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 168 of 336 · 6,715 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Freegells Cough Drops Menthol Cherry 30ctMENTHOLR.L. ALBERT & SON, INCbac77712-6197-4b30-a5f8-9b99eb9d7b5a2025-10-08WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol Cherry 80ctMENTHOLR.L. ALBERT & SON, INC6842d766-ade6-40b2-831b-f4feac25c6db2025-10-08WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol Cherry 80ctMENTHOLRL Albert & Son Inc.9f324ca1-0e2a-47e3-997e-2aaa68a857512025-10-08WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol Honey Lemon 30ctMENTHOLR.L. ALBERT & SON, INC2063a013-aa0b-465d-b04f-cfe2e70d749f2025-10-08WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol Honey Lemon 200ctMENTHOLR.L. ALBERT & SON, INCcd81488c-74d8-48d9-9c73-ff662a5cd4cd2025-10-08WarningsExact identifier
application number: M012
Freegells Cough Drops Menthol Honey Lemon 80ctMENTHOLR.L. ALBERT & SON, INC61deea94-d0a9-4563-926b-53f255a7c4252025-10-08WarningsExact identifier
application number: M012
FREEGELLS COUGH DROPS MENTHOL STRAWBERRY 30 DROPSMENTHOLR.L. ALBERT & SON, INCc6b36350-386b-4346-bef0-a37ec11319c02025-10-08WarningsExact identifier
application number: M012
AcetaminophenACETAMINOPHENPD-Rx Pharmaceuticals, Inc.3f96aeb1-a533-4d36-9a1f-62fc094b67542025-10-08WarningsExact identifier
unii: 362O9ITL9D
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLStrategic Sourcing Services LLC3314b174-d5bb-4843-9288-9b9c5fce79d52025-10-08WarningsExact identifier
application number: M012
unii: TC2D6JAD40
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack96a84a12-da15-410a-9c70-af125f2fcacc2025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENBryant Ranch Prepackb4cf62af-b5d3-4825-9743-9ec3137164e82025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack5d5fa7bb-6416-48dc-95a0-43ffd84cb5952025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENRedPharm Drug, Incfa1b7586-fb26-5e37-e053-6394a90aa92d2025-10-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEWalgreensf2eb9575-d527-44c7-aa5e-efabfd9a02782025-10-07WarningsExact identifier
unii: 362O9ITL9D
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENBryant Ranch Prepack72244b9c-eac4-41c2-8ba6-7302eafba90a2025-10-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Acetaminophen PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLCHAIN DRUG MARKETING ASSOCIATION INCbbc704e5-79f6-4c72-846b-cc30c5c43cb42025-10-07WarningsExact identifier
unii: TC2D6JAD40
unii: 362O9ITL9D
ParathyroparSYMPHYTUM OFFICINALE, BARYTA CARBONICA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, HEKLA LAVA, MANGANUM METALLICUM, RHUS TOX, SILICEA, PARATHORMONUMEnergique, Inc.bd13617a-c470-4421-8f47-43a98036f40b2025-10-06WarningsExact identifier
unii: 91D9GV0Z28
unii: ETJ7Z6XBU4
Mitochondria PROARALIA QUINQUEFOLIA, ARNICA MONTANA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, ASCORBICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CALCAREA CARBONICA, CITRICUM ACIDUM, CUPRUM METALLICUM, CYSTEINUM, FERRUM METALLICUM, IODIUM, LEVOTHYROXINUM, MAGNESIUM GLUCONICUM DIHYDRICUM, MALICUM ACIDUM, MANGANUM ACETICUM, NADIDUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SELENIUM METALLICUM, SULPHUR, THIAMINUM HYDROCHLORICUM, UBIDECARENONUM, ZINCUM METALLICUM,Energique, Inc.8c3e961d-bc33-40cd-a282-a4fe5aa3f0ad2025-10-06WarningsExact identifier
unii: ETJ7Z6XBU4
unii: XF417D3PSL
OneSsip Diphenhydramine HCl 12.5 mg/ 5 mL Oral SolutionDIPHENHYDRAMINE HCLMEDWISE LIFESCIENCES INC.407b7cbb-7ebd-7b7e-e063-6394a90af5012025-10-06WarningsExact identifier
application number: M012
unii: TC2D6JAD40
Quality Choice Medicated Chest RubCAMPHOR, MENTHOL, EUCALYPTUS OILQuality Choice (CHAIN DRUG MARKETING ASSOCIATION)d0cce0a0-a6bc-4c45-b9c6-08865b61c1dc2025-10-06WarningsExact identifier
application number: M012

Reported adverse events (FAERS/openFDA)#

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