Home NDC 52083-400 ZYNCOF
Product NDC 52083-400
11-digit product format 520830400
Labeler code 52083
Product ID 52083-400_7e831d13-64c5-4ee2-a290-d1d93ceec80f
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan HBr and Guaifenesin
Dosage form SYRUP
Route ORAL
Labeler Kramer Novis
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2011-06-01
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength 20; 400 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 ZYNCOF
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 20 mg/5mL GUAIFENESIN 400 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9D2RTI9KYH 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 1113368 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 52083-400-01 ZYNCOF 30 mL in 1 BOTTLE, PLASTIC SYRUP 30 6 52083-400-04 ZYNCOF 120 mL in 1 BOTTLE, PLASTIC SYRUP 120 6 52083-400-16 ZYNCOF 474 mL in 1 BOTTLE, PLASTIC SYRUP 474 6
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52083-400 ZYNCOF (DEXTROMETHORPHAN HBR AND GUAIFENESIN) SYRUP [KRAMER NOVIS] 5 Current NDC, Legacy NDC, 3 package rows 20241012_cffd6d5f-0cb2-4d38-bdb0-6a21120418cc.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 98 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 52083-400-01 52083040001 30 mL in 1 BOTTLE, PLASTIC (52083-400-01) 30 ml 2011-06-01 0000-00-00 No No Current 52083-400-04 52083040004 120 mL in 1 BOTTLE, PLASTIC (52083-400-04) 120 ml 2011-06-01 0000-00-00 No No Current 52083-400-16 52083040016 474 mL in 1 BOTTLE, PLASTIC (52083-400-16) 474 ml 2013-01-23 0000-00-00 No No Current