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 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 TUSICOF
Listing expiration 2027-12-31 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 175 of 178 · 3,551 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sinus Pressure plus Pain PE ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE RETAIL BUSINESS SERVICES , LLC. eb64750f-19ac-655f-e053-2995a90a33b5 2023-11-02 Warnings Exact identifier application number: M012 Multi-Symptom Mapap Cold Formula ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL Proficient Rx LP 9bf81b26-38b4-486c-ae89-222119ce1a4f 2023-11-01 Warnings Exact identifier application number: M012 Guaifenesin Syrup and Dextromethorphan GUAIFENESIN SYRUP AND DEXTROMETHORPHAN Natco Pharma USA LLC ad9026f4-f0b6-4d02-aa44-f0460eeefc0e 2023-11-01 Warnings Exact identifier application number: M012 Diphenhydramine HCl Oral Solution DIPHENHYDRAMINE HYDROCHLORIDE Natco Pharma USA LLC 54b64354-ac10-42ff-a53d-96cef933a91a 2023-11-01 Warnings Exact identifier application number: M012 children allergy relief dye free cherry DIPHENHYDRAMINE HCL A-S Medication Solutions 5c6c1809-4c6f-4e8f-a5ae-9796e821d400 2023-11-01 Warnings Exact identifier application number: M012 Daytime and Nighttime Cherry Cold and Flu DAYTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR NIGHTTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE TARGET CORPORATION 0903b222-1a44-64aa-e063-6294a90abba0 2023-10-31 Warnings Exact identifier application number: M012 Ephrine Nose Drops PHENYLEPHRINE HYDROCHLORIDE Walgreens b620eb9f-2caf-0942-e053-2a95a90ae48e 2023-10-31 Warnings Exact identifier application number: M012 pseudoephedrine hydrochloride PSEUDOEPHEDRINE HCL A-S Medication Solutions 204849d1-ac4b-4dbe-8769-fcb30291f880 2023-10-31 Warnings Exact identifier application number: M012 Daytime Cold and Flu Relief DAYTIME COLD AND FLU RELIEF TopCo Associates, LLC d592fbb8-d4bf-444e-982e-edf6fe97dce4 2023-10-31 Warnings Exact identifier application number: M012 Nite Time Cold and Flu Relief NITE TIME COLD AND FLU RELIEF TopCo Associates, LLC 407dc4ae-882d-4a49-8884-ef048bb404cf 2023-10-31 Warnings Exact identifier application number: M012 12 Hour Original Nasal Decongestant NASAL SPRAY Sheffield Pharmaceuticals LLC cea0ce76-ae75-4484-a7c2-ff1086e9d8b0 2023-10-30 Warnings Exact identifier application number: M012 Mucosa DM DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN Magno-Humphries, Inc. 3a5533fb-1c83-4b95-9cd2-9be663d3ff5f 2023-10-27 Warnings Exact identifier application number: M012 Mucosa Guifenesin GUAIFENESIN Magno-Humphries, Inc. 9d22c208-d0ae-8b6a-e053-2995a90ab90a 2023-10-27 Warnings Exact identifier application number: M012 DG Health Cough Drops Cherry Flavor MENTHOL Dollar General Corporation c7a603d8-72fb-9626-e053-2995a90a09ea 2023-10-26 Warnings Exact identifier application number: M012 Allergy Relief 4 Hour CHLORPHENIRAMINE MALEATE Geri-Care Pharmaceutical Corp 92d90b41-0627-121e-e053-2995a90a2df1 2023-10-26 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Cherry MENTHOL Riclan S.A. 8e471265-3594-451a-8921-f0db474abe85 2023-10-26 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Eucalyptus MENTHOL Riclan S.A. 1141593a-f3ba-4adf-b332-f9fcb0b5a013 2023-10-26 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Honey Lemon MENTHOL Riclan S.A. f6271e85-9ca2-41d3-9bff-a13670ac5b80 2023-10-26 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Strawberry MENTHOL Riclan S.A. da2bbc92-7d96-4f3e-89e2-c2a9e3e4b457 2023-10-26 Warnings Exact identifier application number: M012 DG Health Cough Drops Assorted Flavors MENTHOL Dollar General Corporation c731d255-40f2-3cb3-e053-2a95a90a8877 2023-10-26 Warnings Exact identifier application number: M012
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