FDA.reportPublic FDA data

tussin dm

Product NDC
69842-819
11-digit product format
698420819
Labeler code
69842
Product ID
69842-819_e5696529-9d70-41f8-ba5c-5b1dccae22ca
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin
Dosage form
SOLUTION
Route
ORAL
Labeler
CVS Pharmacy
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-05-04
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20; 400 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
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage69842-81969842-819-34DDiscontinued by firm2026-09-14

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69842-81969842-819-34DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69842-81969842-819-34DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

Additional Listing Data#

Finished product
Yes
Brand name base
tussin dm
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/20mL
GUAIFENESIN400 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
1020138Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
087d7774-9b0f-44f6-bc1b-4dfbd2f2f6caAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
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
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-819-26tussin dm max daytime nighttime118 mL in 1 BOTTLESOLUTION118 mL20 mg in 20mL4
69842-819-26tussin dm118 mL in 1 BOTTLESOLUTION1184
69842-819-26tussin dm1 in 1 CARTONSOLUTION14
69842-819-26tussin dm max daytime nighttime1 in 1 CARTONSOLUTION400 mg in 20mL4
69842-819-34tussin dm1 in 1 CARTONSOLUTION14
69842-819-34tussin dm237 mL in 1 BOTTLESOLUTION2374

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69842-819-26ML - Milliliter69842-81944a8956d-7080-4115-bfb8-cf75b2baa09212020-03-10
69842-819-34ML - Milliliter69842-81993e369fb-684d-42ea-ab87-8b8cde1ac82e12020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-819TUSSIN DM MAX DAYTIME NIGHTTIME (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFESESIN) KIT [CVS PHARMACY]4Current NDC, Legacy NDC20241218_6feaf29e-de06-4c94-912c-a76ea2cbd8c1.zip
69842-819TUSSIN DM (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [CVS PHARMACY]3Current NDC, Legacy NDC, 4 package rows20241011_087d7774-9b0f-44f6-bc1b-4dfbd2f2f6ca.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 1 of 195 · 3,895 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRGeiss, Destin & Dunn Inc.1ea07a01-8779-48c2-a287-b7be866cce7b2026-09-10WarningsExact identifier
application number: M012
Childrens Cold and Allergy ReliefBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCLStrategic Sourcing Services LLCd64fe757-9948-4727-b5dd-1f8e4e4763e22026-09-10WarningsExact identifier
application number: M012
Cold and Flu HBPACETAMINOPHEN, CHLORPHENIRAMINE MALEATEKroger Companyfd41e4a4-330f-4409-8ba3-0b3bb6f45bca2026-09-10WarningsExact identifier
application number: M012
Nighttime Sleep Aid Berry FlavorDIPHENHYDRAMINE HYDROCHLORIDERaritan Pharmaceuticals Inc303d7651-9c8f-4a14-9f2c-7181fa0f003e2026-09-09WarningsExact identifier
application number: M012
DRx Choice Fruit PunchGUAIFENESINRaritan Pharmaceuticals Inca19d7e1c-c04e-41c6-8af6-ecde962992162026-09-09WarningsExact identifier
application number: M012
Mucus Relief Cold Flu and Sore Throat Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRaritan Pharmaceuticals Inc2cb3e17f-3858-4773-a53f-0860ae6ff1b92026-09-09WarningsExact identifier
application number: M012
MUCINEX FAST-MAX Liquid Gels Day Night Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATEReckitt Benckiser LLC3856c1e4-814f-85c4-e063-6394a90ab8a82026-09-09WarningsExact identifier
application number: M012
DRx Choice Long Acting CoughDEXTROMETHORPHAN HBRRARITAN PHARMACEUTICALS875b40bd-7955-4048-abbf-7f43d9ea3ac52026-09-09WarningsExact identifier
application number: M012
severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDERite Aid Corporation4b8ae971-ab57-4937-a878-72d905d7b8492026-09-09WarningsExact identifier
application number: M012
Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCARDINAL HEALTH 110, LLC. DBA LEADER 7000082ba9a73-60ef-49fd-960f-5ca2bb79555e2026-09-09WarningsExact identifier
application number: M012
Mucus Relief DMDEXTROMETHORPHAN HYDROBROMIDE GUAIFENESINThe Kroger Co.49829083-5c0a-4620-bfb3-7103642368db2026-09-09WarningsExact identifier
