FDA.reportPublic FDA data

TUSSIN COUGH

Product NDC
57243-503
11-digit product format
572430503
Labeler code
57243
Product ID
57243-503_0019a922-379e-42b7-9443-8e313504ce1b
Type
HUMAN OTC DRUG
Nonproprietary name
DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Dosage form
LIQUID
Route
ORAL
Labeler
Salado Sales, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-01-01
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 COUGH
Brand name suffix
EXPECTORANT COUGH SUPRESSANT DM
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
e25727d0-7dd7-4ef5-b064-7938679f075fAvailable 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
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57243-503-24TUSSIN COUGHEXPECTORANT COUGH SUPRESSANT DM118 mL in 1 BOTTLELIQUID1188

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHTUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [SALADO SALES, INC.]6
GUAIFENESINACTIVE INGREDIENT495W7451VQTUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [SALADO SALES, INC.]6
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSTUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [SALADO SALES, INC.]6
GUAIFENESINACTIVE MOIETY495W7451VQTUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [SALADO SALES, INC.]6
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLTUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [SALADO SALES, INC.]6
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2TUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [SALADO SALES, INC.]6
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [SALADO SALES, INC.]6
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [SALADO SALES, INC.]6
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6STUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [SALADO SALES, INC.]6
MENTHOLINACTIVE INGREDIENTL7T10EIP3ATUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [SALADO SALES, INC.]6
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYTUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [SALADO SALES, INC.]6
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUTUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [SALADO SALES, INC.]6
WATERINACTIVE INGREDIENT059QF0KO0RTUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [SALADO SALES, INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57243-503TUSSIN COUGH EXPECTORANT COUGH SUPRESSANT DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) LIQUID [SALADO SALES, INC.]8Current NDC, Legacy NDC, 1 package rows20231230_e25727d0-7dd7-4ef5-b064-7938679f075f.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 169 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Severe Sinus Relief MistOXYMETAZOLINE SPRAYWalgreens Company847f47d9-62b1-49a3-8bb3-9bf275685bd22024-02-14WarningsExact identifier
application number: M012
Allergy Sinus, Lil Drug StoreACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, CHLORPHENIRAMINE MALEATELil' Drug Store Products, Inc.1145440e-b37a-6e5e-e063-6294a90ab4a02024-02-13WarningsExact identifier
application number: M012
Guaifenesin and Codeine PhosphateGUAIFENESIN AND CODEINE PHOSPHATEA-S Medication Solutions36140639-e7a8-43bc-83e2-469430af9d1a2024-02-13WarningsExact identifier
application number: M012
Theraflu ExpressMax Daytime Severe Cold and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLHaleon US Holdings LLCff48b55a-0d32-47d6-941d-d99c7cf52f942024-02-12WarningsExact identifier
application number: M012
Childrens Robitussin Cough and Chest Congestion DMDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINHaleon US Holdings LLC15950273-14c9-4a0b-bbb4-683048add7222024-02-08WarningsExact identifier
application number: M012
THERAFLU Severe Cold Relief DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLHaleon US Holdings LLC7d902237-a990-4c5e-875b-291e124e143b2024-02-03WarningsExact identifier
application number: M012
Tussin Cough and Chest Congestion DMDEXTROMETHORPHAN HBR, GUAIFENESINBest Choice (Valu Merchandisers Company)0f2d371d-f890-41e5-ac11-db5559d324662024-02-02WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief NighttimeACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLHaleon US Holdings LLC4daca846-8511-4303-9e6c-9469f7f260ba2024-02-02WarningsExact identifier
application number: M012
CVS Health COUGH SUPPRESSANT SOFTGELDEXTROMETHORPHAN HYDROBROMIDECVS Pharmacy, Inc.f676dfeb-fba8-419d-8a47-c3880e4100cc2024-02-02WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReadyInCaseACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEP & L Development, LLC155a7168-b568-41f4-b8a2-214889b4eccf2024-02-02WarningsExact identifier
application number: M012
Vaporizing Chest Rub Lavender 4ozCAMPHOR/MENTHOLRejoice International Corp.104e1a38-3472-b9e2-e063-6294a90a38cf2024-02-01WarningsExact identifier
application number: M012
Vaporizing Chest Rub Lavender 4ozCAMPHOR/MENTHOLChina Ningbo Shangge Cosmetics Technology Corp.104f5b07-eed2-566c-e063-6294a90a65052024-02-01WarningsExact identifier
application number: M012
CHILDRENS COLD COUGH and SORE THROAT MIXED BERRYACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLAptaPharma Inc.5962a73e-72e4-493b-94a7-43bc6cf9c82f2024-02-01WarningsExact identifier
application number: M012
good sense allergy reliefDIPHENHYDRAMINE HYDROCHLORIDEL. Perrigo Company2cfa69b4-e33f-442a-a6df-b021b041da142024-02-01WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief Daytime and Theraflu Severe Cold Relief NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCLHaleon US Holdings LLCe5ef7b85-feee-44a7-bd0e-ed91352c74342024-01-31WarningsExact identifier
application number: M012
SEVERE CONGESTION and COUGH MAXDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLAptaPharma Inc.17a07d2d-f2da-4e51-9a77-6f0c174987bb2024-01-31WarningsExact identifier
application number: M012
Maximum strength Max Cold and SinusACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLAptaPharma Inc.263dae13-5f92-4505-8bcc-e903d05b9a0c2024-01-31WarningsExact identifier
application number: M012
THERAFLU POWERPODS NIGHTTIME SEVERE COLDACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLHaleon US Holdings LLC39f9feef-4bf2-4f10-9fff-22bbb1d8a4712024-01-30WarningsExact identifier
application number: M012
Theraflu Daytime Severe Cold and CoughACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINEHaleon US Holdings LLCc0689223-5c90-4dbc-bbfa-f94e267504c32024-01-28WarningsExact identifier
application number: M012
THERAFLU MULTI-SYMPTOM SEVERE COLDACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLHaleon US Holdings LLCa4c56ca0-7785-404b-996d-137cc135f2702024-01-28WarningsExact 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 SolutionPSNe25727d0-7dd7-4ef5-b064-7938679f075f8
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCDe25727d0-7dd7-4ef5-b064-7938679f075f8
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSYe25727d0-7dd7-4ef5-b064-7938679f075f8
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSYe25727d0-7dd7-4ef5-b064-7938679f075f8
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSYe25727d0-7dd7-4ef5-b064-7938679f075f8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57243-503-2457243050324118 mL in 1 BOTTLE (57243-503-24) 118 ml2012-01-010000-00-00NoNoCurrent