FDA.reportPublic FDA data

Family Dollar Nighttime Cold and Flu Relief

Product NDC
55319-692
11-digit product format
553190692
Labeler code
55319
Product ID
55319-692_3f9d22a9-c28e-9158-e063-6394a90a302b
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
Dosage form
SOLUTION
Route
ORAL
Labeler
FAMILY DOLLAR SERVICES INC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-07-10
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength
650; 30; 12.5 mg/30mL; mg/30mL; mg/30mL
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA], 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Family Dollar Nighttime Cold and Flu Relief
Brand name suffix
Original Flavor
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN650 mg/30mL
DEXTROMETHORPHAN HYDROBROMIDE30 mg/30mL
DOXYLAMINE SUCCINATE12.5 mg/30mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, 9D2RTI9KYH, V9BI9B5YI2
Rxcui1043400

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
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e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-692-12Family Dollar Nighttime Cold and Flu ReliefOriginal Flavor354 mL in 1 BOTTLESOLUTION3544

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-692FAMILY DOLLAR NIGHTTIME COLD AND FLU RELIEF ORIGINAL FLAVOR (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [FAMILY DOLLAR SERVICES INC]3Current NDC, 1 package rows20241207_3f24accf-4927-4976-adb3-f1da9f6286fc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 30 mL Oral SolutionPSN3f24accf-4927-4976-adb3-f1da9f6286fc4
1043400acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSCD3f24accf-4927-4976-adb3-f1da9f6286fc4
1043400acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral SolutionSY3f24accf-4927-4976-adb3-f1da9f6286fc4
1043400acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral SolutionSY3f24accf-4927-4976-adb3-f1da9f6286fc4
1043400APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSY3f24accf-4927-4976-adb3-f1da9f6286fc4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55319-692-1255319069212354 mL in 1 BOTTLE (55319-692-12) 354 ml2023-07-10NoNoCurrent