application number: M012
DRx Choice Childrens Stuffy Nose and Chest CongestionGUAIFENESIN AND PHENYLEPHRINE HCLRARITAN PHARMACEUTICALS7a3bb739-ff50-4d29-b270-d6b0849064932026-09-09WarningsExact identifier
application number: M012
DRx Choice Children daytime Cough and Chest CongestionDEXTROMETHORPHAN HBR AND GUAIFENESINRARITAN PHARMACEUTICALS25fff2a6-ecb1-4117-bd11-e5ec3e3d09a92026-09-09WarningsExact identifier
application number: M012
Mucus Relief Severe Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRaritan Pharmaceuticals Inc8a166067-b492-4742-b74c-28fac87c8d702026-09-09WarningsExact identifier
application number: M012
DRx Choice maximum strength Severe Cough plus sore throatACETAMINOPHEN, DEXTROMETHORPHAN HBRRARITAN PHARMACEUTICALSa096cb76-0d1c-4ca8-854a-5199da0bc8f72026-09-09WarningsExact identifier
application number: M012
Vicks DayQuil VapoCOOL SEVERE COLD and FLU plus CONGESTIONACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Companyefb69cc1-a745-6efc-e053-2a95a90abdc92026-09-08WarningsExact identifier
application number: M012
Vicks NyQuil VapoCOOL Severe COLD and FLU plus CONGESTIONACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDEThe Procter & Gamble Manufacturing Companyefb5f0b9-9825-ab23-e053-2995a90a26ab2026-09-08WarningsExact identifier
application number: M012
Vicks DayQuil and Nyquil VapoCOOL Severe COLD and FLU plus CONGESTIONACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATEThe Procter & Gamble Manufacturing Companyf4328b44-cdfa-41aa-e053-2995a90a27282026-09-08WarningsExact identifier
application number: M012
Vicks childrens Cough CongestionPHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, GUAIFENESINThe Procter & Gamble Manufacturing Companye2356457-9791-3710-e053-2995a90ad1402026-09-08WarningsExact identifier
application number: M012
Cold Multi-SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLWal-Mart Stores Inc077fac1a-0ec5-40d9-8861-a281b48f650a2026-09-08WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2056073{1 (dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Solution) / 1 (dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral Solution) } PackGPCK6feaf29e-de06-4c94-912c-a76ea2cbd8c14
20560731 daytime (dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral Solution) / 1 nighttime (dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral Solution) PackPSN6feaf29e-de06-4c94-912c-a76ea2cbd8c14
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSN087d7774-9b0f-44f6-bc1b-4dfbd2f2f6ca4
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSN6feaf29e-de06-4c94-912c-a76ea2cbd8c14
1115329dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral SolutionPSN6feaf29e-de06-4c94-912c-a76ea2cbd8c14
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD087d7774-9b0f-44f6-bc1b-4dfbd2f2f6ca4
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD6feaf29e-de06-4c94-912c-a76ea2cbd8c14
1115329dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral SolutionSCD6feaf29e-de06-4c94-912c-a76ea2cbd8c14
20560731 daytime (dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral Solution) / 1 nighttime (dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral Solution) PackSY6feaf29e-de06-4c94-912c-a76ea2cbd8c14
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSY087d7774-9b0f-44f6-bc1b-4dfbd2f2f6ca4
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSY6feaf29e-de06-4c94-912c-a76ea2cbd8c14
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY087d7774-9b0f-44f6-bc1b-4dfbd2f2f6ca4
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY6feaf29e-de06-4c94-912c-a76ea2cbd8c14
1115329dextromethorphan hydrobromide 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral SolutionSY6feaf29e-de06-4c94-912c-a76ea2cbd8c14
1115329dextromethorphan hydrobromide 7.5 MG / doxylamine succinate 3.125 MG per 5 ML Oral SolutionSY6feaf29e-de06-4c94-912c-a76ea2cbd8c14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-819-26698420819261 BOTTLE in 1 CARTON (69842-819-26) / 118 mL in 1 BOTTLE1 bottle2018-05-040000-00-00NoNoCurrent
69842-819-34698420819341 BOTTLE in 1 CARTON (69842-819-34) > 237 mL in 1 BOTTLE1 bottle2018-05-040000-00-00NoNoCurrent