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 90 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
G-Supress DXDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEKRAMER NOVIS5dd44337-f3aa-4e73-a206-4a29850a2f7c2025-11-12WarningsExact identifier
application number: M012
Allergy Relief CompleteDIPHENHYDRAMINE HCLWinCo Foods, LLC15b3de6c-7ccc-408b-8789-d0e2f21a88352025-11-12WarningsExact identifier
application number: M012
PRESGEN PEDIATRICGUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDEKRAMER NOVIS12fb91e5-6059-4b3a-a2de-762aa51a25b72025-11-12WarningsExact identifier
application number: M012
SorbugenDEXTROMETHORPHAN HYDROBROMIDE, GLYCEROL GUAIACOLATEKramer Novisa8f2a2d7-0360-45a8-9635-c852f4a7d7ba2025-11-12WarningsExact identifier
application number: M012
DESGEN DMDEXTROMETHORPHAN HBR ,GUAIFENESIN ,PHENYLEPHRINE HCLKramer Novis6ab47174-e1fd-47ce-8788-06b7cdad52182025-11-12WarningsExact identifier
application number: M012
PresgenGUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDEKramer Novisedad7a86-0d27-4a98-85b2-4b6725904f282025-11-12WarningsExact identifier
application number: M012
TUSSI PRES PEDIATRICGUAIFENESIN, PHENYLEPHRINE HCL,DEXTROMETHORPHAN HYDROBROMIDEKRAMER NOVISb01a45df-3cea-4729-80c1-7f35b7f707f02025-11-12WarningsExact identifier
application number: M012
TUSICOFDEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINEKramer Novise966b75c-4bb4-4216-8247-baada8f5d7592025-11-12WarningsExact identifier
application number: M012
Fast Acting Mucus Relief Maximum Strength Severe Cough and CongestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)52327ed0-ea49-4d1c-b928-20ab381be9f22025-11-11WarningsExact identifier
application number: M012
TOPCO Childrens Cough ReliefDEXTROMETHORPHAN HBR AND GUAIFENESINTopco Associates, LLCee0f5627-5104-4990-88ee-2fb46965bc1e2025-11-11WarningsExact identifier
application number: M012
TOPCARE Childrens Cold and Cough and Runny NoseACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDETopco Associates, LLC8931d4ca-c599-49be-87e1-8c0598f38b772025-11-11WarningsExact identifier
application number: M012
TOPCARE Multi Symptom Flu Relief Combo PackACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRTopco Associates, LLC01c517e5-d693-4926-9eb5-4b894a2f69172025-11-11WarningsExact identifier
application number: M012
Tylenol Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDENavajo Manufacturing Company Inc.435b4a2a-d6bf-ec25-e063-6294a90a3f062025-11-11WarningsExact identifier
application number: M012
TYLENOL Cold Plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDENavajo Manufacturing Company Inc.435e6387-1ee0-c20f-e063-6294a90adac52025-11-11WarningsExact identifier
application number: M012
BuscapinaACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEOPMX LLC10b09674-d6bd-41cd-b92c-b5b6a0fd2f5b2025-11-10WarningsExact identifier
application number: M012
TOPCARE Childrens Allergy ChewsDIPHENHYDRAMINE HCLTopco Associates, LLCb5e15dd1-6e99-411c-9183-8a4265eae4042025-11-08WarningsExact identifier
application number: M012
Severe Sinus Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINEShield Pharmaceuticals Corp103de130-ef12-4c58-bbcf-234b3f3b2cbf2025-11-08WarningsExact identifier
application number: M012
Cough Drops Dollar General Strawberry 30ctMENTHOLDollar General Corporation2b3fbab9-92b5-42a7-b27b-ff46350ce0552025-11-07WarningsExact identifier
application number: M012
Robitussin Day and Night Maximum Strength Cough DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATEHaleon US Holdings LLCb43d8fbd-1977-4465-aa64-79e7b7f54e092025-11-07WarningsExact identifier
application number: M012
Allergy plus Sinus HeadacheACETAMINOPHEN 325 MG, DIPHENHYDRAMINE HCL 12.5 MG, PHENYLEPHRINE HCL 5 MGShield Pharmaceuticals Corp093649a4-f968-49bd-83af-bb7e0f448ecf2025-11-07WarningsExact 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