FDA.reportPublic FDA data

Tussin DM

Product NDC
70000-0670
11-digit product format
700000670
Labeler code
70000
Product ID
70000-0670_2c5ed26b-2471-4e75-8d70-e15039a22a03
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin
Dosage form
SOLUTION
Route
ORAL
Labeler
Cardinal Health 110, LLC. DBA Leader
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-24
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20; 200 mg/20mL; mg/20mL
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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/20mL
GUAIFENESIN200 mg/20mL

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
1790650Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ebfcb699-3369-4697-9841-44015b1c9808Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0670-1Tussin DM1 in 1 CARTONSOLUTION12
70000-0670-1Tussin DM118 mL in 1 BOTTLE, PLASTICSOLUTION1182

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0670-1ML - Milliliter70000-06709e7f3114-0a02-40e5-a61b-c172f3e3756b12025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0670TUSSIN DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [CARDINAL HEALTH 110, LLC. DBA LEADER]1Current NDC, 2 package rows20250227_ebfcb699-3369-4697-9841-44015b1c9808.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 84 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quality Choice Mucus ReliefGUAIFENESINChain Drug Marketing Associationf1a73da7-0dbb-49bd-857e-7dd6bc11b63c2025-12-02WarningsExact identifier
application number: M012
Cold and Flu Relief DaytimeACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCLCARDINAL HEALTH 110, LLC. DBA LEADER 70000ac74be47-30f0-418b-bd07-502feaa9723f2025-12-01WarningsExact identifier
application number: M012
Walgreens High Blood Pressure Cold and FluACETAMINOPHEN, DEXTROMETHORPHANWALGREENS CO.bc83b55e-c3d8-460f-8ef9-ff7b2e4f72722025-12-01WarningsExact identifier
application number: M012
Walgreen High Blood Pressure Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATEWALGREENS CO.f1b7b58f-bbc3-441f-926f-d66e6a9b4e3a2025-12-01WarningsExact identifier
application number: M012
Walgreens Nighttime Kids Honey Cold Cough CongestionDOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEWALGREENS COc0f317cd-723d-47f2-b600-aaeae63994822025-12-01WarningsExact identifier
application number: M012
Walgreen Maximum Strength Severe Congestion and coughDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWALGREENS CO.b4abcb6d-f3e1-4d63-98cf-ff556ec423b62025-12-01WarningsExact identifier
application number: M012
Walgreens Daytime ChildrensCOUGH AND CHEST CONGESTIONWALGREENS CO.dd99675f-3860-42ef-999c-d9a3746a38c02025-12-01WarningsExact identifier
application number: M012
Adult Cough plus Chest Congestion DM with HoneyDEXTROMETHORPHAN HBR, GUAIFENESINWALGREEN COMPANY5f5af13a-c2a3-4bbe-880e-9c57b36e92342025-12-01WarningsExact identifier
application number: M012
Walgreens Maximum Strength Severe Congestion and CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEWALGREEN COMPANYb2e08f4d-9753-4767-a8eb-3740dd1034cc2025-12-01WarningsExact identifier
application number: M012
WALGREENS Cold Cough and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEWALGREENS CO.1e903034-942e-4c6e-9f96-eb097c2665802025-12-01WarningsExact identifier
application number: M012
Walgreens DAY and NIGHT PACKDEXTROMETHORPHAN HBR, GUAIFENESIN, CHLORPHENIRAMINE MALEATEWALGREEN COcb87e57b-ff06-4973-9751-137c7021e2722025-12-01WarningsExact identifier
application number: M012
WALGREEN Multi Symptom Flu Relief Combo PackACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRWALGREENS CO.b7b1d604-921d-4ae7-93de-dcf690d421b42025-12-01WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLMeijer Distribution Inc235b2866-bbda-7148-e063-6394a90a898f2025-12-01WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLWhole Foods Market, INC.32352109-31dc-8e6f-e063-6294a90a2f922025-12-01WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLBIONPHARMA INC.323347c3-d51a-4976-e063-6294a90a952e2025-12-01WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLWALGREEN COMPANY2969ba8f-c477-222a-e063-6394a90af7032025-12-01WarningsExact identifier
application number: M012
CareAll Medicated Chest RubCAMPHOR, MENTHOL, EUCALYPTUSNew World Imports, Inc4cd2f751-e072-4f4e-b059-ed1dfcc60c6b2025-12-01WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCVS PHARMACY, INCbbb1b395-48d9-4859-ad52-6650961089d92025-12-01WarningsExact identifier
application number: M012
Severe Sinus Pain and CongestionACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDfbc541ac-9465-4296-bb1e-811b9d811f402025-11-26WarningsExact identifier
application number: M012
Daytime Severe and Nighttime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLGrocery Outlet, Inc.447951e6-459d-0a52-e063-6294a90a62262025-11-26WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1790650dextromethorphan HBr 10 MG / guaiFENesin 100 MG in 10 mL Oral SolutionPSNebfcb699-3369-4697-9841-44015b1c98082
1790650dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML Oral SolutionSCDebfcb699-3369-4697-9841-44015b1c98082
1790650dextromethorphan HBr 10 MG / guaifenesin 100 MG per 10 ML Oral SolutionSYebfcb699-3369-4697-9841-44015b1c98082
1790650dextromethorphan HBr 20 MG / guaifenesin 200 MG per 20 ML Oral SolutionSYebfcb699-3369-4697-9841-44015b1c98082
1790650dextromethorphan HBr 5 MG / guaifenesin 50 MG per 5 ML Oral SolutionSYebfcb699-3369-4697-9841-44015b1c98082

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70000-0670-1700000670011 BOTTLE, PLASTIC in 1 CARTON (70000-0670-1) / 118 mL in 1 BOTTLE, PLASTIC2025-02-24NoNoCurrent