tusnel-dm pediatric

Generic: dextromethorphan hbr, guaifenesin, phenylephrine hcl

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

Drug Facts

Product Profile

Brand Name tusnel-dm pediatric
Generic Name dextromethorphan hbr, guaifenesin, phenylephrine hcl
Labeler llorens pharmaceuticals international division
Dosage Form SOLUTION/ DROPS
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 2.5 mg/mL, guaifenesin 25 mg/mL, phenylephrine hydrochloride 1.25 mg/mL

Manufacturer
LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION

Identifiers & Regulatory

Product NDC 54859-606
Product ID 54859-606_47463023-1b8d-729b-e063-6394a90a8dce
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2019-08-01

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 54859606
Hyphenated Format 54859-606

Supplemental Identifiers

RxCUI
2268062
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-dm pediatric (source: ndc)
Generic Name dextromethorphan hbr, guaifenesin, phenylephrine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2.5 mg/mL
  • 25 mg/mL
  • 1.25 mg/mL
source: ndc
Packaging
  • 30 mL in 1 BOTTLE, DROPPER (54859-606-01)
source: ndc

Packages (1)

54859-606-01 30 mL in 1 BOTTLE, DROPPER (54859-606-01)

Ingredients (3)

dextromethorphan hydrobromide (2.5 mg/mL) guaifenesin (25 mg/mL) phenylephrine hydrochloride (1.25 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": "47463023-1b8d-729b-e063-6394a90a8dce", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["2268062"], "spl_set_id": ["64e36b02-b5be-4d20-8818-cb5b23596671"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 mL in 1 BOTTLE, DROPPER (54859-606-01)", "package_ndc": "54859-606-01", "marketing_start_date": "20190801"}], "brand_name": "Tusnel-DM Pediatric", "product_id": "54859-606_47463023-1b8d-729b-e063-6394a90a8dce", "dosage_form": "SOLUTION/ DROPS", "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": "54859-606", "generic_name": "Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl", "labeler_name": "LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Tusnel-DM Pediatric", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "2.5 mg/mL"}, {"name": "GUAIFENESIN", "strength": "25 mg/mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "1.25 mg/mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20190801", "listing_expiration_date": "20261231"}