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 3 of 290 · 5,799 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Maximum Strength Nighttime Cold and FluACETAMINOPHEN , DIPHENHYDRAMINE HCL,PHENYLEPHRINE HCLTHE KROGER CO058b2021-8a61-40b0-8a2e-a784d2b847fb2026-09-02WarningsExact identifier
unii: 362O9ITL9D
Daytime Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, GUAIFENESIN PHENYLEPHRINE HCLThe Kroger Co.494e69ef-dc9f-4e14-b856-5eaf0f541a032026-09-02WarningsExact identifier
unii: 362O9ITL9D
Adult Low Dose Chewable AspirinASPIRINFarmacias De Similares TX LLC513ea306-74c6-96e3-e063-6394a90a82622026-09-01WarningsExact identifier
application number: M013
Kroger Children Pain plus Fever chewablesACETAMINOPHENKROGER COMPANY83b5733c-70a1-4383-9729-2eb896d0149a2026-09-01WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLTOP CARE (Topco Associates LLC)923b443d-73cc-4c52-92e4-a075786b1ae32026-09-01WarningsExact identifier
application number: M013
unii: 362O9ITL9D
ACETAMINOPHEN PMACETAMINOPHEN, DIPHENHYDRAMINE HCLAmazon.com Services LLC99a137d6-07eb-43bc-b4b4-1a23041d595e2026-08-31WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Acetaminophen Extra StrengthACETAMINOPHENCVS PHARMACY64a1ebe7-af28-4b09-96e8-28fa4dcc52bd2026-08-31WarningsExact identifier
application number: M013
rxcui: 198440
unii: 362O9ITL9D
Daytime Cold and Flu Multi Symptom ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLShield Pharmaceuticals Corpe85b4c2a-d4e0-452c-9a08-fcc0ff6eaa212026-08-31WarningsExact identifier
unii: 362O9ITL9D
MAX relief junior GrapeCHILDRENS ACETAMINOPHENAkron Pharma Inc.cc769c26-556a-4831-bd75-61a7383aa7072026-08-31WarningsExact identifier
application number: M013
unii: 362O9ITL9D
MAX relief juniorCHILDRENS ACETAMINOPHENAkron Pharma Inc.ebb3b4ba-2d0b-48d9-b6ee-6d4696aea0472026-08-31WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Daytime Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLShield Pharmaceuticals Corp67849e09-2056-4013-98b1-d003ed3250a22026-08-31WarningsExact identifier
unii: 362O9ITL9D
MAX relief juniorACETAMINOPHENAkron Pharma Inc.0e43b885-3843-4f11-9a53-02a38c2283132026-08-31WarningsExact identifier
application number: M013
unii: 362O9ITL9D
MAX relief juniorCHILDREN ACETAMINOPHENAkron Pharma Inc.d7874e4d-0b38-4bb1-9a62-aa4f66d9baf92026-08-31WarningsExact identifier
application number: M013
unii: 362O9ITL9D
MAX relief junior GrapeCHILDREN ACETAMINOPHENAkron Pharma Inc.3c7a7f40-4963-4fd1-942e-93fa08a458302026-08-31WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Genexa Kids Pain and FeverACETAMINOPHENGenexa Inc.5a615118-33c9-1520-e063-6394a90a21a62026-08-31WarningsExact identifier
application number: M013
unii: 362O9ITL9D
Acetaminophen PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLUnited Natural Foods, Inc. dba UNFI24173e77-92ec-4a87-a471-d6867837c1802026-08-31WarningsExact identifier
unii: 362O9ITL9D
acetaminophen extra strengthACETAMINOPHENSam's West Incdd99efd0-4ca4-4dc6-a940-bebd17ac8f8d2026-08-28WarningsExact identifier
application number: M013
rxcui: 198440
unii: 362O9ITL9D
Aspirin 81 mgASPIRINHAWAII REPACK, INC.ac94cce3-9a39-41de-bb8b-10a5e5b8e83b2026-08-28WarningsExact identifier
application number: M013
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
AcetaminophenACETAMINOPHENREMEDYREPACK INC.464e404a-1957-44a2-a53a-f2a9d3c15bde2026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 362O9ITL9D

Reported adverse events (FAERS/openFDA)#

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