Home NDC 55154-9450 GUAIFENESIN
Product NDC 55154-9450
11-digit product format 551549450
Labeler code 55154
Product ID 55154-9450_39be0662-6709-447d-977f-8ab2af20c742
Type HUMAN OTC DRUG
Nonproprietary name GUAIFENESIN
Dosage form SOLUTION
Route ORAL
Labeler Cardinal Health 107, LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2002-09-01
Substance GUAIFENESIN
Active strength 100 mg/5mL
Pharmacologic classes Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
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
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GUAIFENESIN 100 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 310604 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 55154-9450-5 GUAIFENESIN 5 mL in 1 CUP, UNIT-DOSE SOLUTION 5 10 55154-9450-5 GUAIFENESIN 5 in 1 BAG SOLUTION 5 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55154-9450 GUAIFENESIN SOLUTION [CARDINAL HEALTH 107, LLC] 8 Current NDC, Legacy NDC, 2 package rows 20240112_888b6a2e-6631-4585-a7fe-eb122eb51b23.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 177 · 3,534 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 55154-9450-5 55154945005 5 CUP, UNIT-DOSE in 1 BAG (55154-9450-5) / 5 mL in 1 CUP, UNIT-DOSE 2002-09-01 0000-00-00 No No Current