FDA.reportPublic FDA data

Foster and Thrive Chest Congestion Relief PE

Product NDC
70677-1056
11-digit product format
706771056
Labeler code
70677
Product ID
70677-1056_92cb8776-6883-4055-9073-17db1a91e71b
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin/phenylephrine
Dosage form
TABLET
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-01-27
Substance
GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
400; 10 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70677-1056-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70677-1056-1f5e01cc5f278…a2eaf40c39c3…

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 PE
Brand name suffix
PE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUAIFENESIN400 mg/1
PHENYLEPHRINE HYDROCHLORIDE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
495W7451VQInternal UNII lookup
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1304111Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3429aedc-e83d-498a-bfca-03aaf5847b3bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-1056-1Foster and Thrive Chest Congestion Relief PEPE50 in 1 BOTTLETABLET5010
70677-1056-1Foster and Thrive Chest Congestion Relief PEPE1 in 1 CARTONTABLET110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1056-1EA - Each70677-1056242fbb75-9cb9-46e7-a6b7-05aa23640cf912023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1056FOSTER AND THRIVE CHEST CONGESTION RELIEF PE PE (GUAIFENESIN/PHENYLEPHRINE) TABLET [<TEXT XMLNS="URN:HL7-ORG:V3"> <PARAGRAPH> <CONTENT STYLECODE="BOLD">ACTIVE INGREDIENT</CONTENT> - (PER TABLET)<BR/> <BR/>DEXTROMETHORPHAN HYDROBROMIDE 20MG<BR/> <BR/>GUAIFENESIN 400MG<BR/> </PARAGRAPH> <PARAGRAPH/></TEXT>]8Current NDC, 2 package rows20241225_3429aedc-e83d-498a-bfca-03aaf5847b3b.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 63 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Conex PediatricDEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCLLlorens Pharmaceutical International Division2a46af43-ef36-e14e-e063-6394a90a82852025-12-31WarningsExact identifier
application number: M012
ConexDEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCLLlorens Pharmaceutical International Division2a343656-ac6d-8b20-e063-6294a90ab3192025-12-31WarningsExact identifier
application number: M012
Dologesic NFACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATELlorens Pharmaceutical International Division974fc0d5-7a99-46fb-af38-b91240f728fa2025-12-31WarningsExact identifier
application number: M012
Dologesic DFACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATELlorens Pharmaceutical International Division55768b45-fd98-4779-85b6-6a50c628677e2025-12-31WarningsExact identifier
application number: M012
TriponelDEXTROMETHORPHAN HBR, PSEUFOEPHEDRINE HCL, TRIPROLIDINE HCLLlorens Pharmaceutical International Division, Inc.e9a8deb4-0595-4f0f-ac15-f936f15aca882025-12-31WarningsExact identifier
application number: M012
TusnelDEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCLLlorens Pharmaceutical International Division805dc611-355a-4af5-bf19-464c3290c5c62025-12-31WarningsExact identifier
application number: M012
Tusnel PediatricDEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCLLlorens Pharmaceutical International Division82f447f6-4f1b-4f56-9d7d-ea02adeea88c2025-12-31WarningsExact identifier
application number: M012
TriponelDEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCLLLORENS PHARMACEUTICALS INTERNATIONAL DIVISIONcc774d33-96ce-4992-ad30-3cb03b0d119d2025-12-31WarningsExact identifier
application number: M012
Tusnel SFDEXTROMETHORPHAN HBR, GUAIFENESINLlorens Pharmaceutical International Division, Inc.cb43b4df-5ccc-416e-abcd-98f079b3f2bb2025-12-31WarningsExact identifier
application number: M012
Tusnel Cough Suppressant ExpectorantDEXTROMETHORPHAN HBR, GUAIFENESINLlorens Pharmaceutical International Division, Inc.af71cdbc-33d6-4303-b494-d7321721d3be2025-12-31WarningsExact identifier
application number: M012
Tusnel Pediatric DMDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLLlorens Pharmaceutical International Division, Inc.63541753-de8d-42fe-a9b3-a5eac3fcdca42025-12-31WarningsExact identifier
application number: M012
Tusnel Pediatric DropsGUAIFENESIN, PHENYLEPHRINE HCLLLORENS PHARMACEUTICALS INTERNATIONAL DIVISIONdbf7c43a-7b29-4c70-9e6d-8a7ea924a9d72025-12-31WarningsExact identifier
application number: M012
Tusnel DM PediatricDEXTROMETHORPHAN, GUIAFENESIN, PSEUDOEPHEDRINE HCLLlorens Pharmaceutical International Divisiond915eab8-013e-4ce3-b358-0d531e5ca1ba2025-12-31WarningsExact identifier
application number: M012
Tusnel-DM PediatricDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLLLORENS PHARMACEUTICALS INTERNATIONAL DIVISION64e36b02-b5be-4d20-8818-cb5b235966712025-12-31WarningsExact identifier
application number: M012
Honey Lemon Cough DropsMENTHOLBestco Inc.77f89a64-f4a4-f909-e053-2a91aa0ad44d2025-12-31WarningsExact identifier
application number: M012
Honey Lemon Cough DropsMENTHOLBestco Inc.77f65f59-7ea1-adce-e053-2991aa0a6f1f2025-12-31WarningsExact identifier
application number: M012
Sugar Free Honey Lemon Cough DropsMENTHOLBestco Inc.77f9e176-d87a-beed-e053-2991aa0aac202025-12-31WarningsExact identifier
application number: M012
Sugar Free Cherry Cough DropsMENTHOLBestco Inc.7858f380-bef7-3d30-e053-2a91aa0a7ea62025-12-31WarningsExact identifier
application number: M012
Strawberry Cough DropsMENTHOLBestCo Inc.26a22cfd-395b-4ffb-e054-00144ff88e882025-12-31WarningsExact identifier
application number: M012
Limpia PechoDEXTROMETHORPHAN HBR, GUAIFENESINLlorens Pharmaceutical International Division, Inc.cbaea3e4-4c4b-4ff9-ae6f-95b6a2d3faf32025-12-31WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1304111guaiFENesin 400 MG / phenylephrine HCl 10 MG Oral TabletPSN3429aedc-e83d-498a-bfca-03aaf5847b3b10
1304111guaifenesin 400 MG / phenylephrine hydrochloride 10 MG Oral TabletSCD3429aedc-e83d-498a-bfca-03aaf5847b3b10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70677-1056-1706771056011 BOTTLE in 1 CARTON (70677-1056-1) / 50 TABLET in 1 BOTTLE1 bottle2024-12-18NoNoCurrent