Home NDC 50844-689 Cough and Cold HBP
Product NDC 50844-689
11-digit product format 508440689
Labeler code 50844
Product ID 50844-689_eda8099c-cbbf-4aa3-9142-fbb7a700901b
Type HUMAN OTC DRUG
Nonproprietary name Chlorpheniramine maleate, Dextromethorphan HBr
Dosage form TABLET, FILM COATED
Route ORAL
Labeler L.N.K. International, Inc.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2017-05-15
Substance CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 4; 30 mg/1; mg/1
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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 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 Cough and Cold HBP
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CHLORPHENIRAMINE MALEATE 4 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 30 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V1Q0O9OJ9Z Internal UNII lookup 9D2RTI9KYH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1421985 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 50844-689-21 Cough and Cold HBP 2 in 1 CARTON TABLET, FILM COATED 2 12 50844-689-21 Cough and Cold HBP 8 in 1 BLISTER PACK TABLET, FILM COATED 8 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50844-689 COUGH AND COLD HBP (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.] 10 Current NDC, Legacy NDC, 2 package rows 20240921_9f2daffc-1904-4d64-9f84-689c88601e06.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 50844-689-21 50844068921 2 BLISTER PACK in 1 CARTON (50844-689-21) / 8 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2017-05-15 0000-00-00 No No Current