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 29 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AntihistamineDIPHENHYDRAMINE HCLGendose Pharmaceuticals, LLC847cdee8-410f-4ff3-9245-976ed6f4c7762026-05-15WarningsExact identifier
application number: M012
AntihistamineDIPHENHYDRAMINE HCLGendose Pharmaceuticals, LLCd3b2f300-d919-44cd-ab71-b74b5bdfd9772026-05-15WarningsExact identifier
application number: M012
ONESSIP DAY TIME KIDS COLD AND COUGH PLUS FEVERACETAMINOPHEN 325 MG AND DEXTROMETHORPHAN HBR 10 MG ORAL LIQUID DAY TIME KIDSMEDWISE LIFESCIENCES INC.51d52ce4-98c4-2b9b-e063-6294a90ade442026-05-15WarningsExact identifier
application number: M012
Curewell Tussin DMDEXTROMETHORPHAN, GUAIFENESINRMT HEALTH LLC4fe9ad93-cdc4-b4df-e063-6294a90a90ae2026-05-15WarningsExact identifier
application number: M012
CounterAct Cough Drops Orchard CherryMENTHOLMelaleuca, Inc.6049842c-d763-4a91-a225-976ed74e16932026-05-15WarningsExact identifier
application number: M012
CounterAct Cough Drops Honey LemonMENTHOLMelaleuca, Inc.84ac3489-9d64-401f-ab78-715af4de54402026-05-15WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold Flu and Congestion Maximum Strength Day Night Fast GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATEBayer HealthCare LLC.51e03b5b-b05a-07c1-e063-6394a90ab2012026-05-15WarningsExact identifier
application number: M012
Sinus Congestion and Pain Relief Non-Drowsy/DaytimeACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCLRite Aid Corporation38d73a1e-ac78-4f67-9291-bb48ab80306e2026-05-15WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBRWALMART INC.071615ba-f50a-4d2a-a358-43140bccce722026-05-14WarningsExact identifier
application number: M012
Severe Cold and Flu Nighttime DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLHyVee Incd4bcfabb-a054-4f53-8dc9-d361a03558b82026-05-14WarningsExact identifier
application number: M012
Cough and Chest Congestion DM AdultDEXTROMETHORPHAN HBR, GUAIFENESINCVS Pharmacy4444c05a-eba6-4633-b86f-34f455699fa92026-05-14WarningsExact identifier
application number: M012
Topcare Day Time Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTopco Associates LLCa88e5b8e-e6dd-4a1c-9628-5861d3205bdb2026-05-14WarningsExact identifier
application number: M012
equate daytime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores Inc69b24c67-cf4b-46d7-a44b-d1917cc876b12026-05-14WarningsExact identifier
application number: M012
GILTUSS DIABETIC EXGILTUSS DIABETIC EXGil Pharmaceutical Corpab7915e7-323a-4fe1-887a-a3bd3f0aac982026-05-13WarningsExact identifier
application number: M012
Giltuss EX Maximum Strength ExpectorantGILTUSS EX MAXIMUM STRENGTH EXPECTORANTGil Pharmaceutical Corp950db1ca-6936-47f8-a112-e3594d4c922c2026-05-13WarningsExact identifier
application number: M012
Giltuss EX ExpectorantGILTUSS EX EXPECTORANTGil Pharmaceutical Corp3b363fb9-c4d3-446f-927c-f705ffc715b52026-05-13WarningsExact identifier
application number: M012
Giltuss HBP EX ExpectorantGILTUSS HBP EX EXPECTORANTGil Pharmaceutical Corp31bd6356-27cf-4188-8fd5-9cd9392021ca2026-05-13WarningsExact identifier
application number: M012
Halls Honey LemonMENTHOLMondelez Global LLCaec46410-ffb1-4db4-b232-82110c562f692026-05-13WarningsExact identifier
application number: M012
Mucinex Fast-Max Chest Congestion Honey and Berry FlavorGUAIFENESINReckitt Benckiser LLC8ec74cf2-88f5-40be-87e2-b756ab8417542026-05-13WarningsExact identifier
application number: M012
Mucinex Fast-Max Cold and FluACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDEReckitt Benckiser LLCc16253d3-3824-458c-8840-e3a2fbe7682c2026-05-13WarningsExact 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