NDC 50580-488-15 - TYLENOL Extra Strength

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
50580-488
Requested NDC
50580-488-15
Package NDCs from labels
50580-488-10, 50580-488-24, 50580-488-25, 50580-488-28, 50580-488-01, 50580-488-52, 50580-488-02, 50580-488-50, 50580-488-22, 50580-488-15
Manufacturer
Kenvue Brands LLC
Effective date
2026-04-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
TYLENOL Extra Strength - Kenvue Brands LLCKenvue Brands LLC2026-04-07HUMAN OTC DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-488-01TYLENOLExtra Strength2 in 1 POUCHTABLET, COATED218
50580-488-01TYLENOLExtra Strength50 in 1 TRAYTABLET, COATED5018
50580-488-02TYLENOLExtra Strength2 in 1 POUCHTABLET, COATED218
50580-488-02TYLENOLExtra Strength5 in 1 CARTONTABLET, COATED518
50580-488-10TYLENOLExtra Strength100 in 1 BOTTLE, PLASTICTABLET, COATED10018
50580-488-10TYLENOLExtra Strength1 in 1 CARTONTABLET, COATED118
50580-488-22TYLENOLExtra Strength200 in 1 BOTTLETABLET, COATED20018
50580-488-22TYLENOLExtra Strength1 in 1 CARTONTABLET, COATED118
50580-488-24TYLENOLExtra Strength1 in 1 CARTONTABLET, COATED118
50580-488-24TYLENOLExtra Strength24 in 1 BOTTLE, PLASTICTABLET, COATED2418
50580-488-25TYLENOLExtra Strength225 in 1 BOTTLE, PLASTICTABLET, COATED22518
50580-488-25TYLENOLExtra Strength1 in 1 CARTONTABLET, COATED118
50580-488-28TYLENOLExtra Strength290 in 1 BOTTLE, PLASTICTABLET, COATED29018
50580-488-50TYLENOLExtra Strength2500 in 1 CARTONTABLET, COATED250018
50580-488-50TYLENOLExtra Strength2 in 1 POUCHTABLET, COATED218
50580-488-52TYLENOLExtra Strength50 in 1 BOTTLE, PLASTICTABLET, COATED5018
50580-488-52TYLENOLExtra Strength1 in 1 CARTONTABLET, COATED118

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-488TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [KENVUE BRANDS LLC]16Current NDC, Legacy NDC, 17 package rows20241109_1b164780-ec84-4187-8afa-6f8a0da550fc.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-488-10EA - Each50580-48843c31ddd-e3ca-43ce-ae33-a674d10bbe0c12012-07-24
50580-488-15EA - Each50580-488fc3c107f-685f-4435-81e5-dd7ea181f7cd12012-07-24
50580-488-24EA - Each50580-48886fba9c5-181e-44b9-987b-7865e8fd76de12012-07-24
50580-488-25EA - Each50580-488d5950c89-46b5-4a11-a65c-0dbc56cedda612018-03-08
50580-488-50EA - Each50580-488350a7da3-5b4e-4e16-8573-c223b2c25fc112012-07-24
50580-488-52EA - Each50580-4883f9ca0e5-9485-4ff3-a5ca-da2a9ecbccb512024-04-05

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 2 of 290 · 5,799 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cold and Flu HBPACETAMINOPHEN, CHLORPHENIRAMINE MALEATEWALMART INC.f9d1dfd1-527f-491d-9188-14886ac70ced2026-09-08WarningsExact identifier
unii: 362O9ITL9D
Pain Relief Extra StrengthACETAMINOPHENRite Aid Corporationd846065a-5c39-4f4b-894c-4280acaaf4fa2026-09-08WarningsExact identifier
application number: M013
rxcui: 198440
unii: 362O9ITL9D
severe cold and cough daytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDERARITAN PHARMACEUTICALS INC3ce8508e-7d9d-4413-858a-8f952e760c012026-09-08WarningsExact identifier
unii: 362O9ITL9D
Multi Symptom Severe ColdACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLRARITAN PHARMACEUTICALS INCd9606c9a-31b1-4121-9870-809a05f5b68a2026-09-08WarningsExact identifier
unii: 362O9ITL9D
DESENFRIOL-ITO PLUSACETAMINOPHENOPMX LLC5ac41edd-e845-734d-e063-6294a90a990a2026-09-05WarningsExact identifier
application number: M013
unii: 362O9ITL9D
DRX CHOICE Regular StrengthACETAMINOPHENRaritan Pharmaceuticals Inc.8bacb24a-24d0-4175-b3e0-05efb5f5d3732026-09-05WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.49235f4f-e661-4a83-88ef-b9a9568487772026-09-04WarningsExact identifier
unii: 362O9ITL9D
NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEAmazon.com Services LLC774d2bde-9f57-4ced-800a-cada39c685ed2026-09-04WarningsExact identifier
unii: 362O9ITL9D
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Butalbital, Acetaminophen, CaffeineBUTALBITAL, ACETAMINOPHEN, AND CAFFEINEREMEDYREPACK INC.dc2bb7fc-1722-4865-a02c-be5e5c2115052026-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D
Feverall Jr. StrengthACETAMINOPHENSun Pharmaceutical Industries, Inc.3561bbc3-53b0-4857-8b71-39e165ed95ce2026-09-03WarningsExact identifier
unii: 362O9ITL9D
infants pain and feverACETAMINOPHENCVS Pharmacy53b06c48-598e-41ad-ac7a-5508c195535c2026-09-03WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Aspirin Regular StrengthASPIRINCardinal Health 110, LLC. DBA Leader2777beea-06d7-4ff5-ae4a-ad7a117dfb622026-09-02WarningsExact identifier
application number: M013
AMAZON BASIC CARE ACETAMINOPHENACETAMINOPHENAmazon.com Services LLC113d92bf-f6c9-cc3d-e063-6294a90af0332026-09-02WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Childrens Multi Symptom Fever and ColdACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLTHE KROGER CO.3daf7620-eb57-43d5-ba88-938b7221e3462026-09-02WarningsExact identifier
unii: 362O9ITL9D
Extra Strength Pain RelieverACETAMINOPHENShield Pharmaceuticals Corp.78052120-40d8-4a3f-b72f-cc78ca76213b2026-09-02WarningsExact identifier
application number: M013
rxcui: 198440
unii: 362O9ITL9D
Nighttime Cold and Flu Multi Symptom ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEShield Pharmaceuticals Corpdecafa3a-3734-4161-bab0-1219458818462026-09-02WarningsExact identifier
unii: 362O9ITL9D
Nighttime Severe Cold and CoughACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINEKROGER COMPANY7def6781-0881-46bf-ad7a-7a3f23a8d9f72026-09-02WarningsExact identifier
unii: 362O9ITL9D
Maximum Strength Cold Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLKROGER COMPANYe1d27123-358f-4b0c-8e3b-33474750a0e62026-09-02WarningsExact identifier
unii: 362O9ITL9D
Kroger Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEKroger Companyc5ce0901-a5d7-46c4-8492-5a80c76e85172026-09-02WarningsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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