Home NDC 55910-533 Chest Congestion Relief DM
Product NDC 55910-533
11-digit product format 559100533
Labeler code 55910
Product ID 55910-533_9bf8ca4c-806f-4dd6-8171-19143075a6ce
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan HBr, Guaifenesin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler DOLGENCORP, LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-05-10
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength 20; 400 mg/1; mg/1
Pharmacologic classes Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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 Chest Congestion Relief DM
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 20 mg/1 GUAIFENESIN 400 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9D2RTI9KYH Internal UNII lookup 495W7451VQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1147685 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 55910-533-01 Chest Congestion Relief DM 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 4 55910-533-01 Chest Congestion Relief DM 1 in 1 CARTON TABLET, FILM COATED 1 4 55910-533-11 Chest Congestion Relief DM 1 in 1 CARTON TABLET, FILM COATED 1 4 55910-533-11 Chest Congestion Relief DM 60 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 60 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55910-533 CHEST CONGESTION RELIEF DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) TABLET, FILM COATED [DOLGENCORP, LLC] 3 Current NDC, 4 package rows 20250512_da053bc3-e790-4ae9-a406-2629640e97e7.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 97 of 178 · 3,551 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 55910-533-01 55910053301 1 BOTTLE, PLASTIC in 1 CARTON (55910-533-01) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2024-05-10 No No Current 55910-533-11 55910053311 1 BOTTLE, PLASTIC in 1 CARTON (55910-533-11) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2024-05-10 No No Current