Home NDC 55910-689 Cough and Cold HBP
Product NDC 55910-689
11-digit product format 559100689
Labeler code 55910
Product ID 55910-689_94400fe6-aa11-417b-9f16-a1cf9380bd16
Type HUMAN OTC DRUG
Nonproprietary name Chlorpheniramine Maleate, Dextromethorphan HBr
Dosage form TABLET, FILM COATED
Route ORAL
Labeler DOLGENCORP, LLC
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 55910-689-21 Cough and Cold HBP 2 in 1 CARTON TABLET, FILM COATED 2 12 55910-689-21 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 55910-689 COUGH AND COLD HBP (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, COATED [DOLGENCORP, LLC] 11 Current NDC, Legacy NDC, 2 package rows 20240824_7a662caf-9cbb-4d55-b0b2-43f1f1289ec7.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 73 of 178 · 3,551 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 55910-689-21 55910068921 2 BLISTER PACK in 1 CARTON (55910-689-21) / 8 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2017-05-15 0000-00-00 No No Current