FDA.reportPublic FDA data

Tusnel DM

Product NDC
54859-603
11-digit product format
548590603
Labeler code
54859
Product ID
54859-603_47463023-1b8c-729b-e063-6394a90a8dce
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan, Guiafenesin, Pseudoephedrine HCl
Dosage form
SOLUTION/ DROPS
Route
ORAL
Labeler
Llorens Pharmaceutical International Division
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1993-01-01
Substance
GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
25; 7.5; 2.5 mg/mL; mg/mL; mg/mL
Pharmacologic classes
Adrenergic alpha-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-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage54859-603-02e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage54859-603-029bebd1f3094a…5416666fcb17…

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 DM
Brand name suffix
Pediatric
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN25 mg/mL
PSEUDOEPHEDRINE HYDROCHLORIDE7.5 mg/mL
DEXTROMETHORPHAN HYDROBROMIDE2.5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
495W7451VQInternal UNII lookup
6V9V2RYJ8NInternal UNII lookup
9D2RTI9KYHInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1241674Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d915eab8-013e-4ce3-b358-0d531e5ca1baAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54859-603-022020-12-23C16284748780-19d75b9d0-98b6-f424-e053-dadaa90a57ceLlorens-Tusnel DMPedDrops 603
54859-603-022020-01-31C16284748780-19d75b9d0-98b6-f424-e053-dadaa90a57ceLlorens-Tusnel DMPedDrops 603

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54859-603-02Tusnel DMPediatric60 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS609

