FDA.reportPublic FDA data

NDC 10956-791-09 - Refenesen Chest Congestion Relief pe

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
10956-791
Requested NDC
10956-791-09
Package NDCs from labels
10956-791-50, 10956-791-01, 10956-791-09
Manufacturer
Reese Pharmaceutical Co | Contract Pharmacal Corp.
Effective date
2010-12-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
DRUG FACTSReese Pharmaceutical Co | Contract Pharmacal Corp.2010-12-20HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10956-791-012020-01-31C16284748780-19d75b9d0-307f-f424-e053-dadaa90a57ceDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10956-791-01Refenesen Chest Congestion Reliefpe1 in 1 CARTONTABLET11
10956-791-09Refenesen Chest Congestion Reliefpe100 in 1 BOTTLE, PLASTICTABLET1001
10956-791-50Refenesen Chest Congestion Reliefpe50 in 1 BOTTLE, PLASTICTABLET501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10956-791REFENESEN CHEST CONGESTION RELIEF PE (GUAIFENESIN/PHENYLEPHRINE) TABLET [REESE PHARMACEUTICAL CO]1Legacy NDC, 3 package rows20110119_d917dd8c-ee34-4ccc-b192-cafafc73ce22.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10956-791-50EA - Each10956-7919758424c-e3f5-40f8-9344-8387976aa38d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GuaifenesinACTIVE INGREDIENT495W7451VQREFENESEN CHEST CONGESTION RELIEF PE (GUAIFENESIN/PHENYLEPHRINE) TABLET [REESE PHARMACEUTICAL CO]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJREFENESEN CHEST CONGESTION RELIEF PE (GUAIFENESIN/PHENYLEPHRINE) TABLET [REESE PHARMACEUTICAL CO]1
GuaifenesinACTIVE MOIETY495W7451VQREFENESEN CHEST CONGESTION RELIEF PE (GUAIFENESIN/PHENYLEPHRINE) TABLET [REESE PHARMACEUTICAL CO]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVREFENESEN CHEST CONGESTION RELIEF PE (GUAIFENESIN/PHENYLEPHRINE) TABLET [REESE PHARMACEUTICAL CO]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UREFENESEN CHEST CONGESTION RELIEF PE (GUAIFENESIN/PHENYLEPHRINE) TABLET [REESE PHARMACEUTICAL CO]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48REFENESEN CHEST CONGESTION RELIEF PE (GUAIFENESIN/PHENYLEPHRINE) TABLET [REESE PHARMACEUTICAL CO]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GREFENESEN CHEST CONGESTION RELIEF PE (GUAIFENESIN/PHENYLEPHRINE) TABLET [REESE PHARMACEUTICAL CO]1
MAGNESIUM SILICATEINACTIVE INGREDIENT9B9691B2N9REFENESEN CHEST CONGESTION RELIEF PE (GUAIFENESIN/PHENYLEPHRINE) TABLET [REESE PHARMACEUTICAL CO]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30REFENESEN CHEST CONGESTION RELIEF PE (GUAIFENESIN/PHENYLEPHRINE) TABLET [REESE PHARMACEUTICAL CO]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DREFENESEN CHEST CONGESTION RELIEF PE (GUAIFENESIN/PHENYLEPHRINE) TABLET [REESE PHARMACEUTICAL CO]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPREFENESEN CHEST CONGESTION RELIEF PE (GUAIFENESIN/PHENYLEPHRINE) TABLET [REESE PHARMACEUTICAL CO]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EREFENESEN CHEST CONGESTION RELIEF PE (GUAIFENESIN/PHENYLEPHRINE) TABLET [REESE PHARMACEUTICAL CO]1

