Home NDC 54859-508 Triponel
Product NDC 54859-508
11-digit product format 548590508
Labeler code 54859
Product ID 54859-508_47461d04-60e6-bfde-e063-6394a90aaeec
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan HBr, Phenylephrine HCl, Triprolidine HCl
Dosage form LIQUID
Route ORAL
Labeler LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-08-01
Substance DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE
Active strength 15; 5; 1.25 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], 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]
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 Triponel
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 15 mg/5mL PHENYLEPHRINE HYDROCHLORIDE 5 mg/5mL TRIPROLIDINE HYDROCHLORIDE 1.25 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9D2RTI9KYH Internal UNII lookup 04JA59TNSJ Internal UNII lookup YAN7R5L890 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2268058 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 54859-508-16 Triponel 474 mL in 1 BOTTLE LIQUID 474 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54859-508 TRIPONEL (DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCL) LIQUID [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION] 2 Current NDC, Legacy NDC, 1 package rows 20241222_cc774d33-96ce-4992-ad30-3cb03b0d119d.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 123 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 54859-508-16 54859050816 474 mL in 1 BOTTLE (54859-508-16) 474 ml 2019-08-01 0000-00-00 No No Current