Home NDC 69367-272 Codeine-Guaifenesin
Product NDC 69367-272
11-digit product format 693670272
Labeler code 69367
Product ID 69367-272_447eca2f-cbca-4ae6-bcd9-dfac47105319
Type HUMAN OTC DRUG
Nonproprietary name Codeine Phosphate and Guaifenesin
Dosage form SOLUTION
Route ORAL
Labeler Westminster Pharmaceuticals, LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-07-15
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 Codeine-Guaifenesin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CODEINE PHOSPHATE 10 mg/5mL GUAIFENESIN 100 mg/5mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69367-272-04 Codeine-Guaifenesin 118 mL in 1 BOTTLE SOLUTION 118 6 69367-272-16 Codeine-Guaifenesin 473 mL in 1 BOTTLE SOLUTION 473 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69367-272 CODEINE-GUAIFENESIN (CODEINE PHOSPHATE AND GUAIFENESIN) SOLUTION [WESTMINSTER PHARMACEUTICALS, LLC] 6 Current NDC, Legacy NDC, 2 package rows 20250515_3da3efd7-e278-4d79-9130-eef3992097e4.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 74 of 180 · 3,583 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 69367-272-04 69367027204 118 mL in 1 BOTTLE (69367-272-04) 118 ml 2020-07-15 0000-00-00 No No Current 69367-272-16 69367027216 473 mL in 1 BOTTLE (69367-272-16) 473 ml 2020-07-15 0000-00-00 No No Current