Home NDC 55154-5791 Guaifenesin and Codeine Phosphate
Product NDC 55154-5791
11-digit product format 551545791
Labeler code 55154
Product ID 55154-5791_54a012fb-214d-4dba-bf91-90ca8ee293c2
Type HUMAN OTC DRUG
Nonproprietary name Guaifenesin and Codeine Phosphate
Dosage form SOLUTION
Route ORAL
Labeler Cardinal Health 107, LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-06-27
Substance CODEINE PHOSPHATE; GUAIFENESIN
Active strength 10; 100 mg/5mL; mg/5mL
Pharmacologic classes Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Full Opioid Agonists [MoA], Increased Respiratory Secretions [PE], Opioid Agonist [EPC]
DEA schedule CV
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 and Codeine Phosphate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CODEINE PHOSPHATE 10 mg/5mL GUAIFENESIN 100 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination GSL05Y1MN6 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 995868 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 55154-5791-5 Guaifenesin and Codeine Phosphate 5 in 1 BAG SOLUTION 5 4 55154-5791-5 Guaifenesin and Codeine Phosphate 5 mL in 1 CUP, UNIT-DOSE SOLUTION 5 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55154-5791 GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [CARDINAL HEALTH 107, LLC] 3 Current NDC, 2 package rows 20241013_a9130f36-4761-4e6b-a383-eca3db06ea93.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 Sample Exclude flag Status 55154-5791-5 55154579105 5 CUP, UNIT-DOSE in 1 BAG (55154-5791-5) / 5 mL in 1 CUP, UNIT-DOSE 2023-06-27 No No Current