FDA.reportPublic FDA data

foster and thrive adult tussin dm

Product NDC
70677-1035
11-digit product format
706771035
Labeler code
70677
Product ID
70677-1035_8f04e7be-88f6-4ece-b1db-3f17fa1ac312
Type
HUMAN OTC DRUG
Nonproprietary name
dextromethorphan hydrobromide, guaifenesin
Dosage form
SOLUTION
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-25
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
foster and thrive adult tussin dm
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/20mL
GUAIFENESIN200 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
1790650Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f8933226-fbc9-44e3-a90f-4e6c1dbdb7b7Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-1035-1foster and thrive adult tussin dm1 in 1 CARTONSOLUTION12
70677-1035-1foster and thrive adult tussin dm118 mL in 1 BOTTLESOLUTION1182
70677-1035-2foster and thrive adult tussin dm237 mL in 1 BOTTLESOLUTION2372
70677-1035-2foster and thrive adult tussin dm1 in 1 CARTONSOLUTION12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1035-1ML - Milliliter70677-103594b5fbfc-c5a0-4cd1-ba77-58445f2404fa12024-03-12
70677-1035-2ML - Milliliter70677-103592dd0538-9a8a-45e8-bdab-78ad596508a412024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1035FOSTER AND THRIVE ADULT TUSSIN DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [STRATEGIC SOURCING SERVICES LLC]2Current NDC, 4 package rows20241112_f8933226-fbc9-44e3-a90f-4e6c1dbdb7b7.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 117 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sugar Free Honey-Lemon Fishermans Friend Menthol Cough SuppressantMENTHOLLofthouse of Fleetwood, Ltd.87ebb4d9-78d7-1c87-e053-2a95a90adb7d2025-03-27WarningsExact identifier
application number: M012
REVASOL CHILDRENS ALLERGYDIPHENHYDRAMINE HCLRnv LLC3143137f-ef42-5358-e063-6394a90a8ed12025-03-26WarningsExact identifier
application number: M012
Rompe Pecho SF FLUDEXTROMETHORPHAN, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDEEfficient Laboratories Incbc10695a-9664-4ce3-82bb-820da06129fa2025-03-26WarningsExact identifier
application number: M012
SUPRESS-PE PediatricGUIAFENESIN, PHENYLEPHRINE HCLKramer Novisa474171d-5c29-4a80-9d37-00613796211a2025-03-26WarningsExact identifier
application number: M012
Guaifenesin DMDEXTROMETHORPHAN HYDROBROMIDE,GUAIFENESINInnovida Pharmaeutique Corporationdd3f806b-2470-4055-94e1-18adac8110252025-03-25WarningsExact identifier
application number: M012
Foster and Thrive childrens cold cough relief dmBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEStrategic Sourcing Services LLC38b710e3-1d01-4ff4-a6b6-44936f277f492025-03-25WarningsExact identifier
application number: M012
Revasol Tussin DM Max with HoneyDEXTROMETHORPHAN HBR AND GUAIFENESINRnv LLC30da9255-c93a-84d6-e063-6394a90a7c2a2025-03-21WarningsExact identifier
application number: M012
REVASOL NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATERnv LLC30dfd8f7-4cc6-d4f2-e063-6394a90aa9c92025-03-21WarningsExact identifier
application number: M012
Chest Congestion ReliefGUAIFENESINMeijer, Inc.261a79b3-5704-76f2-e063-6394a90a5ac62025-03-20WarningsExact identifier
application number: M012
Rompe Tos X ChildrenACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLOPMX LLC05cc932d-b412-0710-e063-6394a90a87f62025-03-19WarningsExact identifier
application number: M012
Rompe Tos X AdultsACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLOPMX LLC05abb2db-d22e-90b5-e063-6294a90ace3f2025-03-19WarningsExact identifier
application number: M012
Sinus Head CongestionACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEVIVUNT PHARMA LLC30a07773-bd6f-b9f2-e063-6394a90ab8aa2025-03-18WarningsExact identifier
application number: M012
Halls Sugar Free Black CherryMENTHOLMondelez Global LLCbd2a311a-bf0c-4365-af9b-76675c243b222025-03-16WarningsExact identifier
application number: M012
Medicated Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLTARGET CORPORATIONfbca9627-5e12-048a-e053-6294a90a6e0f2025-03-15WarningsExact identifier
application number: M012
Medicated Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLDOLGENCORP, INC.0655688e-7c42-507f-e063-6294a90ae4982025-03-15WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBRCVS PHARMACY, INC1b8d5494-1fcf-4cd0-acc0-34f17d577bd72025-03-14WarningsExact identifier
application number: M012
Ultra Concentrated Daytime COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEPuraCap Pharmaceutical LLC300b2357-933b-fe9a-e063-6294a90aa4b92025-03-11WarningsExact identifier
application number: M012
Ultra Concentrated Nighttime COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEPuraCap Pharmaceutical LLC300bf27f-744f-7366-e063-6394a90acbcb2025-03-11WarningsExact identifier
application number: M012
Daytime COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEPuraCap Pharmaceutical LLC300c7c7b-ea0b-3650-e063-6294a90a65e82025-03-11WarningsExact identifier
application number: M012
Rompe Pecho NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLEFFICIENT LABORATORIES INC2ec319a8-92bf-4552-86dd-37cbce18980f2025-03-11WarningsExact 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 SolutionPSNf8933226-fbc9-44e3-a90f-4e6c1dbdb7b72
1790650dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML Oral SolutionSCDf8933226-fbc9-44e3-a90f-4e6c1dbdb7b72
1790650dextromethorphan HBr 10 MG / guaifenesin 100 MG per 10 ML Oral SolutionSYf8933226-fbc9-44e3-a90f-4e6c1dbdb7b72
1790650dextromethorphan HBr 20 MG / guaifenesin 200 MG per 20 ML Oral SolutionSYf8933226-fbc9-44e3-a90f-4e6c1dbdb7b72
1790650dextromethorphan HBr 5 MG / guaifenesin 50 MG per 5 ML Oral SolutionSYf8933226-fbc9-44e3-a90f-4e6c1dbdb7b72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70677-1035-1706771035011 BOTTLE in 1 CARTON (70677-1035-1) / 118 mL in 1 BOTTLE1 bottle2023-10-25NoNoCurrent
70677-1035-2706771035021 BOTTLE in 1 CARTON (70677-1035-2) / 237 mL in 1 BOTTLE1 bottle2023-10-25NoNoCurrent