FDA.reportPublic FDA data

Tussin DM

Product NDC
83324-327
11-digit product format
833240327
Labeler code
83324
Product ID
83324-327_11cb4fdd-3b49-4cea-b54b-62b3c0095eb2
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin
Dosage form
SOLUTION
Route
ORAL
Labeler
Chain Drug Marketing Association, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-09-02
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

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83324-327-04Tussin DM1 in 1 CARTONSOLUTION12
83324-327-04Tussin DM118 mL in 1 BOTTLE, PLASTICSOLUTION1182

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 163 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Night Time Cold and Flu Relief Multi SymptomACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEQUALITY CHOICE (Chain Drug Marketing Association)07c7c0d9-f063-4efc-8a08-2a1bfa9ca84a2024-05-01WarningsExact identifier
application number: M012
Night Time Cold and Flu Multi SymptomACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEQUALITY CHOICE (Chain Drug Marketing Association)dbfb8971-a122-4a97-a665-e3f0d494876e2024-05-01WarningsExact identifier
application number: M012
Daytime Cold and Flu Non DrowsyACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLP & L Development, LLCc08b150c-d821-466c-8521-f77535d6af1e2024-04-30WarningsExact identifier
application number: M012
childrens allergy reliefDIPHENHYDRAMINE HYDROCHLORIDEWalgreen Company7848bb09-2af8-47f6-b32d-96635a750a552024-04-29WarningsExact identifier
application number: M012
NASAL and SINUS DECONGESTANTPHENYLEPHRINE HYDROCHLORIDEJHK Inc dba American Safety & First Aid63e51305-2575-49c4-9fda-7b3e1b4b6ede2024-04-26WarningsExact identifier
application number: M012
Robitussin Honey Severe Cough, Flu Plus Sore Throat NighttimeACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEHaleon US Holdings LLC7decc168-e847-4bbe-910b-26081469406f2024-04-26WarningsExact identifier
application number: M012
Severe cold and flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCIP & L Development, LLC7c92bdcf-db1f-4299-982f-6a3da9cba6e62024-04-25WarningsExact identifier
application number: M012
Severe cold and flu NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCIP & L Development, LLC15727e06-7bfc-424e-9e68-cc9cd5695bfd2024-04-25WarningsExact identifier
application number: M012
Severe Cold and Flu Relief DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEP & L Development, LLC5872fed8-862b-44a2-a06e-51ebf86182712024-04-25WarningsExact identifier
application number: M012
CHERRY COUGH DROPS 50CTMENTHOL, UNSPECIFIED FORMJHK Inc dba American Safety & First Aid2f54b9c1-3a37-48fd-b964-6aa2631b8e622024-04-24WarningsExact identifier
application number: M012
Dye Free Allergy childrensDIPHENHYDRAMINE HYDROCHLORIDEQUALITY CHOICE (Chain Drug Marketing Association)f1a33c2f-2330-43f3-8026-de21808aec662024-04-22WarningsExact identifier
application number: M012
Cold and Flu DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLQUALITY CHOICE (Chain Drug Marketing Association)fc7954a6-d061-4160-b1d1-a19eb9eabff42024-04-22WarningsExact identifier
application number: M012
Dibromm Cold and Allergy ChildrensBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCLQUALITY CHOICE (Chain Drug Marketing Association)ea285d5a-9eb4-4f71-bb1b-4e24a89728192024-04-22WarningsExact identifier
application number: M012
Childrens AllergyDIPHENHYDRAMINE HCLQUALITY CHOICE (Chain Drug Marketing Association)c573da1e-c7ca-46e6-ad42-4ded2547afc32024-04-22WarningsExact identifier
application number: M012
Cough Relief Cough SuppressantDEXTROMETHORPHAN HBRQUALITY CHOICE (Chain Drug Marketing Association)13ae4c67-a3fe-440c-91b8-c9412626c3cd2024-04-22WarningsExact identifier
application number: M012
Pain Relief PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLQUALITY CHOICE (Chain Drug Marketing Association)47660794-22cc-4863-a183-e694d27e35432024-04-19WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReliefACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATEQUALITY CHOICE (Chain Drug Marketing Association)f9c08b18-a119-406b-bd96-73572b4445e22024-04-18WarningsExact identifier
application number: M012
Nighttime Cough ReliefDEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATEQUALITY CHOICE (Chain Drug Marketing Association)e1fa0f51-6a68-4f6f-8988-0949d1942c2f2024-04-18WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReliefACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATEQUALITY CHOICE (Chain Drug Marketing Association)025f6622-a6db-4a5c-aebd-5d54172fa4a12024-04-18WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReliefACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATEQUALITY CHOICE (Chain Drug Marketing Association)f9530d55-8226-4659-84f0-2c0b411572be2024-04-17WarningsExact 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 SolutionPSN9c9403b9-67cd-4072-a165-a67b568786be2
1790650dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML Oral SolutionSCD9c9403b9-67cd-4072-a165-a67b568786be2
1790650dextromethorphan HBr 10 MG / guaifenesin 100 MG per 10 ML Oral SolutionSY9c9403b9-67cd-4072-a165-a67b568786be2
1790650dextromethorphan HBr 20 MG / guaifenesin 200 MG per 20 ML Oral SolutionSY9c9403b9-67cd-4072-a165-a67b568786be2
1790650dextromethorphan HBr 5 MG / guaifenesin 50 MG per 5 ML Oral SolutionSY9c9403b9-67cd-4072-a165-a67b568786be2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
83324-327-04833240327041 BOTTLE, PLASTIC in 1 CARTON (83324-327-04) / 118 mL in 1 BOTTLE, PLASTIC2025-09-02NoNoCurrent