Home NDC 68788-8361 Guaifenesin and Codeine Phosphate
Product NDC 68788-8361
11-digit product format 687888361
Labeler code 68788
Product ID 68788-8361_09ad5feb-c680-4634-8790-ab23bf0b8336
Type HUMAN OTC DRUG
Nonproprietary name Guaifenesin and Codeine Phosphate
Dosage form SOLUTION
Route ORAL
Labeler Preferred Pharmaceuticals Inc.
Application MO12
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-02-01
Substance GUAIFENESIN; CODEINE PHOSPHATE
Active strength 100; 10 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 2026-12-31
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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GUAIFENESIN 100 mg/5mL CODEINE PHOSPHATE 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 GSL05Y1MN6 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 68788-8361-1 Guaifenesin and Codeine Phosphate 118 mL in 1 BOTTLE SOLUTION 118 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68788-8361 GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [PREFERRED PHARMACEUTICALS INC.] 2 Current NDC, 1 package rows 20240517_f5265ae5-db8e-428d-90e9-5eda6a8a22bd.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 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68788-8361-1 68788836101 118 mL in 1 BOTTLE (68788-8361-1) 118 ml 2023-02-01 No No Current