-ffb6aaa660854
2604561acetaminophen 325 MG / dextromethorphan HBr 10 MG per 15 ML Oral SolutionSYfe3e74ba-31d9-4d50-ab61-ffb6aaa660854
2604561acetaminophen 650 MG / dextromethorphan HBr 20 MG per 30 ML Oral SolutionSYfe3e74ba-31d9-4d50-ab61-ffb6aaa660854
2604561APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML Oral SolutionSYfe3e74ba-31d9-4d50-ab61-ffb6aaa660854

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55319-954-1255319095412355 mL in 1 BOTTLE, PLASTIC (55319-954-12) 355 ml2025-11-01NoNoHistorical