Home NDC 83324-072 Cough and Cold HBP
Product NDC 83324-072
11-digit product format 833240072
Labeler code 83324
Product ID 83324-072_4912146b-4f66-4387-966c-0440eaf77209
Type HUMAN OTC DRUG
Nonproprietary name Chlorpheniramine maleate, Dextromethorphan HBr
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Chain Drug Marketing Association, Inc.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-07-03
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 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 Cough and Cold HBP
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CHLORPHENIRAMINE MALEATE 4 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 30 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83324-072-16 Cough and Cold HBP 8 in 1 BLISTER PACK TABLET, FILM COATED 8 4 83324-072-16 Cough and Cold HBP 2 in 1 CARTON TABLET, FILM COATED 2 4 83324-072-24 Cough and Cold HBP 3 in 1 CARTON TABLET, FILM COATED 3 4 83324-072-24 Cough and Cold HBP 8 in 1 BLISTER PACK TABLET, FILM COATED 8 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83324-072 COUGH AND COLD HBP (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION, INC.] 3 Current NDC, 4 package rows 20241017_b00ec380-4e6e-4a3b-958c-50c75cff81a0.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 99 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 83324-072-16 83324007216 2 BLISTER PACK in 1 CARTON (83324-072-16) / 8 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2024-07-03 No No Current 83324-072-24 83324007224 3 BLISTER PACK in 1 CARTON (83324-072-24) / 8 TABLET, FILM COATED in 1 BLISTER PACK 3 blister pack 2024-07-03 No No Current