FDA.reportPublic FDA data

Tusnel

Product NDC
54859-507
11-digit product format
548590507
Labeler code
54859
Product ID
54859-507_471f0d89-3e44-8d6d-e063-6294a90a508d
Type
HUMAN OTC DRUG
Nonproprietary name
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
GUAIFENESIN
Active strength
100 mg/5mL
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
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
EX
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN100 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
495W7451VQInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310604Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
77c16288-68c4-476c-995f-86f505663270Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54859-507-04TusnelEX118 mL in 1 BOTTLELIQUID1186

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54859-507-04ML - Milliliter54859-5075c55f5ab-24dd-43cb-8a84-9705b69eb11012019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54859-507TUSNEL EX (GUAIFENESIN) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION, INC.]5Current NDC, Legacy NDC, 1 package rows20241225_77c16288-68c4-476c-995f-86f505663270.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 20 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEHealth Pharma USA LLC319e84fd-4033-f5eb-e063-6394a90aa2f32026-06-27WarningsExact identifier
application number: M012
HyVee Cough Drops MentholMENTHOLHY-VEE, INC47a6f3c3-a6fa-dd61-e063-6394a90a49652026-06-26WarningsExact identifier
application number: M012
HyVee Cough Drops CherryMENTHOLHY-VEE, INC47a717e9-56b3-e771-e063-6394a90a5c172026-06-26WarningsExact identifier
application number: M012
Calmco Allergy ReliefDIPHENHYDRAMINE HCLCalmCo LLC5532fd37-cdd6-97ab-e063-6394a90a3c772026-06-26WarningsExact identifier
application number: M012
Dr Kids Allergy ReliefDIPHENHYDRAMINE HCLCalmCo LLC5533e705-b8d5-71cf-e063-6394a90a20102026-06-26WarningsExact identifier
application number: M012
Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine HydrochlorideACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDEHHH Pharmaceuticals265f1ce7-160c-4dda-b2e0-b78d68f962bd2026-06-26WarningsExact identifier
application number: M012
Allergy ReliefCHLORPHENIRAMINE MALEATEBryant Ranch Prepackee052b39-1658-4071-b081-5433c87b5e4a2026-06-25WarningsExact identifier
application number: M012
Allergy Multi-SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCLDOLGENCORP, LLCfae1499a-7029-4208-8436-4d330347b9152026-06-25WarningsExact identifier
application number: M012
Sinus Pressure and Pain Maximum StrengthACETAMINOPHEN, PHENYLEPHRINE HCLDOLGENCORP, LLC4fe8f124-ac80-40b4-8e1d-96709c459a4f2026-06-25WarningsExact identifier
application number: M012
Allergy and Sinus HeadacheACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICE91268cd0-c151-4744-a715-a57af3f3a3142026-06-25WarningsExact identifier
application number: M012
Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.a3c4b9c3-bdb1-4f79-bee6-1bb6bec215ea2026-06-24WarningsExact identifier
application number: M012
Cold and Flu DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICEcb475e7f-aec1-415d-9770-07cce4e02c072026-06-24WarningsExact identifier
application number: M012
Broncolito ChildrenDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEPharmadel LLC509f5b72-9894-ef44-e063-6394a90a6d072026-06-23WarningsExact identifier
application number: M012
Neo-Synephrine SeverePHENYLEPHRINE HYDROCHLORIDEBF ASCHER AND CO INC54edaff7-d241-dc90-e063-6294a90ac64d2026-06-23WarningsExact identifier
application number: M012
AXIV Sinus Severe Ultra Fine MistOXYMETAZOLINE HYDROCHLORIDE.VIVUNT PHARMA LLC4b81abf9-3ea7-e996-e063-6394a90a71e82026-06-23WarningsExact identifier
application number: M012
AXIV Sinus OVERNIGHTOXYMETAZOLINE HYDROCHLORIDE.VIVUNT PHARMA LLC54e03a63-f978-33d4-e063-6394a90a30f22026-06-23WarningsExact identifier
application number: M012
equaline daytime cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFI9a199782-5d7e-449b-a86c-969746f0e96f2026-06-23WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRWalgreen Company542b9861-8055-45f6-8cbf-9fe5cde1c4d92026-06-23WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLBIONPHARMA INC.3c1953a1-32e9-6c81-e063-6294a90a9fa22026-06-22WarningsExact identifier
application number: M012
DAYTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED59db2573-7ebb-4cf9-bfe3-428929bb4eeb2026-06-22WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310604guaiFENesin 100 MG in 5 mL Oral SolutionPSN7f703c9c-2256-4524-9d31-c51919399d268
310604guaifenesin 20 MG/ML Oral SolutionSCD7f703c9c-2256-4524-9d31-c51919399d268
310604guaifenesin 100 MG per 5 ML Oral SolutionSY7f703c9c-2256-4524-9d31-c51919399d268
310604guaifenesin 100 MG per 5 ML Oral SyrupSY7f703c9c-2256-4524-9d31-c51919399d268
310604guaifenesin 200 MG per 10 ML Oral SolutionSY7f703c9c-2256-4524-9d31-c51919399d268
310604guaifenesin 300 MG per 15 ML Oral SolutionSY7f703c9c-2256-4524-9d31-c51919399d268
310604guaifenesin 400 MG per 20 ML Oral SolutionSY7f703c9c-2256-4524-9d31-c51919399d268
310604guaiFENesin 100 MG in 5 mL Oral SolutionPSN77c16288-68c4-476c-995f-86f5056632706
310604guaifenesin 20 MG/ML Oral SolutionSCD77c16288-68c4-476c-995f-86f5056632706
310604guaifenesin 100 MG per 5 ML Oral SolutionSY77c16288-68c4-476c-995f-86f5056632706
310604guaifenesin 100 MG per 5 ML Oral SyrupSY77c16288-68c4-476c-995f-86f5056632706
310604guaifenesin 200 MG per 10 ML Oral SolutionSY77c16288-68c4-476c-995f-86f5056632706
310604guaifenesin 300 MG per 15 ML Oral SolutionSY77c16288-68c4-476c-995f-86f5056632706
310604guaifenesin 400 MG per 20 ML Oral SolutionSY77c16288-68c4-476c-995f-86f5056632706

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54859-507-0454859050704118 mL in 1 BOTTLE (54859-507-04) 118 ml2019-05-010000-00-00NoNoCurrent