tusnel pediatric drops

Generic: 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 pediatric drops
Generic Name guaifenesin, phenylephrine hcl
Labeler llorens pharmaceuticals international division
Dosage Form SOLUTION/ DROPS
Routes
ORAL
Active Ingredients

guaifenesin 25 mg/mL, phenylephrine hydrochloride 1.25 mg/mL

Manufacturer
LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION

Identifiers & Regulatory

Product NDC 54859-605
Product ID 54859-605_47462c1c-38e8-e1af-e063-6394a90a4955
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 54859605
Hyphenated Format 54859-605

Supplemental Identifiers

RxCUI
2268063
UNII
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 drops (source: ndc)
Generic Name guaifenesin, phenylephrine hcl (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/mL
  • 1.25 mg/mL
source: ndc
Packaging
  • 30 mL in 1 BOTTLE, DROPPER (54859-605-01)
source: ndc

Packages (1)

54859-605-01 30 mL in 1 BOTTLE, DROPPER (54859-605-01)

Ingredients (2)

guaifenesin (25 mg/mL) phenylephrine hydrochloride (1.25 mg/mL)

Linked Drug Pages (1)

Tusnel Pediatric Drops ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "47462c1c-38e8-e1af-e063-6394a90a4955", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["495W7451VQ", "04JA59TNSJ"], "rxcui": ["2268063"], "spl_set_id": ["dbf7c43a-7b29-4c70-9e6d-8a7ea924a9d7"], "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 (54859-605-01)", "package_ndc": "54859-605-01", "marketing_start_date": "20190801"}], "brand_name": "Tusnel Pediatric Drops", "product_id": "54859-605_47462c1c-38e8-e1af-e063-6394a90a4955", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "54859-605", "generic_name": "Guaifenesin, Phenylephrine HCl", "labeler_name": "LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Tusnel Pediatric Drops", "active_ingredients": [{"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"}