FDA.reportPublic FDA data

Tussin DM

Product NDC
69842-699
11-digit product format
698420699
Labeler code
69842
Product ID
69842-699_faf0eaea-ff1c-411f-b7ad-f0362d7d9b32
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Doxylamine succinate
Dosage form
SOLUTION
Route
ORAL
Labeler
CVS Pharmacy
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-06-25
Substance
DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength
30; 12.5 mg/20mL; mg/20mL
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA], 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 HYDROBROMIDE30 mg/20mL
DOXYLAMINE SUCCINATE12.5 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
V9BI9B5YI2Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1115329Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fc1e224c-5c57-43fc-ae6e-36aa0a4ae439Available 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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
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
69842-699-26Tussin DM1 in 1 CARTONSOLUTION15
69842-699-26Tussin DM118 mL in 1 BOTTLESOLUTION1185
69842-699-26tussin dm max daytime nighttime1 in 1 CARTONSOLUTION30 mg in 20mL4
69842-699-26tussin dm max daytime nighttime118 mL in 1 BOTTLESOLUTION118 mL12.5 mg in 20mL4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-699TUSSIN DM (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [CVS PHARMACY]4Current NDC, Legacy NDC, 2 package rows20241120_fc1e224c-5c57-43fc-ae6e-36aa0a4ae439.zip
69842-699TUSSIN DM MAX DAYTIME NIGHTTIME (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFESESIN) KIT [CVS PHARMACY]4Current NDC, Legacy NDC20241218_6feaf29e-de06-4c94-912c-a76ea2cbd8c1.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 50 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDELEADER/ Cardinal Health 110, Inc.e33cbd1d-1848-145a-e053-2995a90aeb502026-02-20WarningsExact identifier
application number: M012
Head Congestion and Flu Severe ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporation416080a9-e817-485b-a4ae-6c9d0152c1652026-02-20WarningsExact identifier
application number: M012
Walmart Dye Free Chidrens Allergy ChewsDIPHENHYDRAMINE HCLWALMART STORES INC18436026-b0e4-4481-a647-d735a27d0b002026-02-19WarningsExact identifier
application number: M012
VaporizingCAMPHORMeijer, Inc.7afc98d7-f64f-42d5-9022-28ad6b01db8a2026-02-19Warnings, Adverse reactionsExact identifier
application number: M012
CHILDRENS COLD AND COUGHBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEKroger Company8196b482-070e-4d7d-8943-129141f926ee2026-02-19WarningsExact identifier
application number: M012
Walmart Dye Free Chidrens Allergy Chews BubblegumDIPHENHYDRAMINE HCLWALMART STORES INC9f83d2f0-9718-4f2b-bc7f-e29ba29174122026-02-19WarningsExact identifier
application number: M012
tussin dm maxDEXTROMETHORPHAN HBR, GUAIFENESINKroger Companybe9aaf66-6c59-4042-88e2-acd920dcf9922026-02-19WarningsExact identifier
application number: M012
Allergy Relief Dye-FreeDIPHENHYDRAMINE HCLCVS Pharmacy08459cf4-feb3-4283-88e1-d61e030c57f92026-02-19WarningsExact identifier
application number: M012
allergy reliefCHLORPHENIRAMINE MALEATERite Aid Corporationb0d70488-ea1d-4c1d-bd07-53dfb0e4d03c2026-02-18WarningsExact identifier
application number: M012
Walgreens Wild Cherry Pectin Throat DropsPECTINWalgreens424fda2d-c1e5-0ed9-e063-6394a90a06ea2026-02-18WarningsExact identifier
application number: M012
cough suppressant and topical analgesicCAMPHOR, EUCALYPTUS OIL, MENTHOLTarget Corporationdf21d9d6-36a9-49cf-a29c-c4a573899bd52026-02-18Warnings, Adverse reactionsExact identifier
application number: M012
Allergy ReliefCHLORPHENIRAMINE MALEATEAmerisource Bergeneeda80ff-212d-428e-a0c6-782f271357b42026-02-18WarningsExact identifier
application number: M012
good sense night timeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEL. Perrigo Companye47dffdf-5778-4804-8ce2-54c5a72bba3a2026-02-18WarningsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLUnited Natural Foods, Inc. dba UNFIb139e7d6-bf4d-45b9-b7cf-d34e5352095c2026-02-17Warnings, Adverse reactionsExact identifier
application number: M012
Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLStrategic Sourcing Services LLCbd54bf7a-2304-4c3f-9cd2-bafea217466e2026-02-17Warnings, Adverse reactionsExact identifier
application number: M012
Creomulsion For ChildrenDEXTROMETHORPHAN HYDROBROMIDESocius Care, LLC39d0e96c-1cc3-4961-e054-00144ff88e882026-02-17WarningsExact identifier
application number: M012
Creomulsion Cough Medicine Adult FormulaDEXTROMETHORPHAN HYDROBROMIDESocius Care, LLC39d07486-99b7-5c06-e054-00144ff8d46c2026-02-17WarningsExact identifier
application number: M012
Cold and Flu Severe, Day, NightACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR. GUAIFENESIN, PHENYLEPHRINE HCLL.N.K. International, Inc.6e6bae79-1231-4b74-81c1-f0c914ed4af32026-02-17WarningsExact identifier
application number: M012
COUGH AND CHEST CONGESTIONDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDdfe69c12-b5fe-46d1-a3bf-ef3729c2e7862026-02-17WarningsExact identifier
application number: M012
NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED3fb49f64-2d77-44db-8186-5904837eedbe2026-02-17WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115329dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral SolutionPSNfc1e224c-5c57-43fc-ae6e-36aa0a4ae4395
1115329dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral SolutionSCDfc1e224c-5c57-43fc-ae6e-36aa0a4ae4395
1115329dextromethorphan hydrobromide 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral SolutionSYfc1e224c-5c57-43fc-ae6e-36aa0a4ae4395
1115329dextromethorphan hydrobromide 7.5 MG / doxylamine succinate 3.125 MG per 5 ML Oral SolutionSYfc1e224c-5c57-43fc-ae6e-36aa0a4ae4395
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 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 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 SolutionSY6feaf29e-de06-4c94-912c-a76ea2cbd8c14
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
69842-699-26698420699261 BOTTLE in 1 CARTON (69842-699-26) / 118 mL in 1 BOTTLE1 bottle2018-06-250000-00-00NoNoCurrent