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 107 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DISCOUNT DRUG MARTCOUGH DROPS VITAMIN C SUGAR-FREEDISCOUNT DRUG MART06673358-1afc-4d75-e063-6394a90a6ab12025-09-03WarningsExact identifier
application number: M012
ValuMeds Cough Relief, Dextromethorphan HbrDEXTROMETHORPHAN HYDROBROMIDECabinet Health P.B.C.b16a81db-d9bc-4cce-8ec2-dc189184931e2025-09-03WarningsExact identifier
application number: M012
topcare day time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLC256d96f0-67bf-42d2-85ef-f49625c5910f2025-09-02WarningsExact identifier
application number: M012
TOPCARE HONEY FLAVOR COLD AND FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLC2256623c-7642-4c39-b022-bfaecc861f1c2025-09-02WarningsExact identifier
application number: M012
topcare nite time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLCef574f18-e28d-46bb-87fd-2f3b4df6dc682025-09-02WarningsExact identifier
application number: M012
Cold Multi-SymptomACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLKroger Companyf4429475-47f9-451a-bfcc-24b5ef3339232025-09-02WarningsExact identifier
application number: M012
dg health night time cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEDolgencorp Incdc8cc7a3-60a9-42f0-babd-d3c7d0276dd12025-08-29WarningsExact identifier
application number: M012
MGC Health Cough Drops Original HerbMENTHOLMedical Group Care LLC3d70ba70-eb11-f148-e063-6294a90a4c7c2025-08-28WarningsExact identifier
application number: M012
Exchange Select Cough Drops Original HerbMENTHOLArmy & Air Force Exchange Service3d7109a5-4fe1-039b-e063-6394a90a13922025-08-28WarningsExact identifier
application number: M012
MGC Health Cough Drops Honey HerbMENTHOLMedical Group Care LLC3d710deb-e42d-13eb-e063-6394a90a56e12025-08-28WarningsExact identifier
application number: M012
Sinus Relief Pressure and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLKroger Company98de5cff-3ff5-49b0-bef9-5b9ebb86491e2025-08-27WarningsExact identifier
application number: M012
Nighttime SEVEREACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEH E B0a178114-0748-4a92-9b60-a7a0a8b722872025-08-26WarningsExact identifier
application number: M012
Adult Bisolvine AdultGUAIFENESIN, DEXTROMETHORPHANMENPER DISTRIBUTORS INC.8cde5e39-a338-45af-b847-3823627f29c52025-08-25WarningsExact identifier
application number: M012
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLStrategic Sourcing Services LLC997eb228-09cb-47ad-acbb-363b05c676352025-08-25WarningsExact identifier
application number: M012
QUALITY CHOICE Childrens Allergy Relief DYE FREEDIPHENHYDRAMINE HYDROCHLORIDEQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)644f39d8-7cd6-43dd-9265-546d01d32e8c2025-08-22WarningsExact identifier
application number: M012
SanaTos Multi SymptomACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCIPharmadel LLCdf260190-89e7-b338-e053-2995a90a32cb2025-08-22WarningsExact identifier
application number: M012
Geri-Dryl allergy reliefDIPHENHYDRAMINE HCLVerityRx9ca6c0f8-71d1-4953-8e98-3311c46640112025-08-22WarningsExact identifier
application number: M012
SU PHEDRINE PE Non-Drowsy, Maximum StrengthPHENYLEPHRINE HCLSalado Sales, Inc.9056fa58-d6aa-4df5-97e0-9be3f2332f862025-08-22WarningsExact identifier
application number: M012
Chest RubCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOLMY IMPORTS USA LLC3cde0c23-5c5c-9715-e063-6294a90a94622025-08-21WarningsExact identifier
application number: M012
Severe Cold DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS Pharmacy258d27a9-fea6-4076-8dfa-77c7e982d2502025-08-20WarningsExact 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