Home NDC 52083-239 TUSICOF
Product NDC 52083-239
11-digit product format 520830239
Labeler code 52083
Product ID 52083-239_e954ebb2-df25-40bf-b068-8ac861d6677b
Type HUMAN OTC DRUG
Nonproprietary name dextromethorphan, guaifenesin, and phenylephrine
Dosage form SYRUP
Route ORAL
Labeler Kramer Novis
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2010-08-17
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 20; 400; 10 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], 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], alpha-1 Adrenergic Agonist [EPC]
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 TUSICOF
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 20 mg/5mL GUAIFENESIN 400 mg/5mL PHENYLEPHRINE HYDROCHLORIDE 10 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9D2RTI9KYH Internal UNII lookup 495W7451VQ Internal UNII lookup 04JA59TNSJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1091331 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 52083-239-01 TUSICOF 30 mL in 1 BOTTLE SYRUP 30 7 52083-239-04 TUSICOF 120 mL in 1 BOTTLE SYRUP 120 7 52083-239-16 TUSICOF 474 mL in 1 BOTTLE SYRUP 474 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH TUSICOF (DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE) SYRUP [KRAMER NOVIS] 3 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ TUSICOF (DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE) SYRUP [KRAMER NOVIS] 3 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ TUSICOF (DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE) SYRUP [KRAMER NOVIS] 3 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS TUSICOF (DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE) SYRUP [KRAMER NOVIS] 3 GUAIFENESIN ACTIVE MOIETY 495W7451VQ TUSICOF (DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE) SYRUP [KRAMER NOVIS] 3 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV TUSICOF (DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE) SYRUP [KRAMER NOVIS] 3 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP TUSICOF (DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE) SYRUP [KRAMER NOVIS] 3 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX TUSICOF (DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE) SYRUP [KRAMER NOVIS] 3 MENTHOL INACTIVE INGREDIENT L7T10EIP3A TUSICOF (DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE) SYRUP [KRAMER NOVIS] 3 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T TUSICOF (DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE) SYRUP [KRAMER NOVIS] 3 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A TUSICOF (DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE) SYRUP [KRAMER NOVIS] 3 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH TUSICOF (DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE) SYRUP [KRAMER NOVIS] 3 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR TUSICOF (DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE) SYRUP [KRAMER NOVIS] 3 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 TUSICOF (DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE) SYRUP [KRAMER NOVIS] 3 WATER INACTIVE INGREDIENT 059QF0KO0R TUSICOF (DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE) SYRUP [KRAMER NOVIS] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52083-239 TUSICOF (DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE) SYRUP [KRAMER NOVIS] 6 Current NDC, Legacy NDC, 3 package rows 20241011_e966b75c-4bb4-4216-8247-baada8f5d759.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 52083-239-01 52083023901 30 mL in 1 BOTTLE (52083-239-01) 30 ml 2010-08-17 0000-00-00 No No Current 52083-239-04 52083023904 120 mL in 1 BOTTLE (52083-239-04) 120 ml 2010-08-17 0000-00-00 No No Current 52083-239-16 52083023916 474 mL in 1 BOTTLE (52083-239-16) 474 ml 2012-10-08 0000-00-00 No No Current