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 1 of 116 · 2,301 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daytime Sinus SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLKroger Company1022767d-a456-4fbc-95cf-91337c74c3302026-10-01WarningsExact identifier
unii: 04JA59TNSJ
unii: 495W7451VQ
COLTALIN-DMACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEFORTUNE PHARMACAL COMPANY LIMITED33e1bec0-323b-40b7-809a-cb65a71ad0ce2026-09-17WarningsExact identifier
unii: 04JA59TNSJ
Childrens Cold and Allergy ReliefBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCLStrategic Sourcing Services LLCd64fe757-9948-4727-b5dd-1f8e4e4763e22026-09-10WarningsExact identifier
unii: 04JA59TNSJ
DRx Choice Fruit PunchGUAIFENESINRaritan Pharmaceuticals Inca19d7e1c-c04e-41c6-8af6-ecde962992162026-09-09WarningsExact identifier
unii: 495W7451VQ
Mucus Relief Cold Flu and Sore Throat Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRaritan Pharmaceuticals Inc2cb3e17f-3858-4773-a53f-0860ae6ff1b92026-09-09WarningsExact identifier
unii: 04JA59TNSJ
unii: 495W7451VQ
Foster and Thrive Mucus ReliefGUAIFENESINStrategic Sourcing Services LLCf4ab5611-8abb-4c1f-8f85-917e2e1328e32026-09-09WarningsExact identifier
unii: 495W7451VQ
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: FZ989GH94E
Mucus ReliefGUAIFENESINStrategic Sourcing Services LLCcd7955b2-8eee-43d3-973f-6de2f39295122026-09-09WarningsExact identifier
unii: 495W7451VQ
severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDERite Aid Corporation4b8ae971-ab57-4937-a878-72d905d7b8492026-09-09WarningsExact identifier
unii: 04JA59TNSJ
Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCARDINAL HEALTH 110, LLC. DBA LEADER 7000082ba9a73-60ef-49fd-960f-5ca2bb79555e2026-09-09WarningsExact identifier
unii: 04JA59TNSJ
Mucus Relief DMDEXTROMETHORPHAN HYDROBROMIDE GUAIFENESINThe Kroger Co.49829083-5c0a-4620-bfb3-7103642368db2026-09-09WarningsExact identifier
unii: 495W7451VQ
DRx Choice Childrens Stuffy Nose and Chest CongestionGUAIFENESIN AND PHENYLEPHRINE HCLRARITAN PHARMACEUTICALS7a3bb739-ff50-4d29-b270-d6b0849064932026-09-09WarningsExact identifier
unii: 04JA59TNSJ
unii: 495W7451VQ
DRx Choice Children daytime Cough and Chest CongestionDEXTROMETHORPHAN HBR AND GUAIFENESINRARITAN PHARMACEUTICALS25fff2a6-ecb1-4117-bd11-e5ec3e3d09a92026-09-09WarningsExact identifier
unii: 495W7451VQ
Mucus Relief Severe Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRaritan Pharmaceuticals Inc8a166067-b492-4742-b74c-28fac87c8d702026-09-09WarningsExact identifier
unii: 04JA59TNSJ
unii: 495W7451VQ
Maximum Strength Mucus ReliefGUAIFENESINStrategic Sourcing Services LLC5a6f88b8-3436-3321-e063-6294a90a3a2e2026-09-09WarningsExact identifier
unii: 495W7451VQ
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMRite Aid Corporation407c78ca-6fee-4ed6-b61b-711ec049c86e2026-09-09WarningsExact identifier
unii: 04JA59TNSJ
Vicks DayQuil VapoCOOL SEVERE COLD and FLU plus CONGESTIONACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Companyefb69cc1-a745-6efc-e053-2a95a90abdc92026-09-08WarningsExact identifier
unii: 04JA59TNSJ
unii: 495W7451VQ
Vicks NyQuil VapoCOOL Severe COLD and FLU plus CONGESTIONACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDEThe Procter & Gamble Manufacturing Companyefb5f0b9-9825-ab23-e053-2995a90a26ab2026-09-08WarningsExact identifier
unii: 04JA59TNSJ
Vicks childrens Cough CongestionPHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, GUAIFENESINThe Procter & Gamble Manufacturing Companye2356457-9791-3710-e053-2995a90ad1402026-09-08WarningsExact identifier
unii: 04JA59TNSJ
unii: 495W7451VQ
Nighttime Severe Cold and CoughACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINERARITAN PHARMACEUTICALS INC9819155b-2713-42be-867e-16605e7643d02026-09-08WarningsExact identifier
unii: 04JA59TNSJ

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.