tusnel dm pediatric

Generic: dextromethorphan, guiafenesin, pseudoephedrine hcl

Labeler: llorens pharmaceutical international division
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name tusnel dm pediatric
Generic Name dextromethorphan, guiafenesin, pseudoephedrine hcl
Labeler llorens pharmaceutical international division
Dosage Form SOLUTION/ DROPS
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 2.5 mg/mL, guaifenesin 25 mg/mL, pseudoephedrine hydrochloride 7.5 mg/mL

Manufacturer
Llorens Pharmaceutical International Division

Identifiers & Regulatory

Product NDC 54859-603
Product ID 54859-603_47463023-1b8c-729b-e063-6394a90a8dce
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 1993-01-01

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 54859603
Hyphenated Format 54859-603

Supplemental Identifiers

RxCUI
1241674
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 dm pediatric (source: ndc)
Generic Name dextromethorphan, guiafenesin, pseudoephedrine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/mL
  • 25 mg/mL
  • 7.5 mg/mL
source: ndc
Packaging
  • 60 mL in 1 BOTTLE, DROPPER (54859-603-02)
source: ndc

Packages (1)

54859-603-02 60 mL in 1 BOTTLE, DROPPER (54859-603-02)

Ingredients (3)

dextromethorphan hydrobromide (2.5 mg/mL) guaifenesin (25 mg/mL) pseudoephedrine hydrochloride (7.5 mg/mL)

Linked Drug Pages (1)

Tusnel DM Pediatric ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "47463023-1b8c-729b-e063-6394a90a8dce", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ", "6V9V2RYJ8N"], "rxcui": ["1241674"], "spl_set_id": ["d915eab8-013e-4ce3-b358-0d531e5ca1ba"], "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": "60 mL in 1 BOTTLE, DROPPER (54859-603-02)", "package_ndc": "54859-603-02", "marketing_start_date": "19930101"}], "brand_name": "Tusnel DM Pediatric", "product_id": "54859-603_47463023-1b8c-729b-e063-6394a90a8dce", "dosage_form": "SOLUTION/ DROPS", "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": "54859-603", "generic_name": "Dextromethorphan, Guiafenesin, Pseudoephedrine HCl", "labeler_name": "Llorens Pharmaceutical International Division", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Tusnel DM", "brand_name_suffix": "Pediatric", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "2.5 mg/mL"}, {"name": "GUAIFENESIN", "strength": "25 mg/mL"}, {"name": "PSEUDOEPHEDRINE HYDROCHLORIDE", "strength": "7.5 mg/mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "19930101", "listing_expiration_date": "20261231"}