Home NDC 54859-605 Tusnel Pediatric Drops
Product NDC 54859-605
11-digit product format 548590605
Labeler code 54859
Product ID 54859-605_47462c1c-38e8-e1af-e063-6394a90a4955
Type HUMAN OTC DRUG
Nonproprietary name Guaifenesin, Phenylephrine HCl
Dosage form SOLUTION/ DROPS
Route ORAL
Labeler LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-08-01
Substance GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 25; 1.25 mg/mL; mg/mL
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Tusnel Pediatric Drops
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GUAIFENESIN 25 mg/mL PHENYLEPHRINE HYDROCHLORIDE 1.25 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 495W7451VQ Internal UNII lookup 04JA59TNSJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2268063 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 54859-605-01 Tusnel Pediatric Drops 30 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 30 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54859-605 TUSNEL PEDIATRIC DROPS (GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION/ DROPS [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION] 3 Current NDC, Legacy NDC, 1 package rows 20241222_dbf7c43a-7b29-4c70-9e6d-8a7ea924a9d7.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 74 of 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 54859-605-01 54859060501 30 mL in 1 BOTTLE, DROPPER (54859-605-01) 30 ml 2019-08-01 0000-00-00 No No Current