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 193 of 335 · 6,691 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nighttime Cough DMDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEL.N.K. International, Inc.75a9c736-bc7e-4b7f-84ea-9474a37508ec2025-06-10WarningsExact identifier
application number: M012
DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESINDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINKJD Pharma Private Limited8877bb8d-479f-4968-8033-5c269d449a462025-06-10WarningsExact identifier
application number: M012
BenadrylDIPHENHYDRAMINE HYDROCHLORIDEMorning Star OTCf4ff84b3-bb0c-4900-8ba4-6d1b903947822025-06-09WarningsExact identifier
application number: M012
unii: TC2D6JAD40
Equate Kids Daytime Dex Cough GelsDEXTROMETHORPHANWalmart37269cd6-1528-9879-e063-6394a90a2b542025-06-09WarningsExact identifier
application number: M012
Children Acetaminophen Oral SolutionACETAMINOPHENMAJOR PHARMACEUTICALScfca5147-f390-40bd-8f13-c5b3b8d1c5b02025-06-09WarningsExact identifier
unii: 362O9ITL9D
Nuvicare DayTime Cold and Flu SoftgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDENUVICARE LLCbdc35570-c8df-4797-a13e-7f2479ec42b72025-06-09WarningsExact identifier
application number: M012
unii: 362O9ITL9D
Nuvicare DayTime and NightTime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATENUVICARE LLCf5764925-c586-40e4-8252-24d92389af012025-06-09WarningsExact identifier
application number: M012
Nuvicare NightTime Cold and Flu SoftgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATENUVICARE LLC2a29f0ed-d86b-4787-84e0-f7a8c5e7581f2025-06-09WarningsExact identifier
application number: M012
unii: 362O9ITL9D
Nuvicare DayTime and NightTime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATENUVICARE LLC7fa8e4ad-95cb-4905-90db-d53b3bc87c412025-06-09WarningsExact identifier
application number: M012
Childrens Pain and FeverACETAMINOPHENCVS Pharmacyd6c8118c-bf78-4194-9b14-8de33c3ecdb72025-06-06WarningsExact identifier
unii: 362O9ITL9D
HAIR STIMPEDICULUS CAPITIS, THYROIDINUM (SUIS), BARYTA CARBONICA, BORAX, CALCAREA CARBONICA, CINCHONA OFFICINALIS, GLANDULA SUPRARENALIS SUIS, HYDROFLUORICUM ACIDUM, MERCURIUS SOLUBILIS, MEZEREUM, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SEPIA, SILICEA, SULPHUR, THUJA OCCIDENTALIS, VINCA MINORThe Wellness Center for Research and Education, Inc.8ecc05ff-ed5a-4157-9100-1c7912686f072025-06-06WarningsExact identifier
unii: ETJ7Z6XBU4
fever reducing childrensACETAMINOPHENCVS Pharmacy9d89544f-3a66-4f23-b609-381d027e0c952025-06-06WarningsExact identifier
unii: 362O9ITL9D
SLIMLYCOPODIUM CLAVATUM, ABIES CANADENSIS, AMMONIUM BROMATUM, AMMONIUM MURIATICUM, PHYTOLACCA DECANDRA, PULSATILLA (PRATENSIS), AMMONIUM CARBONICUM, FUCUS VESICULOSUS, CAPSICUM ANNUUM, ARGENTUM NITRICUM, KALI BICHROMICUM, SILICEA, GLANDULA SUPRARENALIS BOVINE, CALCAREA ARSENICICA, FERRUM METALLICUM, ANTIMONIUM CRUDUM, CALCAREA CARBONICA, GRAPHITES, KALI CARBONICUM, ANACARDIUM ORIENTALE, IODIUM, THYROIDINUM (SUIS), LEPTINThe Wellness Center for Research and Education5067953f-351e-4bb0-b165-8dc62077cdea2025-06-06WarningsExact identifier
unii: ETJ7Z6XBU4
Bio ElectrolyteBORON CITRATE, CALCIUM GLUCONATE, CHROMIUM PICOLINATE, COBALT GLUCONATE, COPPER GLUCONATE, MAGNESIUM GLUCONICUM DIHYDRICUM, MANGANESE GLUCONATE, NICKEL ACETATE, POTASSIUM GLUCONATE, SELENIUM DIOXIDE, SODIUM GLUCONATE, ZINCUM GLUCONICUM, FERRUM SULPHURICUM, KALI PHOSPHORICUM, VANADIUM METALLICUM, CALCAREA PHOSPHORICABioActive Nutritional, Inc.4482b868-4274-4fe7-8f5c-cf4eca3ecab82025-06-06WarningsExact identifier
unii: 91D9GV0Z28
BioTox Dental Foci RepairARNICA MONTANA, HYPERICUM PERFORATUM, PLANTAGO MAJOR, ACONITUM NAPELLUS, MERCURIUS SOLUBILIS, HEKLA LAVA, ARGENTUM NITRICUM, BELLADONNA, HEPAR SULPHURIS CALCAREUM, SILICEAThe Wellness Center For Research and Education767f8dd2-759f-4662-9b5c-b8832309363d2025-06-06WarningsExact identifier
unii: ETJ7Z6XBU4
Silicea 6XSILICEA 6XTrue Botanica, LLC2cee8f0b-6d28-75e4-e063-6294a90a2e152025-06-05WarningsExact identifier
unii: ETJ7Z6XBU4
Vaporizing Steam LiquidMEDICATED COUGH SUPPRESSANTNeilMed Pharmaceuticals Inc.36cf6218-adb8-9d8b-e063-6394a90a49a02025-06-05WarningsExact identifier
application number: M012
Geri-Tussin DMDEXTROMETHORPHAN HBR, GUAIFENESINGeri-Care Pharmaceuticals, Corp7e2fb43c-a7f1-4c1d-a700-7c6510999c032025-06-05WarningsExact identifier
application number: M012
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEDIRECT RXa8206207-ad09-83df-e053-2995a90a78b72025-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Pharbetol Regular strengthACETAMINOPHENATLANTIC BIOLOGICALS CORP.05a91d24-b498-4ba2-a275-68b871cf62d22025-06-05WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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