Home NDC 54859-509 Tusnel Cough Suppressant Expectorant
Product NDC 54859-509
11-digit product format 548590509
Labeler code 54859
Product ID 54859-509_4746270d-593c-472a-e063-6294a90ace21
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan HBr, Guaifenesin
Dosage form LIQUID
Route ORAL
Labeler Llorens Pharmaceutical International Division, Inc.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-05-01
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength 10; 100 mg/5mL; mg/5mL
Pharmacologic classes 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]
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 Cough Suppressant Expectorant
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 10 mg/5mL GUAIFENESIN 100 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9D2RTI9KYH Internal UNII lookup 495W7451VQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 996520 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 54859-509-16 Tusnel Cough Suppressant Expectorant 473 mL in 1 BOTTLE LIQUID 473 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54859-509 TUSNEL COUGH SUPPRESSANT EXPECTORANT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION, INC.] 2 Current NDC, Legacy NDC, 1 package rows 20241222_af71cdbc-33d6-4303-b494-d7321721d3be.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 175 of 178 · 3,550 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Multi-Symptom Mapap Cold Formula ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL Proficient Rx LP 9bf81b26-38b4-486c-ae89-222119ce1a4f 2023-11-01 Warnings Exact identifier application number: M012 Guaifenesin Syrup and Dextromethorphan GUAIFENESIN SYRUP AND DEXTROMETHORPHAN Natco Pharma USA LLC ad9026f4-f0b6-4d02-aa44-f0460eeefc0e 2023-11-01 Warnings Exact identifier application number: M012 Diphenhydramine HCl Oral Solution DIPHENHYDRAMINE HYDROCHLORIDE Natco Pharma USA LLC 54b64354-ac10-42ff-a53d-96cef933a91a 2023-11-01 Warnings Exact identifier application number: M012 children allergy relief dye free cherry DIPHENHYDRAMINE HCL A-S Medication Solutions 5c6c1809-4c6f-4e8f-a5ae-9796e821d400 2023-11-01 Warnings Exact identifier application number: M012 Daytime and Nighttime Cherry Cold and Flu DAYTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR NIGHTTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE TARGET CORPORATION 0903b222-1a44-64aa-e063-6294a90abba0 2023-10-31 Warnings Exact identifier application number: M012 Ephrine Nose Drops PHENYLEPHRINE HYDROCHLORIDE Walgreens b620eb9f-2caf-0942-e053-2a95a90ae48e 2023-10-31 Warnings Exact identifier application number: M012 pseudoephedrine hydrochloride PSEUDOEPHEDRINE HCL A-S Medication Solutions 204849d1-ac4b-4dbe-8769-fcb30291f880 2023-10-31 Warnings Exact identifier application number: M012 Daytime Cold and Flu Relief DAYTIME COLD AND FLU RELIEF TopCo Associates, LLC d592fbb8-d4bf-444e-982e-edf6fe97dce4 2023-10-31 Warnings Exact identifier application number: M012 Nite Time Cold and Flu Relief NITE TIME COLD AND FLU RELIEF TopCo Associates, LLC 407dc4ae-882d-4a49-8884-ef048bb404cf 2023-10-31 Warnings Exact identifier application number: M012 12 Hour Original Nasal Decongestant NASAL SPRAY Sheffield Pharmaceuticals LLC cea0ce76-ae75-4484-a7c2-ff1086e9d8b0 2023-10-30 Warnings Exact identifier application number: M012 Mucosa DM DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN Magno-Humphries, Inc. 3a5533fb-1c83-4b95-9cd2-9be663d3ff5f 2023-10-27 Warnings Exact identifier application number: M012 Mucosa Guifenesin GUAIFENESIN Magno-Humphries, Inc. 9d22c208-d0ae-8b6a-e053-2995a90ab90a 2023-10-27 Warnings Exact identifier application number: M012 DG Health Cough Drops Cherry Flavor MENTHOL Dollar General Corporation c7a603d8-72fb-9626-e053-2995a90a09ea 2023-10-26 Warnings Exact identifier application number: M012 Allergy Relief 4 Hour CHLORPHENIRAMINE MALEATE Geri-Care Pharmaceutical Corp 92d90b41-0627-121e-e053-2995a90a2df1 2023-10-26 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Cherry MENTHOL Riclan S.A. 8e471265-3594-451a-8921-f0db474abe85 2023-10-26 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Eucalyptus MENTHOL Riclan S.A. 1141593a-f3ba-4adf-b332-f9fcb0b5a013 2023-10-26 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Honey Lemon MENTHOL Riclan S.A. f6271e85-9ca2-41d3-9bff-a13670ac5b80 2023-10-26 Warnings Exact identifier application number: M012 Freegells Cough Drops Menthol Strawberry MENTHOL Riclan S.A. da2bbc92-7d96-4f3e-89e2-c2a9e3e4b457 2023-10-26 Warnings Exact identifier application number: M012 DG Health Cough Drops Assorted Flavors MENTHOL Dollar General Corporation c731d255-40f2-3cb3-e053-2a95a90a8877 2023-10-26 Warnings Exact identifier application number: M012 ALKA SELTZER PLUS Cold Day and Night Effervescent ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE Sincronia Logistica, S.A. de C.V. c478df69-823a-4112-8f44-323249a9f38f 2023-10-23 Warnings Exact identifier application number: M012
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 54859-509-16 54859050916 473 mL in 1 BOTTLE (54859-509-16) 473 ml 2022-07-01 0000-00-00 No No Current