FDA.reportPublic FDA data

Tusnel

Product NDC
54859-517
11-digit product format
548590517
Labeler code
54859
Product ID
54859-517_471f0d89-3e47-8d6d-e063-6294a90a508d
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
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; PHENYLEPHRINE HYDROCHLORIDE
Active strength
20; 400; 10 mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes
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]
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
Brand name suffix
DM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/5mL
GUAIFENESIN400 mg/5mL
PHENYLEPHRINE HYDROCHLORIDE10 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9D2RTI9KYHInternal UNII lookup
495W7451VQInternal UNII lookup
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1091331Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
fe457e6d-422d-496c-bcb9-33594f3c42ffAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54859-517-16TusnelDM473 mL in 1 BOTTLELIQUID4736

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54859-517-16ML - Milliliter54859-5176c7139a8-1d08-41b1-8963-70ced28665cd12019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54859-517TUSNEL DM (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION, INC.]5Current NDC, Legacy NDC, 1 package rows20241225_fe457e6d-422d-496c-bcb9-33594f3c42ff.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 97 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rompe Pecho DMDEXTROMETHORPHAN HBR, GUAIFENESINEfficient Laboratories Incd108c712-bc36-41d7-9ccd-720496b5599e2025-10-14WarningsExact identifier
application number: M012
Rompe Pechito DM for KidsDEXTROMETHORPHAN HBR, GUAIFENESINEfficient Laboratories Inc004d12e1-6e3d-84c8-e063-6394a90aa6532025-10-14WarningsExact identifier
application number: M012
VANACOF CP Allergy / CoughCHLOPHEDIANOL HCL, PYRILAMINE MALEATEGM Pharmaceuticals, INC0bdea30a-39da-6611-e063-6394a90aa4cf2025-10-14WarningsExact identifier
application number: M012
VANACOFCHLOPHEDIANOL HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE, AND PSEUDOEPHEDRINE HYDROCHLORIDEGM Pharmaceuticals, INCcf3886ab-62b3-497a-a587-18cbfbaf36342025-10-14WarningsExact identifier
application number: M012
Sugar Free Cherry Fishermans Friend Menthol Cough SuppressantMENTHOLLofthouse of Fleetwood, Ltd.42d4bafb-b630-487e-b63d-13ad37a594542025-10-14WarningsExact identifier
application number: M012
SUPRESS ADEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLDextrum Laboratories, Inc410c19f7-213d-cd99-e063-6294a90af5a32025-10-13WarningsExact identifier
application number: M012
TexaClear Pain and Chest Congestion ReliefCHOLINE SALICYLATE,GUAIFENESINGM Pharmaceuticals, INC672bc78a-2c71-4135-b64a-2b8c40ac688c2025-10-13WarningsExact identifier
application number: M012
Vapor StickCAMPHOR/MENTHOLRejoice International Corp.33d1fbf3-d33c-58b9-e063-6294a90ae0982025-10-13WarningsExact identifier
application number: M012
Nitetime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLMeijer Distribution Inc47f03174-6e91-4529-bbfa-ce58aa7b7d792025-10-13WarningsExact identifier
application number: M012
Nasal Decongestant Maximum StrengthPSEUDOEPHEDRINE HCLCHAIN DRUG MARKETING ASSOCIATION INCdb81e32b-0cad-400b-8479-a3b51de92b122025-10-10WarningsExact identifier
application number: M012
Giltuss Childrens Cough and ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEGil Pharmaceutical Corp852b77ae-a5ac-3ead-e053-2a91aa0a54bd2025-10-09WarningsExact identifier
application number: M012
Giltuss Cough and ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEGil Pharmaceutical Corp8503c956-42a5-7684-e053-2991aa0adb272025-10-09WarningsExact identifier
application number: M012
Giltuss HBP Cough and Chest CongestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINGil Pharmaceutical Corp852ceea2-d6a1-6de2-e053-2a91aa0ad50d2025-10-09WarningsExact identifier
application number: M012
Giltuss Childrens Cough and Chest CongestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINGil Pharmaceutical Corp852d5f01-9289-5515-e053-2a91aa0acf322025-10-09WarningsExact identifier
application number: M012
Giltuss Diabetic Cough and ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINGil Pharmaceutical Corp85183b38-ce2a-0e0e-e053-2991aa0a336f2025-10-09WarningsExact identifier
application number: M012
Giltuss MultiSymptom Cold and FluACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEGiltuss Pharmaceutical Corp8518fd91-981e-de78-e053-2a91aa0afcb22025-10-09WarningsExact identifier
application number: M012
Giltuss Childrens MultiSymptom Cold and FluACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEGiltuss Pharmaceutical Corp852c8cd6-271f-0fa8-e053-2991aa0ab1792025-10-09WarningsExact identifier
application number: M012
Giltuss Allergy Plus Cough and CongestionCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEGil Pharmaceutical Corp85065cf3-386d-22d5-e053-2a91aa0a72da2025-10-09WarningsExact identifier
application number: M012
Giltuss Honey Cough and Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINGil Pharmaceutical Corpa8b2c847-25e9-8714-e053-2995a90a73ce2025-10-09WarningsExact identifier
application number: M012
Giltuss Childrens Allergy Plus Cough and CongestionCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEGil Pharmaceutical Corp852c5a57-7ee4-3c5c-e053-2a91aa0a14332025-10-09WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1091331dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 5 mL Oral SolutionPSNfe457e6d-422d-496c-bcb9-33594f3c42ff6
1091331dextromethorphan hydrobromide 4 MG/ML / guaifenesin 80 MG/ML / phenylephrine hydrochloride 2 MG/ML Oral SolutionSCDfe457e6d-422d-496c-bcb9-33594f3c42ff6
1091331dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG per 5 ML Oral SolutionSYfe457e6d-422d-496c-bcb9-33594f3c42ff6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54859-517-1654859051716473 mL in 1 BOTTLE (54859-517-16) 473 ml2019-05-010000-00-00NoNoCurrent