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54859-603-02ML - Milliliter54859-603f2d07a6c-f7f3-4c44-9465-b222a0bafdb712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHTUSNEL DM PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) SOLUTION/ DROPS [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]5
GuaifenesinACTIVE INGREDIENT495W7451VQTUSNEL DM PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) SOLUTION/ DROPS [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]5
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NTUSNEL DM PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) SOLUTION/ DROPS [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]5
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSTUSNEL DM PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) SOLUTION/ DROPS [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]5
GuaifenesinACTIVE MOIETY495W7451VQTUSNEL DM PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) SOLUTION/ DROPS [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]5
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FTUSNEL DM PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) SOLUTION/ DROPS [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]5
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPTUSNEL DM PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) SOLUTION/ DROPS [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]5
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LTUSNEL DM PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) SOLUTION/ DROPS [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTUSNEL DM PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) SOLUTION/ DROPS [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]5
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTUSNEL DM PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) SOLUTION/ DROPS [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TUSNEL DM PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) SOLUTION/ DROPS [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]5
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYTUSNEL DM PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) SOLUTION/ DROPS [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]5
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUTUSNEL DM PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) SOLUTION/ DROPS [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]5
WATERINACTIVE INGREDIENT059QF0KO0RTUSNEL DM PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) SOLUTION/ DROPS [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54859-603TUSNEL DM PEDIATRIC (DEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCL) SOLUTION/ DROPS [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]8Current NDC, Legacy NDC, 1 package rows20241222_d915eab8-013e-4ce3-b358-0d531e5ca1ba.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 152 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Menthol Cough DropsMENTHOLBoston Nutraceutical Production SL857363b6-e025-e074-e053-2a91aa0a43792024-10-07WarningsExact identifier
application number: M012
Menthol Cough DropsMENTHOLBoston Nutraceutical Production SL857365ba-895e-4a63-e053-2991aa0a8b9f2024-10-07WarningsExact identifier
application number: M012
Menthol Vapor Cough DropsMENTHOLBOSTON NUTRACEUTICAL PRODUCTION, S.La7062db1-8201-b400-e053-2a95a90a55e82024-10-07WarningsExact identifier
application number: M012
Honey Lemon Cough DropsMENTHOLBoston Nutraceutical Production SLb8f48a47-6871-f7ed-e053-2995a90a16f32024-10-07WarningsExact identifier
application number: M012
Honey Lemon Cough DropsMENTHOLBoston Nutraceutical Production SL856f0bd8-354b-a002-e053-2a91aa0a80222024-10-07WarningsExact identifier
application number: M012
Honey Lemon Cough DropsMENTHOLBoston Nutraceutical Production SL83c4928a-eea6-e176-e053-2991aa0a6bb12024-10-07WarningsExact identifier
application number: M012
Natural Herbal Cough DropsMENTHOLBOSTON NUTRACEUTICAL PRODUCTION, S.Lc2340f56-9a8e-4eea-e053-2995a90a78fc2024-10-07WarningsExact identifier
application number: M012
Natural Herbal Cough DropsMENTHOLBOSTON NUTRACEUTICAL PRODUCTION, S.La706ee9c-9ed0-d3f1-e053-2a95a90a26d62024-10-07WarningsExact identifier
application number: M012
Cough DropsMENTHOLTopco Associates LLCeff0b37b-6c08-b687-e053-2a95a90a11a92024-10-07WarningsExact identifier
application number: M012
Sugar Free Cough DropsMENTHOLTopco Associates LLCefcf2edd-21a3-45f9-e053-2995a90a38652024-10-07WarningsExact identifier
application number: M012
Cough DropsMENTHOLTopco Associates LLCeff65505-8846-35c2-e053-2a95a90a6b792024-10-07WarningsExact identifier
application number: M012
Sugar Free Cough DropsMENTHOLTopco Associates LLCeff0fdfe-695a-4e62-e053-2a95a90ab50f2024-10-07WarningsExact identifier
application number: M012
Cough DropsMENTHOLTopco Associates LLCeff1a70f-fa71-52b2-e053-2995a90a038c2024-10-07WarningsExact identifier
application number: M012
Honey Lemon Menthol Cough DropsHONEY LEMON MENTHOLTopco Associates LLCf5be283b-524d-26af-e053-2995a90a39722024-10-07WarningsExact identifier
application number: M012
Cough DropsMENTHOLTopco Associates LLCeff16ba3-7e30-aa93-e053-2995a90a64cb2024-10-07WarningsExact identifier
application number: M012
Menthol Cough DropsMENTHOLTarget Corporation Inc.ebf6bcf5-9384-052a-e053-2a95a90a30a52024-10-07WarningsExact identifier
application number: M012
Rompe Pecho SF Flu SF FluBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBREfficient Laboratories Inc06eac696-e8f6-ac50-e063-6394a90a2ed62024-10-07WarningsExact identifier
application number: M012
dg health nasal fourPHENYLEPHRINE HYDROCHLORIDEDolgencorp, LLCceeeb016-8e46-40b8-9923-8a4270475f452024-10-04WarningsExact identifier
application number: M012
Topcare Nasal FourPHENYLEPHRINE HYDROCHLORIDETopco Associates LLC99bc8829-167b-4cf8-8421-57da369f24cd2024-10-04WarningsExact identifier
application number: M012
basic care nasalPHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC858648f6-f454-4008-9ea8-ad060c2178332024-10-04WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1241674dextromethorphan HBr 2.5 MG / guaiFENesin 25 MG / pseudoephedrine HCl 7.5 MG in 1 mL Oral SolutionPSNd915eab8-013e-4ce3-b358-0d531e5ca1ba9
1241674dextromethorphan hydrobromide 2.5 MG/ML / guaifenesin 25 MG/ML / pseudoephedrine hydrochloride 7.5 MG/ML Oral SolutionSCDd915eab8-013e-4ce3-b358-0d531e5ca1ba9
1241674dextromethorphan hydrobromide 2.5 MG / guaifenesin 25 MG / pseudoephedrine hydrochloride 7.5 MG per 1 ML Oral SolutionSYd915eab8-013e-4ce3-b358-0d531e5ca1ba9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54859-603-025485906030260 mL in 1 BOTTLE, DROPPER (54859-603-02) 60 ml1993-01-010000-00-00NoNoCurrent