Home NDC 50844-677 Cold and Flu Nighttime Severe
Product NDC 50844-677
11-digit product format 508440677
Labeler code 50844
Product ID 50844-677_49a8cfc8-1fce-48bc-94a0-c4ed3f989b20
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler L.N.K. International, Inc.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-02-07
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325; 10; 6.25; 5 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], 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], alpha-1 Adrenergic Agonist [EPC]
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 Cold and Flu Nighttime Severe
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1 DOXYLAMINE SUCCINATE 6.25 mg/1 PHENYLEPHRINE HYDROCHLORIDE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1546881 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 50844-677-21 Cold and Flu Nighttime Severe 8 in 1 BLISTER PACK TABLET, FILM COATED 8 6 50844-677-21 Cold and Flu Nighttime Severe 2 in 1 CARTON TABLET, FILM COATED 2 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50844-677 COLD AND FLU NIGHTTIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.] 5 Current NDC, Legacy NDC, 2 package rows 20240623_9167a80e-fcf0-4b64-97e6-8a8ac566f134.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 Marketing end Sample Exclude flag Status 50844-677-21 50844067721 2 BLISTER PACK in 1 CARTON (50844-677-21) / 8 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2022-02-07 0000-00-00 No No Current