Home NDC 55301-689 Cough and Cold HBP
Product NDC 55301-689
11-digit product format 553010689
Labeler code 55301
Product ID 55301-689_efecc969-86dd-4746-b542-381ba2082f41
Type HUMAN OTC DRUG
Nonproprietary name Chlorpheniramine maleate, Dextromethorphan HBr
Dosage form TABLET, FILM COATED
Route ORAL
Labeler ARMY AND AIR FORCE EXCHANGE SERVICE
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 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
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 55301-689-21 Cough and Cold HBP 8 in 1 BLISTER PACK TABLET, FILM COATED 8 10 55301-689-21 Cough and Cold HBP 2 in 1 CARTON TABLET, FILM COATED 2 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55301-689 COUGH AND COLD HBP (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, FILM COATED [ARMY AND AIR FORCE EXCHANGE SERVICE] 10 Current NDC, Legacy NDC, 2 package rows 20250512_ff39084f-ab2f-48ed-ac62-837f7fff2b65.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 55301-689-21 55301068921 2 BLISTER PACK in 1 CARTON (55301-689-21) / 8 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2017-05-15 0000-00-00 No No Current