FDA.reportPublic FDA data

Tussin DM Cough and Chest Congestion

Product NDC
63868-868
11-digit product format
638680868
Labeler code
63868
Product ID
63868-868_84556600-bfd3-4f17-872f-4b87b0a1ff65
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
QUALITY CHOICE (Chain Drug Marketing Association)
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-09-30
Marketing end
2026-12-28
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
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 Cough and Chest Congestion
Brand name suffix
Non Drowsy

Active Ingredients#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63868-868-542023-05-11Drug Facts
63868-868-542023-05-11Drug Facts
63868-868-562023-05-11Drug Facts
63868-868-562023-05-11Drug Facts
63868-868-542023-01-30Drug Facts
63868-868-542023-01-30Drug Facts
63868-868-562023-01-30Drug Facts
63868-868-562023-01-30Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-868-54Tussin DM Cough and Chest CongestionNon Drowsy118 mL in 1 BOTTLE, PLASTICLIQUID1189
63868-868-54Tussin DM Cough and Chest CongestionNon Drowsy1 in 1 BOXLIQUID19
63868-868-56Tussin DM Cough and Chest CongestionNon Drowsy1 in 1 BOXLIQUID19
63868-868-56Tussin DM Cough and Chest CongestionNon Drowsy237 mL in 1 BOTTLE, PLASTICLIQUID2379

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-868-54ML - Milliliter63868-868c9bb4e1c-4765-49f5-aced-b5aa52b7f0d412018-03-08
63868-868-56ML - Milliliter63868-868fdf54908-cbab-4e14-a0e6-8cde43c0451912022-10-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHTUSSIN DM COUGH AND CHEST CONGESTION NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]3
GUAIFENESINACTIVE INGREDIENT495W7451VQTUSSIN DM COUGH AND CHEST CONGESTION NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]3
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSTUSSIN DM COUGH AND CHEST CONGESTION NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]3
GUAIFENESINACTIVE MOIETY495W7451VQTUSSIN DM COUGH AND CHEST CONGESTION NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLTUSSIN DM COUGH AND CHEST CONGESTION NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]3
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2TUSSIN DM COUGH AND CHEST CONGESTION NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATUSSIN DM COUGH AND CHEST CONGESTION NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTUSSIN DM COUGH AND CHEST CONGESTION NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]3
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6STUSSIN DM COUGH AND CHEST CONGESTION NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]3
MENTHOL, UNSPECIFIED FORMINACTIVE INGREDIENTL7T10EIP3ATUSSIN DM COUGH AND CHEST CONGESTION NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]3
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYTUSSIN DM COUGH AND CHEST CONGESTION NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUTUSSIN DM COUGH AND CHEST CONGESTION NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]3
WATERINACTIVE INGREDIENT059QF0KO0RTUSSIN DM COUGH AND CHEST CONGESTION NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-868TUSSIN DM COUGH AND CHEST CONGESTION NON DROWSY (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]9Current NDC, Legacy NDC, 4 package rows20240502_5da9be32-9075-4eca-bb13-ce16330e39fa.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 36 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Panadol Cold and Flu NightACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRHaleon US Holdings LLC3417993d-8e3c-23d6-e063-6394a90a7d502026-04-29WarningsExact identifier
application number: M012
Halls Sugar Free Mountain MentholMENTHOLMondelez Global LLC509f233e-ff01-8927-e063-6394a90a99292026-04-29WarningsExact identifier
application number: M012
Broncomiel AdultsDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEPharmadel LLC509c61d3-ae16-be5c-e063-6294a90a68da2026-04-29WarningsExact identifier
application number: M012
Mucus Relief DM Max Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESINTOP CARE (Topco Associates LLC)aa1eb90c-e565-455f-8978-6f2f9e00a8142026-04-29WarningsExact identifier
application number: M012
Tussin Cough and Chest Congestion DM adultDEXTROMETHORPHAN HBR, GUAIFENESINHarris Teeter, LLCe1280355-da81-489f-9bd2-ffea9a68010c2026-04-29WarningsExact identifier
application number: M012
Mucus Relief ChildrensDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTOPCO ASSOCIATES LLC7b095ec5-9951-4491-9b68-7ac0a7f100532026-04-29WarningsExact identifier
application number: M012
Mucus Relief Severe Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTOP CARE (Topco Associates LLC)98dd0ba6-0109-46b2-92df-11a0309842402026-04-28WarningsExact identifier
application number: M012
Pain, Headache and CongestionACETAMINOPHEN, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED41a77cbb-6a4d-46a4-ab27-c7affa2cc6822026-04-28WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold Flu and Congestion Severe Fast DissolveCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.dd7da15a-4e0b-405f-e053-2995a90a06d22026-04-28WarningsExact identifier
application number: M012
CAREONE CHILDRENS COLD COUGHBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDERetail Business Services, LLC382f7d51-ceb8-4bdf-9bd5-440b50c65cd32026-04-28WarningsExact identifier
application number: M012
Cold and Flu Daytime ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLL.N.K. International, Inc.1a520b4f-6a4b-4e37-94c5-9387f2e4c34a2026-04-27WarningsExact identifier
application number: M012
Childrens Multi-Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEKroger49a7cd2a-8c0e-2196-e063-6294a90a134a2026-04-27WarningsExact identifier
application number: M012
Guaifenesin,Dextromethorphan HbrGUAIFENESIN,DEXTROMETHORPHAN HBRSoftgel Healthcare Pvt Ltd3e5d978f-cc70-60a5-e063-6394a90a67d32026-04-27WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine HydrochlorideACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDESoftgel Healthcare Pvt Ltd36ced59c-12dc-441f-e063-6294a90a32392026-04-27WarningsExact identifier
application number: M012
Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mgACETAMINOPHEN, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCLSoftgel Healthcare Private Limited30ab39f3-27cc-5728-e063-6394a90a9cbe2026-04-27WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan HBr and Doxylamine SuccinateACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATESoftgel Healthcare Private Limited353f71f7-81e0-08c2-e063-6294a90acb492026-04-27WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan HBr ,GuaifenesinACETAMINOPHEN, DEXTROMETHORPHAN HBR ,GUAIFENESINSoftgel Healthcare Pvt Ltd353ef34f-760d-ae92-e063-6294a90a5b4a2026-04-27WarningsExact identifier
application number: M012
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDESOFTGEL HEALTHCARE PRIVATE LIMITED0203d919-dc1f-cca0-e063-6394a90aa1aa2026-04-27WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold Flu and Congestion Severe Fast DissolveCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.507214ad-1e06-fe21-e063-6294a90a59cd2026-04-27WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold Congestion Severe Day Night Fast DissolveASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.50738a43-7299-270c-e063-6294a90af2cc2026-04-27WarningsExact 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 SolutionPSN5da9be32-9075-4eca-bb13-ce16330e39fa9
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD5da9be32-9075-4eca-bb13-ce16330e39fa9
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY5da9be32-9075-4eca-bb13-ce16330e39fa9
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSY5da9be32-9075-4eca-bb13-ce16330e39fa9
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSY5da9be32-9075-4eca-bb13-ce16330e39fa9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63868-868-54638680868541 BOTTLE, PLASTIC in 1 BOX (63868-868-54) / 118 mL in 1 BOTTLE, PLASTIC2014-09-302026-12-28NoNoCurrent
63868-868-56638680868561 BOTTLE, PLASTIC in 1 BOX (63868-868-56) / 237 mL in 1 BOTTLE, PLASTIC2014-09-302026-12-28NoNoCurrent