FDA.reportPublic FDA data

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

Additional Listing Data#

Finished product
Yes
Brand name base
Tusnel Cough Suppressant Expectorant
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE10 mg/5mL
GUAIFENESIN100 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9D2RTI9KYH, 495W7451VQ
Rxcui996520

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
54859-509-16Tusnel Cough Suppressant Expectorant473 mL in 1 BOTTLELIQUID4733

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54859-509-16ML - Milliliter54859-509c710a6f2-4893-4233-9200-88fd2ec455f012025-12-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54859-509TUSNEL COUGH SUPPRESSANT EXPECTORANT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION, INC.]2Current NDC, Legacy NDC, 1 package rows20241222_af71cdbc-33d6-4303-b494-d7321721d3be.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSNaf71cdbc-33d6-4303-b494-d7321721d3be3
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCDaf71cdbc-33d6-4303-b494-d7321721d3be3
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSYaf71cdbc-33d6-4303-b494-d7321721d3be3
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSYaf71cdbc-33d6-4303-b494-d7321721d3be3
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSYaf71cdbc-33d6-4303-b494-d7321721d3be3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54859-509-1654859050916473 mL in 1 BOTTLE (54859-509-16) 473 ml2022-07-010000-00-00NoNoCurrent