g-tusicof

Generic: dextromethorphan, guaifenesin, and phenylephrine

Labeler: kramer novis
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name g-tusicof
Generic Name dextromethorphan, guaifenesin, and phenylephrine
Labeler kramer novis
Dosage Form SYRUP
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 20 mg/5mL, guaifenesin 400 mg/5mL, phenylephrine hydrochloride 10 mg/5mL

Manufacturer
Kramer Novis

Identifiers & Regulatory

Product NDC 52083-639
Product ID 52083-639_8964ce40-2db3-43b6-9c4c-126dbe0425a2
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2012-09-24

Pharmacologic Class

Established (EPC)
expectorant [epc]
Physiologic Effect
decreased respiratory secretion viscosity [pe] increased respiratory secretions [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 52083639
Hyphenated Format 52083-639

Supplemental Identifiers

RxCUI
1091331
UNII
9D2RTI9KYH 495W7451VQ 04JA59TNSJ
NUI
N0000193956 N0000008867 N0000009560

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name g-tusicof (source: ndc)
Generic Name dextromethorphan, guaifenesin, and phenylephrine (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/5mL
  • 400 mg/5mL
  • 10 mg/5mL
source: ndc
Packaging
  • 474 mL in 1 BOTTLE (52083-639-16)
source: ndc

Packages (1)

52083-639-16 474 mL in 1 BOTTLE (52083-639-16)

Ingredients (3)

dextromethorphan hydrobromide (20 mg/5mL) guaifenesin (400 mg/5mL) phenylephrine hydrochloride (10 mg/5mL)

Linked Drug Pages (1)

G-TUSICOF ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8964ce40-2db3-43b6-9c4c-126dbe0425a2", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1091331"], "spl_set_id": ["d169585f-b4f4-4831-8c71-e1533ae7e7c4"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Kramer Novis"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "474 mL in 1 BOTTLE (52083-639-16)", "package_ndc": "52083-639-16", "marketing_start_date": "20191113"}], "brand_name": "G-TUSICOF", "product_id": "52083-639_8964ce40-2db3-43b6-9c4c-126dbe0425a2", "dosage_form": "SYRUP", "pharm_class": ["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]"], "product_ndc": "52083-639", "generic_name": "dextromethorphan, guaifenesin, and phenylephrine", "labeler_name": "Kramer Novis", "product_type": "HUMAN OTC DRUG", "brand_name_base": "G-TUSICOF", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/5mL"}, {"name": "GUAIFENESIN", "strength": "400 mg/5mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20120924", "listing_expiration_date": "20261231"}