FDA.reportPublic FDA data

Tussin DM

Product NDC
53942-503
11-digit product format
539420503
Labeler code
53942
Product ID
53942-503_a8caafe0-3e94-4d99-9737-48765c546c17
Type
HUMAN OTC DRUG
Nonproprietary name
DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Dosage form
LIQUID
Route
ORAL
Labeler
DeMoulas Market Basket
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-10-01
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
2027-12-31
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
Tussin DM
Brand name suffix
Cough and Chest Congestion
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
996520Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e92d2f64-9690-42d3-b787-cafade3a8999Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53942-503-26Tussin DMCough and Chest Congestion237 mL in 1 BOTTLELIQUID2378

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHTUSSIN DM COUGH AND CHEST CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DEMOULAS MARKET BASKET]6
GUAIFENESINACTIVE INGREDIENT495W7451VQTUSSIN DM COUGH AND CHEST CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DEMOULAS MARKET BASKET]6
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSTUSSIN DM COUGH AND CHEST CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DEMOULAS MARKET BASKET]6
GUAIFENESINACTIVE MOIETY495W7451VQTUSSIN DM COUGH AND CHEST CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DEMOULAS MARKET BASKET]6
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPTUSSIN DM COUGH AND CHEST CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DEMOULAS MARKET BASKET]6
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2TUSSIN DM COUGH AND CHEST CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DEMOULAS MARKET BASKET]6
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATUSSIN DM COUGH AND CHEST CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DEMOULAS MARKET BASKET]6
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTUSSIN DM COUGH AND CHEST CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DEMOULAS MARKET BASKET]6
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6STUSSIN DM COUGH AND CHEST CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DEMOULAS MARKET BASKET]6
MENTHOLINACTIVE INGREDIENTL7T10EIP3ATUSSIN DM COUGH AND CHEST CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DEMOULAS MARKET BASKET]6
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYTUSSIN DM COUGH AND CHEST CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DEMOULAS MARKET BASKET]6
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUTUSSIN DM COUGH AND CHEST CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DEMOULAS MARKET BASKET]6
WATERINACTIVE INGREDIENT059QF0KO0RTUSSIN DM COUGH AND CHEST CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DEMOULAS MARKET BASKET]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53942-503TUSSIN DM COUGH AND CHEST CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [DEMOULAS MARKET BASKET]8Current NDC, Legacy NDC, 1 package rows20231230_e92d2f64-9690-42d3-b787-cafade3a8999.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 40 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
dimaphen dmBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLPreferred Pharmaceuticals Inc.da148c1d-e394-4367-83e0-533469501b302026-04-06WarningsExact identifier
application number: M012
Cough Relief AdultDEXTROMETHORPHAN HBRTOP CARE (Topco Associates LLC)b2ebfeb3-e248-40bf-81d3-81c5fb532dbe2026-04-06WarningsExact identifier
application number: M012
Allergy Plus Sinus ReliefDIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCLRite Aid Corporation54623e2e-5f9a-426e-8f7e-ea755ff8b3f82026-04-06WarningsExact identifier
application number: M012
Cold and AllergyCHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLDOLGENCORP, LLCb55452e1-25d0-4db5-9621-83f21ec6c2982026-04-06WarningsExact identifier
application number: M012
Allergy ReliefCHLORPHENIRAMINE MALEATEStrategic Sourcing Services LLCc9fa8d93-d9d6-4206-a13d-32b9e7555e7f2026-04-02WarningsExact identifier
application number: M012
Sinus Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLKroger Company6aaed3fe-ce35-4533-aea4-80096ce8e57a2026-04-02WarningsExact identifier
application number: M012
Nasal FourPHENYLEPHRINE HYDROCHLORIDEHyVee Inc19879fc8-4962-4c6e-87ed-b874d1d564af2026-04-01WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLLidl US LLC7227b330-590b-4731-8a58-e05a0233dd8a2026-04-01WarningsExact identifier
application number: M012
SudoGestCHLORPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCLMajor Pharmaceuticals7cd8f7f3-c262-4f7c-bcaf-068be2c952f92026-04-01WarningsExact identifier
application number: M012
Sanatos Daytime ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLPharmadel LLC4c26be18-733a-e4a8-e063-6294a90a8b022026-04-01WarningsExact identifier
application number: M012
Sanatos Nighttime ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEPharmadel LLC4c26c8bf-0143-ddca-e063-6294a90a35522026-04-01WarningsExact identifier
application number: M012
Codeine-GuaifenesinCODEINE PHOSPHATE AND GUAIFENESINMethod Pharmaceuticals, LLCfe126254-6ee6-48c3-965c-96e4276a53142026-04-01WarningsExact identifier
application number: M012
Good Neighbor Pharmacy Mucus ReliefGUAIFENESINAmerisourceBergen Drug Corp200dddd9-e3ff-4cec-a164-d1c9a698f1212026-03-31WarningsExact identifier
application number: M012
Head and ColdACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLHi-Tech Nutraceuticals, LLCa39c772b-3cce-14cb-e053-2a95a90a733b2026-03-31WarningsExact identifier
application number: M012
diphenhydramine hydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst44217a8c-7656-a0f6-e063-6294a90af2ad2026-03-31WarningsExact identifier
application number: M012
Dr Kids Cough and Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINCalmCo LLC3f156679-7a91-aff1-e063-6394a90a18f62026-03-31WarningsExact identifier
application number: M012
Codeine-GuaifenesinCODEINE PHOSPHATE AND GUAIFENESINA-S Medication Solutionsc26da6e0-ab1c-46c2-acf5-0074958c03cd2026-03-31WarningsExact identifier
application number: M012
Flu HBP Maximum StrengthACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRCardinal Health 110, LLC. DBA Leaderba174fcc-da1e-420c-bf9c-179ad65c28482026-03-31WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLAmerisource Bergen8e0c6f8d-559c-45de-9362-1b713fd78a7a2026-03-30WarningsExact identifier
application number: M012
Dr. Simi Daytime Cold and FluACETAMINOPHEN 325 MG, DEXTROMETHORPHAN HBR 10 MG, PHENYLEPHRINE HCL 5 MGFarmacias De Similares TX LLC4e448fd0-cb6b-b69b-e063-6394a90afde82026-03-30WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996520dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SolutionPSNe92d2f64-9690-42d3-b787-cafade3a89998
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCDe92d2f64-9690-42d3-b787-cafade3a89998
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSYe92d2f64-9690-42d3-b787-cafade3a89998
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSYe92d2f64-9690-42d3-b787-cafade3a89998
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSYe92d2f64-9690-42d3-b787-cafade3a89998

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53942-503-2653942050326237 mL in 1 BOTTLE (53942-503-26) 237 ml2012-10-010000-00-00NoNoCurrent