FDA.reportPublic FDA data

TYLENOL Extra Strength

Product NDC
50580-457
11-digit product format
505800457
Labeler code
50580
Product ID
50580-457_2ddb1260-fde6-1914-e063-6394a90a82d7
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Kenvue Brands LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-07-10
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
TYLENOL Extra Strength
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198440Internal RxNorm lookup
209459Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c830320e-72ba-48ff-a4cd-250ac5650bf0Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-457-10TYLENOL Extra Strength100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1009
50580-457-10TYLENOL Extra Strength1 in 1 CARTONTABLET, FILM COATED19
50580-457-11TYLENOL Extra Strength10 in 1 BLISTER PACKTABLET, FILM COATED109
50580-457-11TYLENOL Extra Strength10 in 1 CARTONTABLET, FILM COATED109
50580-457-70TYLENOL Extra Strength700 in 1 BOTTLE, PLASTICTABLET, FILM COATED7009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-457-11EA - Each50580-457c86e83a8-18ef-42d7-80bf-c165e09112fd12021-02-05
50580-457-70EA - Each50580-4575487d689-2225-4f7d-a25b-71326b8c986b12021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-457TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [KENVUE BRANDS LLC]9Current NDC, Legacy NDC, 5 package rows20250221_c830320e-72ba-48ff-a4cd-250ac5650bf0.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 57 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
foster and thrive pain relieverACETAMINOPHENStrategic Sourcing Services LLC338021bd-b92b-45eb-a4b8-bc4a100ab7182024-11-06WarningsExact identifier
application number: M013
basic care headache reliefACETAMINOPHEN, ASPIRIN, CAFFEINEAmazon.com Services LLCf85d2f4c-8184-4555-a310-3979722e860b2024-11-05WarningsExact identifier
application number: M013
MENSTRUAL COMPLETEMENSTRUAL COMPLETEAllegiant Healthd197b886-67e4-4aba-8582-305576c076042024-11-05WarningsExact identifier
application number: M013
dg health headache reliefACETAMINOPHEN, ASPIRIN, CAFFEINEDolgencorp Incddf40cc4-d73f-4460-be72-9486134329a72024-11-05WarningsExact identifier
application number: M013
DOLO- NeuroBion Acetaminophen 500mgACETAMINOPHENBENARD INDUSTRIES INC16f8415d-8190-4212-b487-c0caf7d3bee22024-11-04WarningsExact identifier
application number: M013
basic care acetaminophenACETAMINOPHENAmazon.com Services LLC8c3343ee-d7b6-496d-9702-6736539a72702024-11-02WarningsExact identifier
application number: M013
dg health pain reliefACETAMINOPHENDolgencorp, LLC382fa2cc-1c39-4bee-b528-08b11ec945af2024-11-02WarningsExact identifier
application number: M013
acetaminophenACETAMINOPHENBryant Ranch Prepackf7e20527-1d4b-434c-997b-3eb8211fdaa12024-11-01WarningsExact identifier
application number: M013
Aspirin Enteric Safety CoatedASPIRINPublix Supermarkets, Inc.a661a9ed-9b31-46b1-aafb-61d1ba8a49182024-11-01WarningsExact identifier
application number: M013
acetaminophenACETAMINOPHENBryant Ranch Prepack614e69c7-d3cb-4d47-9603-c1c14b87544c2024-11-01WarningsExact identifier
application number: M013
infants fever reducer and pain relieverACETAMINOPHENRite Aid Corporationbaee03b8-fcfd-440e-90ea-1ee2a18516ef2024-11-01WarningsExact identifier
application number: M013
good neighbor pharmacy infants pain and feverACETAMINOPHENAmerisource Bergenbfb954b7-3a79-4bca-95e8-d39e1074b07f2024-11-01WarningsExact identifier
application number: M013
EXTRA STRENGTH PAIN RELIEVERACETAMINOPHEN, ASPIRIN AND CAFFEINEProficient Rx LPbf365bfc-35cc-47f9-a50b-ff2b38d7316b2024-11-01WarningsExact identifier
application number: M013
Infants Pain ReliefACETAMINOPHENPublix Super Markets Inc0bc33897-afc2-4d11-be6c-a26480f448bf2024-10-31WarningsExact identifier
application number: M013
equate infants pain and feverACETAMINOPHENWALMART INC.34b2512e-743b-45db-92cb-ea05e2f47b3d2024-10-31WarningsExact identifier
application number: M013
foster and thrive infants pain and feverACETAMINOPHENStrategic Sourcing Services LLC45770ad6-9bf7-41bd-a724-e5260cd31fa12024-10-31WarningsExact identifier
application number: M013
Midol CompleteACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE TABLETLil' Drug Store Products, Inc.d20425a4-f074-4154-e053-2995a90ae9fd2024-10-30WarningsExact identifier
application number: M013
up and up infants acetaminophenACETAMINOPHENTarget Corporation31104956-04d7-41b5-82be-219ded5c02a92024-10-30WarningsExact identifier
application number: M013
Sunmark AspirinASPIRINStrategic Sourcing Services LLCa7139686-b351-47dc-a395-832429aaa5692024-10-30WarningsExact identifier
application number: M013
Good Neighbor Pharmacy Pain ReliefACETAMINOPHENAmerisource Bergen5101125d-4819-4e4b-a0ee-a0ff8d5a0ab12024-10-30WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNc830320e-72ba-48ff-a4cd-250ac5650bf09
209459Tylenol Extra Strength 500 MG Oral TabletPSNc830320e-72ba-48ff-a4cd-250ac5650bf09
209459acetaminophen 500 MG Oral Tablet [Tylenol]SBDc830320e-72ba-48ff-a4cd-250ac5650bf09
198440acetaminophen 500 MG Oral TabletSCDc830320e-72ba-48ff-a4cd-250ac5650bf09
198440APAP 500 MG Oral TabletSYc830320e-72ba-48ff-a4cd-250ac5650bf09
209459APAP 500 MG Oral Tablet [Tylenol]SYc830320e-72ba-48ff-a4cd-250ac5650bf09
209459Tylenol 500 MG Oral TabletSYc830320e-72ba-48ff-a4cd-250ac5650bf09
209459Tylenol Extra Strength 500 MG Oral TabletSYc830320e-72ba-48ff-a4cd-250ac5650bf09

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50580-457-10505800457101 BOTTLE, PLASTIC in 1 CARTON (50580-457-10) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2020-07-100000-00-00NoNoCurrent
50580-457-115058004571110 BLISTER PACK in 1 CARTON (50580-457-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2020-07-170000-00-00NoNoCurrent
50580-457-7050580045770700 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50580-457-70) 2020-07-170000-00-00NoNoCurrent