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 40 of 342 · 6,831 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
dual actionACETAMINOPHEN, IBUPROFENPublix Super Markets Ince185d119-3484-40b1-afb8-6dca49d45e402026-06-04WarningsExact identifier
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENASCLEMED USA INC.707a9ea7-8f4e-4274-97bd-b8071a0ee06b2026-06-04WarningsExact identifier
unii: 362O9ITL9D
MedlineACETAMINOPHENMedline Industries, LPfc5e6f2a-e813-0666-e053-6394a90a66a72026-06-04WarningsExact identifier
unii: 362O9ITL9D
MedlineACETAMINOPHENMedline Industries, LPfc5d92c2-4bbe-8ad1-e053-6294a90a65b62026-06-04WarningsExact identifier
unii: 362O9ITL9D
Mucinex Fast-Max DM Max and Mucinex Fast-Max Nighttime DM Max Value PackDEXTROMETHORPHAN HBR, GUAIFENESIN AND TRIPROLIDINE HCLReckitt Benckiser LLC4df37cfb-299f-661f-e063-6394a90ab3372026-06-04WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold Flu Congestion Severe Fast Hot Liquid Day NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATEBayer HealthCare LLC.53715ea4-42b3-5887-e063-6294a90a42492026-06-04WarningsExact identifier
application number: M012
acetaminophenACETAMINOPHENUnit Dose Solutions, Inc.537219ac-552a-a30e-e063-6394a90aa9d12026-06-04WarningsExact identifier
unii: 362O9ITL9D
ACETAMINOPHEN AND CODEINE PHOSPHATEACETAMINOPHEN AND CODEINE PHOSPHATEUnit Dose Solutions, Inc.537245e8-5e2a-c3e0-e063-6394a90ac8582026-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
dual pain relieverACETAMINOPHEN, IBUPROFENMeijer, Inc.db1dc4f6-23ec-4a04-baa8-ffa739bce76a2026-06-04WarningsExact identifier
unii: 362O9ITL9D
DUAL ACTIONACETAMINOPHEN, IBUPROFENAmazon.com Services LLC20fe6b3f-e5a6-47d4-a371-9172408fbc462026-06-04WarningsExact identifier
unii: 362O9ITL9D
Tussin DMDEXTROMETHORPHAN HBR, GUAIFENESINChain Drug Marketing Association, Inc.b0d38db9-22a9-4dd8-8e0f-dd81805e724b2026-06-04WarningsExact identifier
application number: M012
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRCVS PHARMACY65d4d7ea-c080-404e-9836-7d6bdcc5ea7d2026-06-04WarningsExact identifier
application number: M012
Pain Relief childrensACETAMINOPHENCVS PHARMACYff878f56-125a-4de7-b063-029f7030733d2026-06-04WarningsExact identifier
unii: 362O9ITL9D
acetaminophen and ibuprofenACETAMINOPHEN, IBUPROFENKroger Companye6c0cca6-812e-4bea-86b0-e15b10f3f0d42026-06-04WarningsExact identifier
unii: 362O9ITL9D
topcare dual actionACETAMINOPHEN, IBUPROFENTopco Associates LLCdddc04c4-d500-4d42-8406-89f27a9ad6512026-06-04WarningsExact identifier
unii: 362O9ITL9D
Allergy Relief ChildrensDIPHENHYDRAMINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDfe9d6a6e-38a1-44ae-a30f-596c5ec7d0572026-06-03WarningsExact identifier
application number: M012
unii: TC2D6JAD40
Childrens MapapACETAMINOPHENMajor Pharmaceuticalsefec6af2-8b26-47f6-88c8-b0a6d69a2d7d2026-06-03WarningsExact identifier
unii: 362O9ITL9D
Acetaminophen PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLUnited Natural Foods, Inc. dba UNFIae3114c3-8cfe-4b81-8ac7-c281fe68b4622026-06-03WarningsExact identifier
unii: TC2D6JAD40
unii: 362O9ITL9D
AcetaminophenACETAMINOPHENCOSTCO WHOLESALE CORPORATION3745aa18-a711-43ed-9bc4-1f087b3c53c02026-06-03WarningsExact identifier
unii: 362O9ITL9D
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLC3f653262-b931-7d42-e063-6394a90adddd2026-06-03WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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