FDA.reportPublic FDA data

Tussin DM Cough and Chest

Product NDC
67091-265
11-digit product format
670910265
Labeler code
67091
Product ID
67091-265_88d5ba88-a6f2-4cc2-8623-0d0f10016d1e
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
WinCo Foods, LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-12-31
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20; 200 mg/10mL; mg/10mL
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct67091-265DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67091-26567091-265-18DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…

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 Cough and Chest
Brand name suffix
Non Drowsy
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/10mL
GUAIFENESIN200 mg/10mL

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
13eb459c-3075-4038-8062-9ee7175b2ab9Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67091-265-18Tussin DM Cough and ChestNon Drowsy1 in 1 BOXLIQUID16
67091-265-18Tussin DM Cough and ChestNon Drowsy118 mL in 1 BOTTLE, PLASTICLIQUID1186

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHTUSSIN DM COUGH AND CHEST NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [WINCO FOODS, LLC]2
GUAIFENESINACTIVE INGREDIENT495W7451VQTUSSIN DM COUGH AND CHEST NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [WINCO FOODS, LLC]2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSTUSSIN DM COUGH AND CHEST NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [WINCO FOODS, LLC]2
GUAIFENESINACTIVE MOIETY495W7451VQTUSSIN DM COUGH AND CHEST NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [WINCO FOODS, LLC]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLTUSSIN DM COUGH AND CHEST NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [WINCO FOODS, LLC]2
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2TUSSIN DM COUGH AND CHEST NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [WINCO FOODS, LLC]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATUSSIN DM COUGH AND CHEST NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [WINCO FOODS, LLC]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTUSSIN DM COUGH AND CHEST NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [WINCO FOODS, LLC]2
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6STUSSIN DM COUGH AND CHEST NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [WINCO FOODS, LLC]2
MENTHOL, UNSPECIFIED FORMINACTIVE INGREDIENTL7T10EIP3ATUSSIN DM COUGH AND CHEST NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [WINCO FOODS, LLC]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYTUSSIN DM COUGH AND CHEST NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [WINCO FOODS, LLC]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUTUSSIN DM COUGH AND CHEST NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [WINCO FOODS, LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RTUSSIN DM COUGH AND CHEST NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [WINCO FOODS, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67091-265TUSSIN DM COUGH AND CHEST NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [WINCO FOODS, LLC]6Current NDC, Legacy NDC, 2 package rows20240926_13eb459c-3075-4038-8062-9ee7175b2ab9.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 173 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Phenylephrine HCl Maximum StrengthPHENYLEPHRINE HCLA-S Medication Solutionsfcb769d0-aa45-48eb-acd0-2247b392f9fe2023-12-09WarningsExact identifier
application number: M012
Daytime and Nighttime Severe Honey Cold and FluDAYTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN AND NIGHTTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATETARGET CORPORATION0bf915af-a016-0a46-e063-6394a90aacf52023-12-08WarningsExact identifier
application number: M012
Maximum Strength Daytime Severe and Nighttime Cold and FluDAYTIME- ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, NIGHTTIME - ACETAMINOPHEN, DIPHENHYDRAMINE HCITARGET Corporation0bf9c0df-7676-3060-e063-6394a90a16c72023-12-08WarningsExact identifier
application number: M012
NazalNAPHAZOLINE HYDROCHLORIDESato Pharmaceutical Co., Ltd.4d4043f8-5ed3-4027-beb6-687db13082022023-12-06WarningsExact identifier
application number: M012
Family Wellness OxymetazolineOXYMETAZOLINEFAMILY DOLLAR (Family Wellness)8b4557d4-74a0-400f-ad7a-6d31473b3c672023-12-06WarningsExact identifier
application number: M012
Childrens Plus FluACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCIDolgencorp, Inc. (DOLLAR GENERAL & REXALL)1598e6f8-08ee-4216-a5ab-76cad37b09a72023-12-06WarningsExact identifier
application number: M012
Welmedix HomeCare PRO Fragile Skin ProtectantPETROLATUMWelmedix LLC6e8d7151-c7fc-4b8f-9343-4a9f0f4e37cf2023-12-05WarningsExact identifier
application number: M012
Welmedix HomeCare PRO Extra Strength Rapid Rash ReliefPETROLATUM, ZINC OXIDEWelmedix LLC551e6cce-7adc-4e98-baff-2703b83d75262023-12-05WarningsExact identifier
application number: M012
Stona-SACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDESato Pharmaceutical Co., Ltd.2f4c2791-76ec-4f95-a50b-a1eb8dbc9bc12023-12-04WarningsExact identifier
application number: M012
Stona CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDESato Pharmaceutical Co., Ltd.afc95c82-18da-487b-b4bb-51e0be0378da2023-12-04WarningsExact identifier
application number: M012
No Drip Nasal MistOXYMETAZOLINE SPRAYWalgreens Companya14643a1-3d91-491a-88d6-22dccde979382023-12-04WarningsExact identifier
application number: M012
TopCare Day Time SEVERE Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLC14d53907-a4a2-4a0f-b2d6-33474945f9e12023-12-04WarningsExact identifier
application number: M012
BanophenDIPHENHYDRAMINE HCLProficient Rx LP62934d0f-b23d-4c03-9d60-a7bad41f9b422023-12-01WarningsExact identifier
application number: M012
BenadrylDIPHENHYDRAMINE HYDROCHLORIDEProficient Rx LPb1c849e5-8003-4fd3-811d-6a927523e3532023-12-01WarningsExact identifier
application number: M012
Akin Expectorant Formula Strawberry BananaGUAIFENESINSouthern Sales & Service, Inc.b63b0133-d2da-432b-a154-9e77535bbef92023-11-29WarningsExact identifier
application number: M012
Akin Cough Formula DM Strawberry BananaDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINSouthern Sales & Service, Inc.7a81efd8-775d-455e-860f-f3e3b369a0a72023-11-29WarningsExact identifier
application number: M012
AkinGUAIFENESINSouthern Sales & Service, Inc.bb2c9f21-6765-4286-bd71-de01cdf4c4e92023-11-29WarningsExact identifier
application number: M012
Akin Cough Formula DMDEXTROMETHORPHAN, GUAIFENESINSouthern Sales & Service, Inc.1f2f9b4c-ecf0-4ff6-861a-063f8a9ef74a2023-11-29WarningsExact identifier
application number: M012
diphenhydramine hydrochlorideDIPHENHYDRAMINE HYDROCHLORIDESimpex Pharma Pvt. Ltd82771f6a-8b3d-4ffa-8b35-09c2faf3582c2023-11-29WarningsExact identifier
application number: M012
SIMPEX GuaifenesinGUAIFENESINSimpex Pharma Pvt. Ltd1594f9d6-0c48-42bf-b76b-d621f215179a2023-11-29WarningsExact 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 SolutionPSN13eb459c-3075-4038-8062-9ee7175b2ab96
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD13eb459c-3075-4038-8062-9ee7175b2ab96
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY13eb459c-3075-4038-8062-9ee7175b2ab96
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSY13eb459c-3075-4038-8062-9ee7175b2ab96
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSY13eb459c-3075-4038-8062-9ee7175b2ab96

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67091-265-18670910265181 BOTTLE, PLASTIC in 1 BOX (67091-265-18) / 118 mL in 1 BOTTLE, PLASTIC2014-12-310000-00-00NoNoCurrent