FDA.reportPublic FDA data

Tussin DM

Product NDC
51316-304
11-digit product format
513160304
Labeler code
51316
Product ID
51316-304_47e16140-8df7-4dc1-a0e5-57755aeb68cc
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin
Dosage form
SOLUTION
Route
ORAL
Labeler
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-04-18
Marketing end
2028-01-31
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
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
Brand name suffix
Daytime

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
432d4833-2eaf-4f7c-b6b4-41043a6b7e2aAvailable 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
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-304-19Tussin DMDaytime237 mL in 1 BOTTLE, PLASTICSOLUTION2376
51316-304-19Tussin DMDaytime1 in 1 CARTONSOLUTION16
51316-304-36Tussin DMDaytime118 mL in 1 BOTTLE, PLASTICSOLUTION1186
51316-304-36Tussin DMDaytime1 in 1 CARTONSOLUTION16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-304TUSSIN DM DAYTIME (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED]5Current NDC, 4 package rows20250207_432d4833-2eaf-4f7c-b6b4-41043a6b7e2a.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 140 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
McKesson Phenylephrine HClPHENYLEPHRINE HCLMcKesson Medical-Surgicale09060f7-ca0b-5f7c-e053-2995a90ab3442024-11-08WarningsExact identifier
application number: M012
daytime severeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDe0e216ef-300c-4f57-87e6-62a5327e09b42024-11-08WarningsExact identifier
application number: M012
basic care daytime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC969c0718-ba6e-4edb-9f55-43bc9500450f2024-11-08WarningsExact identifier
application number: M012
daytime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWalgreen Company62a70d9a-4e78-497c-8f75-012ab94e92f62024-11-08WarningsExact identifier
application number: M012
adult tussin dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINPublix Super Markets Inc25b2ad8a-5835-4496-815f-73a7fb40dcfd2024-11-08WarningsExact identifier
application number: M012
severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDERite Aid Corporation296f20c0-8b5f-4a08-9329-f93c92e638672024-11-08WarningsExact identifier
application number: M012
topcare tussin dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINTopco Associates LLCd3cae69e-41a5-4099-a3f4-ce25fd94df732024-11-08WarningsExact identifier
application number: M012
foster and thrive daytime severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEStrategic Sourcing Services LLC9d147d1e-8ea5-4e0f-8ae8-1da16f1194962024-11-08WarningsExact identifier
application number: M012
equate adult cough and chest congestion dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINWALMART INC.e770bdb2-3662-4538-8199-fe4a4059c7202024-11-08WarningsExact identifier
application number: M012
DG Health Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEDolgencorp Inc23dcb627-c867-435f-9d1a-a9f49e58b58f2024-11-08WarningsExact identifier
application number: M012
good neighbor pharmacy adult tussin DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINAmerisource Bergenced71993-f535-4e28-bc1d-3fcb7d86e9b72024-11-08WarningsExact identifier
application number: M012
adult tussin dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINCVS Pharmacy2f1dc8f8-79c5-4724-99aa-a55330ed9d5f2024-11-08WarningsExact identifier
application number: M012
good sense day time cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEL. Perrigo Company4ac6b64a-8214-4b03-8aa5-0d3199cf0b722024-11-08WarningsExact identifier
application number: M012
tussinDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINH E B1dd9afb6-9b58-4274-a557-900a0cb235242024-11-08WarningsExact identifier
application number: M012
DG health sinus severeOXYMETAZOLINE HYDROCHLORIDEDolgencorp, LLC7abaa912-be8b-463c-8818-104e79b335392024-11-07WarningsExact identifier
application number: M012
Extra Strength TYLENOL Cold Plus Flu Multi-Action DayACETAMINOPHEN, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDEKenvue Brands LLC7d3266dc-879a-4d28-b8ea-74d238c3020a2024-11-07WarningsExact identifier
application number: M012
TYLENOL COLD PLUS FLU SEVERE DAY/NIGHTACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC2ddb86a8-e34c-4a03-a60a-d3fedaf906082024-11-07WarningsExact identifier
application number: M012
Tylenol Cold Plus Head Congestion SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLCce43e5c2-fe96-4462-882c-d7479318b33d2024-11-07WarningsExact identifier
application number: M012
TYLENOL SINUS PLUS HEADACHE DAYACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLCe608d214-cc46-4a24-ac85-1040e36e74032024-11-07WarningsExact identifier
application number: M012
Childrens TYLENOL COLD PLUS COUGH PLUS SORE THROATACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDEKenvue Brands LLCe83f7911-22b4-4ffc-8f49-68f6acd2ebf52024-11-07WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSN432d4833-2eaf-4f7c-b6b4-41043a6b7e2a6
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCD432d4833-2eaf-4f7c-b6b4-41043a6b7e2a6
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSY432d4833-2eaf-4f7c-b6b4-41043a6b7e2a6
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSY432d4833-2eaf-4f7c-b6b4-41043a6b7e2a6
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) } PackGPCKd59f6c64-8311-48ba-90d1-8000b04bfcda4
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) PackPSNd59f6c64-8311-48ba-90d1-8000b04bfcda4
1020138dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral SolutionPSNd59f6c64-8311-48ba-90d1-8000b04bfcda4
1115329dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral SolutionPSNd59f6c64-8311-48ba-90d1-8000b04bfcda4
1020138dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral SolutionSCDd59f6c64-8311-48ba-90d1-8000b04bfcda4
1115329dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral SolutionSCDd59f6c64-8311-48ba-90d1-8000b04bfcda4
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) PackSYd59f6c64-8311-48ba-90d1-8000b04bfcda4
1020138dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral SolutionSYd59f6c64-8311-48ba-90d1-8000b04bfcda4
1020138dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral SolutionSYd59f6c64-8311-48ba-90d1-8000b04bfcda4
1115329dextromethorphan hydrobromide 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral SolutionSYd59f6c64-8311-48ba-90d1-8000b04bfcda4
1115329dextromethorphan hydrobromide 7.5 MG / doxylamine succinate 3.125 MG per 5 ML Oral SolutionSYd59f6c64-8311-48ba-90d1-8000b04bfcda4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51316-304-19513160304191 BOTTLE, PLASTIC in 1 CARTON (51316-304-19) / 237 mL in 1 BOTTLE, PLASTIC2023-04-182028-01-31NoNoHistorical
51316-304-36513160304361 BOTTLE, PLASTIC in 1 CARTON (51316-304-36) / 118 mL in 1 BOTTLE, PLASTIC2023-04-182028-01-31NoNoHistorical