FDA.reportPublic FDA data

Curewell Tussin DM

Product NDC
85111-802
11-digit product format
851110802
Labeler code
85111
Product ID
85111-802_51dbb3fc-e87e-7807-e063-6394a90af808
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan, Guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
RMT HEALTH LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-06-01
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
Curewell Tussin DM
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
4fe9ad93-cdc4-b4df-e063-6294a90a90aeAvailable 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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85111-802-16Curewell Tussin DM473 mL in 1 BOTTLELIQUID4731

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 20 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEHealth Pharma USA LLC319e84fd-4033-f5eb-e063-6394a90aa2f32026-06-27WarningsExact identifier
application number: M012
HyVee Cough Drops MentholMENTHOLHY-VEE, INC47a6f3c3-a6fa-dd61-e063-6394a90a49652026-06-26WarningsExact identifier
application number: M012
HyVee Cough Drops CherryMENTHOLHY-VEE, INC47a717e9-56b3-e771-e063-6394a90a5c172026-06-26WarningsExact identifier
application number: M012
Calmco Allergy ReliefDIPHENHYDRAMINE HCLCalmCo LLC5532fd37-cdd6-97ab-e063-6394a90a3c772026-06-26WarningsExact identifier
application number: M012
Dr Kids Allergy ReliefDIPHENHYDRAMINE HCLCalmCo LLC5533e705-b8d5-71cf-e063-6394a90a20102026-06-26WarningsExact identifier
application number: M012
Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine HydrochlorideACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDEHHH Pharmaceuticals265f1ce7-160c-4dda-b2e0-b78d68f962bd2026-06-26WarningsExact identifier
application number: M012
Allergy ReliefCHLORPHENIRAMINE MALEATEBryant Ranch Prepackee052b39-1658-4071-b081-5433c87b5e4a2026-06-25WarningsExact identifier
application number: M012
Allergy Multi-SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCLDOLGENCORP, LLCfae1499a-7029-4208-8436-4d330347b9152026-06-25WarningsExact identifier
application number: M012
Sinus Pressure and Pain Maximum StrengthACETAMINOPHEN, PHENYLEPHRINE HCLDOLGENCORP, LLC4fe8f124-ac80-40b4-8e1d-96709c459a4f2026-06-25WarningsExact identifier
application number: M012
Allergy and Sinus HeadacheACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICE91268cd0-c151-4744-a715-a57af3f3a3142026-06-25WarningsExact identifier
application number: M012
Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.a3c4b9c3-bdb1-4f79-bee6-1bb6bec215ea2026-06-24WarningsExact identifier
application number: M012
Cold and Flu DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICEcb475e7f-aec1-415d-9770-07cce4e02c072026-06-24WarningsExact identifier
application number: M012
Broncolito ChildrenDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEPharmadel LLC509f5b72-9894-ef44-e063-6394a90a6d072026-06-23WarningsExact identifier
application number: M012
Neo-Synephrine SeverePHENYLEPHRINE HYDROCHLORIDEBF ASCHER AND CO INC54edaff7-d241-dc90-e063-6294a90ac64d2026-06-23WarningsExact identifier
application number: M012
AXIV Sinus Severe Ultra Fine MistOXYMETAZOLINE HYDROCHLORIDE.VIVUNT PHARMA LLC4b81abf9-3ea7-e996-e063-6394a90a71e82026-06-23WarningsExact identifier
application number: M012
AXIV Sinus OVERNIGHTOXYMETAZOLINE HYDROCHLORIDE.VIVUNT PHARMA LLC54e03a63-f978-33d4-e063-6394a90a30f22026-06-23WarningsExact identifier
application number: M012
equaline daytime cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFI9a199782-5d7e-449b-a86c-969746f0e96f2026-06-23WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRWalgreen Company542b9861-8055-45f6-8cbf-9fe5cde1c4d92026-06-23WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLBIONPHARMA INC.3c1953a1-32e9-6c81-e063-6294a90a9fa22026-06-22WarningsExact identifier
application number: M012
DAYTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED59db2573-7ebb-4cf9-bfe3-428929bb4eeb2026-06-22WarningsExact 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 SolutionPSN4fe9ad93-cdc4-b4df-e063-6294a90a90ae2
996520dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD4fe9ad93-cdc4-b4df-e063-6294a90a90ae2
996520dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY4fe9ad93-cdc4-b4df-e063-6294a90a90ae2
996520dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral SolutionSY4fe9ad93-cdc4-b4df-e063-6294a90a90ae2
996520dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral SolutionSY4fe9ad93-cdc4-b4df-e063-6294a90a90ae2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85111-802-1685111080216473 mL in 1 BOTTLE (85111-802-16) 473 ml2026-06-01NoNoCurrent