FDA.reportPublic FDA data

NDC 50269-101 - THERAFLU SEVERE COLD RELIEF NIGHTTIME

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
50269-101
Package NDCs from labels
50269-101-06
Manufacturer
JC World Bell Wholesale Co., Inc.
Effective date
2024-05-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
THERAFLU SEVERE COLD RELIEF NIGHTTIME, Honey (Honey Lemon Flavor)JC World Bell Wholesale Co., Inc.2024-05-22HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50269-101-06THERAFLU SEVERE COLD RELIEF NIGHTTIME1 in 1 PACKETPOWDER, FOR SOLUTION11
50269-101-06THERAFLU SEVERE COLD RELIEF NIGHTTIME20 in 1 BOXPOWDER, FOR SOLUTION201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50269-101THERAFLU SEVERE COLD RELIEF NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) POWDER, FOR SOLUTION [JC WORLD BELL WHOLESALE CO., INC.]12 package rows20240523_6ee1cc52-2d7e-4b53-a0e6-563e623bcb51.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 209 of 329 · 6,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
good sense pain reliefACETAMINOPHENPreferred Pharmaceuticals Inc.523b68da-cd2a-4960-95e7-de5d51ce33c12025-01-23WarningsExact identifier
unii: 362O9ITL9D
DOCTRUST K ToothSILICON DIOXIDE, SODIUM MONOFLUOROPHOSPHATEDOCSMEDI Co., Ltd.a02f8865-e7be-4ef4-b09c-dad8466397642025-01-22WarningsExact identifier
unii: ETJ7Z6XBU4
Acetaminophen and Codeine PhosphateACETAMINOPHEN AND CODEINE PHOSPHATEDirect_Rxe78e50c0-36da-528e-e053-2995a90a3d802025-01-22Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENDirect_Rxe8a7c995-e473-ca87-e053-2995a90a5b802025-01-22Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
HYDROCODONE/APAPHYDROCODONE/APAPDirect_Rxefe3b2eb-5c26-3783-e053-2995a90a6ba82025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
PercocetOXYCODONE/APAPDirect_Rxee151649-b52a-0a51-e053-2a95a90a6c352025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
NorcoHYDROCODONE/APAPDirect_Rxee248dfd-7aa7-7dcc-e053-2995a90af19f2025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Hydrocodone/APAPHYDROCODONE/APAPDirect_Rxf0e66441-668a-7ab8-e053-2995a90aba4f2025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Lemon QuinceLEMON QUINCEUriel Pharmacy Inc332e4a40-e0f3-11de-8a39-0800200c9a662025-01-22WarningsExact identifier
unii: ETJ7Z6XBU4
Anise PyriteANISE PYRITEUriel Pharmacy Inc.a03cdeb0-8347-40cc-8d17-5510d99575c72025-01-22WarningsExact identifier
unii: C151H8M554
Childrens Allergy ReliefDIPHENHYDRAMINE HCLBest Choice0035e6a4-b3ef-4e0b-aa7f-7453dd065f4d2025-01-22WarningsExact identifier
application number: M012
unii: TC2D6JAD40
GOOD REMEDIES Allergy Relief SOFTGELDIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Inc.26a02737-2cfd-769f-e063-6394a90af3522025-01-22WarningsExact identifier
application number: M012
unii: TC2D6JAD40
ACD ADEXTROSE MONOHYDRATE, SODIUM CITRATE, AND CITRIC ACID MONOHYDRATETerumo BCT Ltd570770de-9b48-4fc1-a1ee-06002ca9504f2025-01-22Exact identifier
unii: 1Q73Q2JULR
Nuby Soothing GelSOOTHING GELNINGBO RAFFINI IMPORTS & EXPORTS CO LTD290692c0-54d9-d401-e063-6294a90a705a2025-01-21WarningsExact identifier
unii: 91D9GV0Z28
Anticoagulant Citrate Dextrose (ACD-A)DEXTROSE MONOHYDRATE, SODIUM CITRATE, UNSPECIFIED FORM, AND CITRIC ACID MONOHYDRATETerumo BCT, Ltd0130d7c8-d067-4528-beb7-166559c33be92025-01-21Warnings, Adverse reactionsExact identifier
unii: 1Q73Q2JULR
PHARBEDRYLDIPHENHYDRAMINE HCL 50MGUlai Health LLC135293fb-5674-4638-be55-b968cf51257e2025-01-20WarningsExact identifier
unii: TC2D6JAD40
PharbetolACETAMINOPHEN 325 MGUlai Health LLC55bb7e6c-e98c-48bd-b7bb-9848ff0273ca2025-01-20WarningsExact identifier
unii: 362O9ITL9D
PharbechlorCHLORPHENIRAMINE MALEATE 4MGUlai Health LLC6a1a5cef-e946-4ba8-9402-557c6adf45f92025-01-20WarningsExact identifier
application number: M012
ACETAMINOPHEN PMACETAMINOPHEN 500MG / DIPHENHYDRAMINE HCL 25MGUlai Health LLCd4a568c9-a721-48d1-aebc-fc65444947ce2025-01-20WarningsExact identifier
unii: TC2D6JAD40
unii: 362O9ITL9D
PharbinexGUAIFENESIN 400MGUlai Health LLC4eafa81a-aeee-4c97-85d6-594902b109192025-01-20Exact identifier
application number: M012

Reported adverse events (FAERS/openFDA)#

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