Home NDC 55154-5785 GUAIFENESIN DM
Product NDC 55154-5785
11-digit product format 551545785
Labeler code 55154
Product ID 55154-5785_fc55eac0-ec3d-4788-aa04-e792c52ff620
Type HUMAN OTC DRUG
Nonproprietary name GUAIFENESIN and DEXTROMETHORPHAN
Dosage form SYRUP
Route ORAL
Labeler Cardinal Health 107, LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 1992-07-01
Substance GUAIFENESIN; DEXTROMETHORPHAN
Active strength 100; 10 mg/5mL; mg/5mL
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 GUAIFENESIN DM
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GUAIFENESIN 100 mg/5mL DEXTROMETHORPHAN 10 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 495W7451VQ Internal UNII lookup 7355X3ROTS Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 996520 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 55154-5785-5 GUAIFENESIN DM 5 in 1 BAG SYRUP 5 8 55154-5785-5 GUAIFENESIN DM 5 mL in 1 CUP, UNIT-DOSE SYRUP 5 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55154-5785 GUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SYRUP [CARDINAL HEALTH 107, LLC] 5 Current NDC, Legacy NDC, 2 package rows 20240117_9cfb1abb-98c4-4e90-8dd7-fcffc112f988.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 Marketing start Marketing end Sample Exclude flag Status 55154-5785-5 55154578505 5 CUP, UNIT-DOSE in 1 BAG (55154-5785-5) / 5 mL in 1 CUP, UNIT-DOSE 1992-07-01 0000-00-00 No No Current