Home NDC 69339-149 Guaifenesin Syrup and Dextromethorphan
Product NDC 69339-149
11-digit product format 693390149
Labeler code 69339
Product ID 69339-149_6bc4ec89-dcf0-4e03-ac41-abb85c1a5efd
Type HUMAN OTC DRUG
Nonproprietary name Guaifenesin Syrup and Dextromethorphan
Dosage form SYRUP
Route ORAL
Labeler Natco Pharma USA LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-10-19
Substance GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 100; 10 mg/5mL; mg/5mL
Pharmacologic classes Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
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 Syrup and Dextromethorphan
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GUAIFENESIN 100 mg/5mL DEXTROMETHORPHAN HYDROBROMIDE 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 9D2RTI9KYH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 996520 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 69339-149-05 Guaifenesin Syrup and Dextromethorphan 5 mL in 1 CUP, UNIT-DOSE SYRUP 5 6 69339-149-19 Guaifenesin Syrup and Dextromethorphan 10 in 1 TRAY SYRUP 10 6 69339-149-19 Guaifenesin Syrup and Dextromethorphan 10 in 1 CASE SYRUP 10 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69339-149 GUAIFENESIN SYRUP AND DEXTROMETHORPHAN SYRUP [NATCO PHARMA USA LLC] 6 Current NDC, Legacy NDC, 3 package rows 20231102_ad9026f4-f0b6-4d02-aa44-f0460eeefc0e.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 69339-149-05 69339014905 5 mL in 1 CUP, UNIT-DOSE 5 ml Historical 69339-149-19 69339014919 10 TRAY in 1 CASE (69339-149-19) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (69339-149-05) 10 tray 2020-10-19 0000-00-00 No No Current