Home NDC 55319-968 Nighttime Cold and Flu Relief
Product NDC 55319-968
11-digit product format 553190968
Labeler code 55319
Product ID 55319-968_cebc5823-181f-43d2-8c3f-ef874ea6b5f9
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Family Dollar (FAMILY WELLNESS)
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-07-01
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength 325; 15; 6.25 mg/1; mg/1; mg/1
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 Nighttime Cold and Flu Relief
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1 DOXYLAMINE SUCCINATE 6.25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup 9D2RTI9KYH Internal UNII lookup V9BI9B5YI2 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1094549 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 55319-968-08 Nighttime Cold and Flu Relief 1 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 1 7 55319-968-08 Nighttime Cold and Flu Relief 8 in 1 CARTON CAPSULE, LIQUID FILLED 8 7 55319-968-16 Nighttime Cold and Flu Relief 16 in 1 CARTON CAPSULE, LIQUID FILLED 16 7 55319-968-16 Nighttime Cold and Flu Relief 1 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 1 7 55319-968-24 Nighttime Cold and Flu Relief 24 in 1 CARTON CAPSULE, LIQUID FILLED 24 7 55319-968-24 Nighttime Cold and Flu Relief 1 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55319-968 NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [FAMILY DOLLAR (FAMILY WELLNESS)] 5 Current NDC, 6 package rows 20240328_2c431220-c61b-4ad5-9ad2-58ccaee2d1c3.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 55319-968-08 55319096808 8 BLISTER PACK in 1 CARTON (55319-968-08) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 8 blister pack 2023-07-01 No No Current 55319-968-16 55319096816 16 BLISTER PACK in 1 CARTON (55319-968-16) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 16 blister pack 2023-07-01 No No Current 55319-968-24 55319096824 24 BLISTER PACK in 1 CARTON (55319-968-24) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 24 blister pack 2023-07-01 No No Current