Home NDC 0121-1550 Guaifenesin and Codeine Phosphate
Product NDC 0121-1550
11-digit product format 001211550
Labeler code 0121
Product ID 0121-1550_2175415b-f07e-50a6-e063-6394a90acabe
Type HUMAN OTC DRUG
Nonproprietary name Guaifenesin and Codeine Phosphate
Dosage form SOLUTION
Route ORAL
Labeler PAI Holdings, LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2006-10-01
Substance GUAIFENESIN; CODEINE PHOSPHATE
Active strength 200; 20 mg/10mL; mg/10mL
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 200 mg/10mL CODEINE PHOSPHATE 20 mg/10mL
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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0121-1550-00 Guaifenesin and Codeine Phosphate 10 in 1 TRAY SOLUTION 10 11 0121-1550-00 Guaifenesin and Codeine Phosphate 10 in 1 CASE SOLUTION 10 11 0121-1550-10 Guaifenesin and Codeine Phosphate 10 mL in 1 CUP, UNIT-DOSE SOLUTION 10 11 0121-1550-40 Guaifenesin and Codeine Phosphate 10 in 1 TRAY SOLUTION 10 11 0121-1550-40 Guaifenesin and Codeine Phosphate 4 in 1 CASE SOLUTION 4 11
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0121-1550 GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [PAI HOLDINGS, LLC] 11 Current NDC, Legacy NDC, 5 package rows 20240907_88d0994c-4270-4408-8837-bd97510b2118.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 177 · 3,534 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0121-1550-00 00121155000 10 TRAY in 1 CASE (0121-1550-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-1550-10) 10 tray 2006-10-01 0000-00-00 No No Current 0121-1550-10 00121155010 10 mL in 1 CUP, UNIT-DOSE 10 ml Historical 0121-1550-40 00121155040 4 TRAY in 1 CASE (0121-1550-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-1550-10) 4 tray 2024-01-10 No No Current