tusnel pediatric (54859-544)

Drug Facts

Product Profile

Brand Name tusnel pediatric

Generic Name dextromethorphan, guiafenesin, pseudoephedrine hcl

Labeler llorens pharmaceutical international division

Dosage Form LIQUID

Routes

ORAL

Active Ingredients

dextromethorphan hydrobromide 5 mg/5mL, guaifenesin 50 mg/5mL, pseudoephedrine hydrochloride 15 mg/5mL

Manufacturer

Llorens Pharmaceutical International Division

Identifiers & Regulatory

Product NDC 54859-544

Product ID 54859-544_47461ad3-a121-2a11-e063-6294a90a0f8f

Product Type HUMAN OTC DRUG

Marketing Category OTC MONOGRAPH DRUG

Application Number M012

Listing Expiration 2026-12-31

Marketing Start 2006-01-01

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 54859544

Hyphenated Format 54859-544

Supplemental Identifiers

RxCUI

1098911

UPC

0054859544161

UNII

9D2RTI9KYH 495W7451VQ 6V9V2RYJ8N

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 tusnel pediatric (source: ndc)

Generic Name dextromethorphan, guiafenesin, pseudoephedrine hcl (source: ndc)

Application Number M012 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

5 mg/5mL
50 mg/5mL
15 mg/5mL

source: ndc

Packaging

118 mL in 1 BOTTLE (54859-544-04)
473 mL in 1 BOTTLE (54859-544-16)

source: ndc

Packages (2)

54859-544-04 118 mL in 1 BOTTLE (54859-544-04) 54859-544-16 473 mL in 1 BOTTLE (54859-544-16)

Ingredients (3)

dextromethorphan hydrobromide (5 mg/5mL) guaifenesin (50 mg/5mL) pseudoephedrine hydrochloride (15 mg/5mL)

Linked Drug Pages (1)

Tusnel Pediatric ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "47461ad3-a121-2a11-e063-6294a90a0f8f", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0054859544161"], "unii": ["9D2RTI9KYH", "495W7451VQ", "6V9V2RYJ8N"], "rxcui": ["1098911"], "spl_set_id": ["82f447f6-4f1b-4f56-9d7d-ea02adeea88c"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Llorens Pharmaceutical International Division"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE (54859-544-04)", "package_ndc": "54859-544-04", "marketing_start_date": "20060101"}, {"sample": false, "description": "473 mL in 1 BOTTLE (54859-544-16)", "package_ndc": "54859-544-16", "marketing_start_date": "20060101"}], "brand_name": "Tusnel Pediatric", "product_id": "54859-544_47461ad3-a121-2a11-e063-6294a90a0f8f", "dosage_form": "LIQUID", "pharm_class": ["Adrenergic alpha-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-Adrenergic Agonist [EPC]"], "product_ndc": "54859-544", "generic_name": "Dextromethorphan, Guiafenesin, Pseudoephedrine HCl", "labeler_name": "Llorens Pharmaceutical International Division", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Tusnel", "brand_name_suffix": "Pediatric", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "5 mg/5mL"}, {"name": "GUAIFENESIN", "strength": "50 mg/5mL"}, {"name": "PSEUDOEPHEDRINE HYDROCHLORIDE", "strength": "15 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20060101", "listing_expiration_date": "20261231"}