FDA.reportPublic FDA data

NDC 50580-286 - Extra Strength TYLENOL Cold plus Flu Multi-Action Day/Night

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
50580-286
Manufacturer
Kenvue Brands LLC
Effective date
2024-11-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Extra Strength TYLENOL Cold plus Flu Multi-Action Day/Night - Kenvue Brands LLCKenvue Brands LLC2024-11-08HUMAN OTC DRUG LABEL

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 202 of 390 · 7,789 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Halls Sugar Free Honey LemonMENTHOLMondelez Global LLC2b19fdd2-8088-47f2-be20-f220a6b825fc2025-10-06WarningsExact identifier
application number: M012
Giltuss Childrens Cough and Chest CongestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINDextrum Laboratories, Inc40802fb6-c1ec-d7b0-e063-6394a90ab4232025-10-06WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
Giltuss DiabeticDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINDextrum Laboratories, Inc3f64c81a-bbfc-4575-e063-6294a90a6ed72025-10-06WarningsExact identifier
application number: M012
TexaClear Severe Cough, Cold and FluCHOLINE SALICYLATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINGM Pharmaceuticals, INCcb99e5b3-1908-43c9-b31f-d35e7ce58b442025-10-06WarningsExact identifier
application number: M012
unii: 9D2RTI9KYH
Vertra Mick Fanning Signature Foundation Sunscreen Face Stick SPF 35 Coolangatta BeigeTITANIUM DIOXIDEToshiki Pigment Co., Ltd.b9eba15f-493a-43c9-e053-2995a90a04512025-10-06WarningsExact identifier
unii: 15FIX9V2JP
SinuLiefLORATADINERoseWell Pharmaceuticals LLC32619143-a782-3497-e063-6394a90aaaec2025-10-06WarningsExact identifier
application number: M012
Acetaminophen, Aspirin and CaffeineACETAMINOPHEN, ASPIRIN AND CAFFEINERising Pharma Holdings, Inc.50f72713-50f5-4bab-9e96-b9fa73c9df1f2025-10-06WarningsExact identifier
unii: 362O9ITL9D
Care One arthritis pain reliefACETAMINOPHENAmerican Sales Companyc5865a69-4fe4-4f0d-9e03-5927dd7374452025-10-06WarningsExact identifier
unii: 362O9ITL9D
OneSsip Acetaminophen Oral Suspension Bubble Gum 5 mLACETAMINOPHEN 160 MG / 5 MLMEDWISE LIFESCIENCES INC.40507559-aee4-a603-e063-6394a90afc4f2025-10-04WarningsExact identifier
unii: 362O9ITL9D
PURE SOL SPF 37 Tinted MoisturizerZINC OXIDE TITANIUM DIOXIDEBrand 2022b LLC4052c4e4-2105-80c0-e063-6294a90af41d2025-10-04WarningsExact identifier
unii: 15FIX9V2JP
STAHIST ADCHLORCYCLIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEMagna Pharmaceuticals, Inc.ccedbc38-2479-4c35-9f86-a9f29bcfab3f2025-10-03WarningsExact identifier
application number: M012
unii: 6V9V2RYJ8N
Advil Multi-Symptom Cold and FluCHLORPHENIRAMINE MALEATE, IBUPROFEN, PHENYLEPHRINE HCLHaleon US Holdings LLC7671d104-3c5c-4f63-b6b1-6c91c22592f82025-10-03WarningsExact identifier
unii: V1Q0O9OJ9Z
AcetaminophenACETAMINOPHENNuCare Pharmaceuticals,Inc.004c39cd-b4f4-1cae-e063-6394a90a06972025-10-03WarningsExact identifier
unii: 362O9ITL9D
Childrens PediaClear 8PYRILAMINE MALEATEGM Pharmaceuticals, INC8e524967-d01c-4c93-9198-c42f15fe3fe02025-10-03WarningsExact identifier
application number: M012
Childrens PediaClear PDTRIPROLIDINE HYDROCHLORIDEGM Pharmaceuticals, INCf3ede5b7-1b0f-493a-b647-4459affc7e542025-10-03WarningsExact identifier
application number: M012
Mucus DGUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDEL. Perrigo Company86993cd9-5d55-4a70-8a33-701d914822922025-10-03WarningsExact identifier
unii: 6V9V2RYJ8N
sinus 12 hourPSEUDOEPHEDRINE HCLL. Perrigo Company26206f75-648f-47c9-8bad-25127c33961d2025-10-03WarningsExact identifier
unii: 6V9V2RYJ8N
Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE AND ACETAMINOPHENEywa Pharma Incfcd2b59e-8087-475e-9e6b-911bd846ea962025-10-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
mucus DGUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDEL. Perrigo Companydb6ada8a-1799-4d35-8bda-4a322fbd7a062025-10-03WarningsExact identifier
unii: 6V9V2RYJ8N
Pain RelieverACETAMINOPHENFamily Dollar (FAMILY WELLNESS)43573e35-6776-446e-aa28-75c8edc5b98d2025-10-03WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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