Home NDC 55319-692 Family Dollar Nighttime Cold and Flu Relief
Product NDC 55319-692
11-digit product format 553190692
Labeler code 55319
Product ID 55319-692_ca0a2df7-b558-45b6-83f3-997acea1c3f2
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 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 Family Dollar Nighttime Cold and Flu Relief
Brand name suffix Original Flavor
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 650 mg/30mL DEXTROMETHORPHAN HYDROBROMIDE 30 mg/30mL DOXYLAMINE SUCCINATE 12.5 mg/30mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55319-692-12 Family Dollar Nighttime Cold and Flu ReliefOriginal Flavor 354 mL in 1 BOTTLE SOLUTION 354 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55319-692 FAMILY DOLLAR NIGHTTIME COLD AND FLU RELIEF ORIGINAL FLAVOR (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [FAMILY DOLLAR SERVICES INC] 3 Current NDC, 1 package rows 20241207_3f24accf-4927-4976-adb3-f1da9f6286fc.zip
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 55319-692-12 55319069212 354 mL in 1 BOTTLE (55319-692-12) 354 ml 2023-07-10 No No Current