tusnel pediatric dm

Generic: dextromethorphan hbr, guaifenesin, phenylephrine hcl

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

Drug Facts

Product Profile

Brand Name tusnel pediatric dm
Generic Name dextromethorphan hbr, guaifenesin, phenylephrine hcl
Labeler llorens pharmaceutical international division, inc.
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 5 mg/5mL, guaifenesin 75 mg/5mL, phenylephrine hydrochloride 2.5 mg/5mL

Manufacturer
Llorens Pharmaceutical International Division, Inc.

Identifiers & Regulatory

Product NDC 54859-604
Product ID 54859-604_474629aa-619b-cf58-e063-6394a90abc92
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2019-05-01

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 54859604
Hyphenated Format 54859-604

Supplemental Identifiers

RxCUI
1119541
UPC
0354859604163
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 tusnel pediatric dm (source: ndc)
Generic Name dextromethorphan hbr, guaifenesin, phenylephrine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/5mL
  • 75 mg/5mL
  • 2.5 mg/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (54859-604-16)
source: ndc

Packages (1)

54859-604-16 473 mL in 1 BOTTLE (54859-604-16)

Ingredients (3)

dextromethorphan hydrobromide (5 mg/5mL) guaifenesin (75 mg/5mL) phenylephrine hydrochloride (2.5 mg/5mL)

Linked Drug Pages (1)

Tusnel Pediatric DM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "474629aa-619b-cf58-e063-6394a90abc92", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0354859604163"], "unii": ["9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1119541"], "spl_set_id": ["63541753-de8d-42fe-a9b3-a5eac3fcdca4"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Llorens Pharmaceutical International Division, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (54859-604-16)", "package_ndc": "54859-604-16", "marketing_start_date": "20190501"}], "brand_name": "Tusnel Pediatric DM", "product_id": "54859-604_474629aa-619b-cf58-e063-6394a90abc92", "dosage_form": "LIQUID", "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": "54859-604", "generic_name": "Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl", "labeler_name": "Llorens Pharmaceutical International Division, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Tusnel Pediatric", "brand_name_suffix": "DM", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "5 mg/5mL"}, {"name": "GUAIFENESIN", "strength": "75 mg/5mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "2.5 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20190501", "listing_expiration_date": "20261231"}