FDA.reportPublic FDA data

Tussin DM Cough and Chest Congestion

Product NDC
49580-0385
11-digit product format
495800385
Labeler code
49580
Product ID
49580-0385_8228de33-953b-42ee-9bad-286bd3665934
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
P & L Development, LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-03-31
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

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
Adult
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
1605844Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4af67ba7-8892-442c-b9fb-80aba9140e05Available 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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49580-0385-2Tussin DM Cough and Chest CongestionAdult118 mL in 1 BOTTLE, PLASTICLIQUID11814
49580-0385-4Tussin DM Cough and Chest CongestionAdult118 mL in 1 BOTTLE, PLASTICLIQUID11814
49580-0385-4Tussin DM Cough and Chest CongestionAdult1 in 1 BOXLIQUID114
49580-0385-8Tussin DM Cough and Chest CongestionAdult1 in 1 BOXLIQUID114
49580-0385-8Tussin DM Cough and Chest CongestionAdult237 mL in 1 BOTTLE, PLASTICLIQUID23714

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHTUSSIN DM COUGH AND CHEST CONGESTION ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AARON INDUSTRIES INC.]1
GUAIFENESINACTIVE INGREDIENT495W7451VQTUSSIN DM COUGH AND CHEST CONGESTION ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AARON INDUSTRIES INC.]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSTUSSIN DM COUGH AND CHEST CONGESTION ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AARON INDUSTRIES INC.]1
GUAIFENESINACTIVE MOIETY495W7451VQTUSSIN DM COUGH AND CHEST CONGESTION ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AARON INDUSTRIES INC.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLTUSSIN DM COUGH AND CHEST CONGESTION ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AARON INDUSTRIES INC.]1
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2TUSSIN DM COUGH AND CHEST CONGESTION ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AARON INDUSTRIES INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATUSSIN DM COUGH AND CHEST CONGESTION ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AARON INDUSTRIES INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTUSSIN DM COUGH AND CHEST CONGESTION ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AARON INDUSTRIES INC.]1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6STUSSIN DM COUGH AND CHEST CONGESTION ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AARON INDUSTRIES INC.]1
MENTHOL, UNSPECIFIED FORMINACTIVE INGREDIENTL7T10EIP3ATUSSIN DM COUGH AND CHEST CONGESTION ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AARON INDUSTRIES INC.]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYTUSSIN DM COUGH AND CHEST CONGESTION ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AARON INDUSTRIES INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUTUSSIN DM COUGH AND CHEST CONGESTION ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AARON INDUSTRIES INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RTUSSIN DM COUGH AND CHEST CONGESTION ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [AARON INDUSTRIES INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49580-0385TUSSIN DM COUGH AND CHEST CONGESTION ADULT (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [P & L DEVELOPMENT, LLC]11Current NDC, Legacy NDC, 5 package rows20240127_4af67ba7-8892-442c-b9fb-80aba9140e05.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 65 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy Relief Dye FreeDIPHENHYDRAMINE HYDROCHLORIDE 25MGWalgreens36ba3ff2-1965-aa56-e063-6294a90afe172025-12-31WarningsExact identifier
application number: M012
Sinus Congestion and Pain SevereACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCLWal-Mart Stores Incf51d1d52-39c2-4259-8b30-f9ac21edb2652025-12-31WarningsExact identifier
application number: M012
DurahistDEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCLPoly Pharmaceuticals, Inc.33d71863-5cac-669f-e063-6394a90a6f212025-12-30WarningsExact identifier
application number: M012
Chest Congestion ReliefGUAIFENESINRUGBY LABORATORIES51b088bc-b44f-44b9-a08e-133509a35a2c2025-12-30WarningsExact identifier
application number: M012
Chest Congestion Relief DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINRUGBY LABORATORIES60c9e493-f58c-45d6-bade-c952975124032025-12-30WarningsExact identifier
application number: M012
BIO-RYTUSSCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEAdvanced Generic Corporatione48e46e3-d3fa-4b25-8b07-bbecc4f0b64b2025-12-30WarningsExact identifier
application number: M012
AltitussDEXTROMETHORPHAN HBR, GUAIFENESINAlternative Pharmacal Corporatione4ac96f5-2a3a-42a8-8db5-80de4dcdbd442025-12-30WarningsExact identifier
application number: M012
BiocofDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HCLAdvanced Generic Corporation6ae6a0cb-b4fc-4e7d-aefc-6a52ca1ae3d62025-12-30WarningsExact identifier
application number: M012
Altipres PediatricDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLAdvanced Generic Corporation2a336896-a2f8-2a0c-e063-6294a90ae03a2025-12-30WarningsExact identifier
application number: M012
AltipresDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLAlternative Pharmacal Corporationc5a43107-3eb8-46bb-87bd-20deafe28c3f2025-12-30WarningsExact identifier
application number: M012
Mucus Relief DMDEXTROMETHORPHAN HBR, GUAIFENESINChain Drug Marketing Association, Inc.d02f32c1-716e-4753-abba-ff97c4dc9e222025-12-30WarningsExact identifier
application number: M012
NIGHTTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLKROGERa690f5c5-ff41-4072-e053-2995a90a8e552025-12-29WarningsExact identifier
application number: M012
NinjacofCHLOPHEDIANOL HCL AND PYRILAMINE MALEATECenturion Labs, LLCe2bca40f-9c27-ec8b-2ff0-ef9847ba20372025-12-29WarningsExact identifier
application number: M012
QUALITY CHOICECOUGH DROPS CHERRYXiamen Kang Zhongyuan Biotechnology Co., Ltd.23079194-b5e7-d5e6-e063-6394a90a4d8c2025-12-29WarningsExact identifier
application number: M012
QUALITY CHOICECOUGH DROPS HONEY LEMONXiamen Kang Zhongyuan Biotechnology Co., Ltd.2307db15-592b-138a-e063-6394a90a23a52025-12-29WarningsExact identifier
application number: M012
QUALITY CHOICE Cough Drops Vanilla HoneyCOUGH DROPS VANILLA HONEYXiamen Kang Zhongyuan Biotechnology Co., Ltd.23087ee3-26a0-e2b8-e063-6394a90abef42025-12-29WarningsExact identifier
application number: M012
QUALITY CHOICE Cough Drops Black Cherry SUGAR FREECOUGH DROPS BLACK CHERRY SUGAR FREEXiamen Kang Zhongyuan Biotechnology Co., Ltd.230883da-de48-68e9-e063-6394a90a927c2025-12-29WarningsExact identifier
application number: M012
QUALITY CHOICECOUGH DROPS VITAMIN CXiamen Kang Zhongyuan Biotechnology Co., Ltd.23086723-5718-6d02-e063-6394a90a03d22025-12-29WarningsExact identifier
application number: M012
QUALITY CHOICE Cough Drops Creamy StrawberryCOUGH DROPS CREAMY STRAWBERRYXiamen Kang Zhongyuan Biotechnology Co., Ltd.23085717-b2ee-175c-e063-6394a90a7f542025-12-29WarningsExact identifier
application number: M012
QUALITY CHOICECOUGH DROPS MENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.2307bbe9-7c8f-4eff-e063-6394a90af4c32025-12-29WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1605844dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral SuspensionPSN4af67ba7-8892-442c-b9fb-80aba9140e0514
1605844dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SuspensionSCD4af67ba7-8892-442c-b9fb-80aba9140e0514
1605844dextromethorphan HBr 20 MG / guaifenesin 200 MG per 10 ML Oral SuspensionSY4af67ba7-8892-442c-b9fb-80aba9140e0514

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49580-0385-249580038502118 mL in 1 BOTTLE, PLASTIC (49580-0385-2) 118 ml2015-03-310000-00-00NoNoCurrent
49580-0385-4495800385041 BOTTLE, PLASTIC in 1 BOX (49580-0385-4) / 118 mL in 1 BOTTLE, PLASTIC2015-03-310000-00-00NoNoCurrent
49580-0385-8495800385081 BOTTLE, PLASTIC in 1 BOX (49580-0385-8) / 237 mL in 1 BOTTLE, PLASTIC2015-03-310000-00-00NoNoCurrent