FDA.reportPublic FDA data

Foster and Thrive Chest Congestion Relief DM

Product NDC
70677-1055
11-digit product format
706771055
Labeler code
70677
Product ID
70677-1055_799ac1fa-1258-4240-b0aa-32121504b6ee
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan Hydrobromide / Guaifenesin
Dosage form
TABLET
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-01-27
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
20; 400 mg/1; mg/1
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

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 Chest Congestion Relief DM
Brand name suffix
DM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE20 mg/1
GUAIFENESIN400 mg/1

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
1147685Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5372f764-985e-4a42-bc97-cb0dc90fcd9cAvailable 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
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
70677-1055-1Foster and Thrive Chest Congestion Relief DMDM1 in 1 CARTONTABLET13
70677-1055-1Foster and Thrive Chest Congestion Relief DMDM50 in 1 BOTTLETABLET503

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1055-1EA - Each70677-1055ed67222b-278e-4996-93fe-72d2e32b606c12023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1055FOSTER AND THRIVE CHEST CONGESTION RELIEF DM DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [STRATEGIC SOURCING SERVICES LLC]3Current NDC, 2 package rows20241220_5372f764-985e-4a42-bc97-cb0dc90fcd9c.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 115 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BenadrylDIPHENHYDRAMINE HYDROCHLORIDEMorning Star OTCf4ff84b3-bb0c-4900-8ba4-6d1b903947822025-06-09WarningsExact identifier
application number: M012
Equate Kids Daytime Dex Cough GelsDEXTROMETHORPHANWalmart37269cd6-1528-9879-e063-6394a90a2b542025-06-09WarningsExact identifier
application number: M012
Nuvicare DayTime Cold and Flu SoftgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDENUVICARE LLCbdc35570-c8df-4797-a13e-7f2479ec42b72025-06-09WarningsExact identifier
application number: M012
Nuvicare DayTime and NightTime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATENUVICARE LLCf5764925-c586-40e4-8252-24d92389af012025-06-09WarningsExact identifier
application number: M012
Nuvicare NightTime Cold and Flu SoftgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATENUVICARE LLC2a29f0ed-d86b-4787-84e0-f7a8c5e7581f2025-06-09WarningsExact identifier
application number: M012
Nuvicare DayTime and NightTime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATENUVICARE LLC7fa8e4ad-95cb-4905-90db-d53b3bc87c412025-06-09WarningsExact identifier
application number: M012
Vaporizing Steam LiquidMEDICATED COUGH SUPPRESSANTNeilMed Pharmaceuticals Inc.36cf6218-adb8-9d8b-e063-6394a90a49a02025-06-05WarningsExact identifier
application number: M012
Geri-Tussin DMDEXTROMETHORPHAN HBR, GUAIFENESINGeri-Care Pharmaceuticals, Corp7e2fb43c-a7f1-4c1d-a700-7c6510999c032025-06-05WarningsExact identifier
application number: M012
CHILDRENS ROBITUSSIN COUGH AND COLD LONG-ACTINGCHLORPHENIRAMINE MALEATE, DEXTROMETRORPHAN HBRHaleon US Holdings LLCbecb4025-b63e-f2ea-9d11-d51fdf4e5c132025-06-04WarningsExact identifier
application number: M012
Diphenhydramine HCL STRAWBERRY FLAVORDIPHENHYDRAMINE HCLInnovida Pharmaeutique Corporation7eb709a5-c587-4f1d-bc2d-576d07a3a3bf2025-06-04WarningsExact identifier
application number: M012
Children Allergy Relief Bubblegum flavorDIPHENHYDRAMINE HCLTARGET CORPORATION69d33f77-06e1-48fa-a516-892fdf11bb1c2025-06-03WarningsExact identifier
application number: M012
oxymetazoline hydrochlorideOXYMETAZOLINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.fd058e2b-5445-e416-e053-6394a90a611b2025-06-03WarningsExact identifier
application number: M012
Major Nasal DecongestantOXYMETAZOLINE HYDROCHLORIDENuCare Pharmaceuticals, Inc.36b1a7e0-c8b9-0890-e063-6394a90ab13a2025-06-03WarningsExact identifier
application number: M012
COLD, FLU and SORE THROAT RELIEFACETAMINOPHEN 650 MG, DEXTROMETHORPHAN HBR 20 MG, GUAIFENESIN 400 MG, PHENYLEPHRINE HCL 10 MGBETTER LIVING BRANDS, LLC202d60a8-83da-5afc-e063-6394a90ad7792025-05-31WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLTARGET CORPORATIONf935341f-1e33-d78e-e053-6294a90a348e2025-05-30WarningsExact identifier
application number: M012
Diphenhydramine HClDIPHENHYDRAMINE HCLAARNA USA INC.365bb414-8425-a900-e063-6394a90aa8872025-05-30WarningsExact identifier
application number: M012
Childrens AllergyDIPHENHYDRAMINE HYDROCHLORIDEP & L Development, LLC8559be55-8b00-4353-8e26-b5dff2ada8062025-05-30WarningsExact identifier
application number: M012
Daytime Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEWalmart Inc.35da8429-1f83-9e81-e063-6294a90a35152025-05-23WarningsExact identifier
application number: M012
MAXIMUM STRENGTH COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTARGET CORP9dfef3dc-dbc8-659a-e053-2995a90a8c3b2025-05-21WarningsExact identifier
application number: M012
Adult TussinGUAIFENESINCamber Consumer Care896d2540-279a-4405-b176-acbff56303e52025-05-20WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1147685dextromethorphan HBr 20 MG / guaiFENesin 400 MG Oral TabletPSN5372f764-985e-4a42-bc97-cb0dc90fcd9c3
1147685dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral TabletSCD5372f764-985e-4a42-bc97-cb0dc90fcd9c3
1147685guaifenesin 400 MG / dextromethorphan HBr 20 MG Oral TabletSY5372f764-985e-4a42-bc97-cb0dc90fcd9c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70677-1055-1706771055011 BOTTLE in 1 CARTON (70677-1055-1) / 50 TABLET in 1 BOTTLE1 bottle2024-12-18NoNoCurrent