FDA.reportPublic FDA data

TYLENOL

Product NDC
50580-692
11-digit product format
505800692
Labeler code
50580
Product ID
50580-692_21c193b9-6b79-f35c-e063-6394a90adbfe
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
2018-08-06
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
Brand name suffix
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
dd87e342-b0cb-4111-9f15-415dbcda4b77Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-692-01TYLENOLExtra Strength1 in 1 CARTONTABLET, FILM COATED17
50580-692-01TYLENOLExtra Strength24 in 1 BOTTLETABLET, FILM COATED247
50580-692-02TYLENOLExtra Strength1 in 1 CARTONTABLET, FILM COATED17
50580-692-02TYLENOLExtra Strength100 in 1 BOTTLETABLET, FILM COATED1007
50580-692-03TYLENOLExtra Strength225 in 1 BOTTLETABLET, FILM COATED2257
50580-692-03TYLENOLExtra Strength1 in 1 CARTONTABLET, FILM COATED17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-692-02EA - Each50580-69260ad3bb5-7156-473b-b710-4e1ac1510e6112024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-692TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [KENVUE BRANDS LLC]7Current NDC, Legacy NDC, 6 package rows20241109_dd87e342-b0cb-4111-9f15-415dbcda4b77.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 45 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain ReliefACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION, INC.1c083e29-8732-4ecd-ab4b-9038acbd0b9d2025-05-22WarningsExact identifier
application number: M013
TYLENOL For Children Plus AdultsACETAMINOPHENKenvue Brands LLC5bb8ef99-a94b-49f9-89f9-cd1ce0a47a422025-05-21WarningsExact identifier
application number: M013
Children AcetaminophenACETAMINOPHENAARNA USA INC.25bcb9d5-f388-4ae7-8037-970ffe8d17f02025-05-16WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENHF Acquisition Co LLC, DBA HealthFirst35478de8-50d0-5d0a-e063-6294a90a88ba2025-05-16WarningsExact identifier
application number: M013
Extra Strength AcetaminophenACETAMINOPHENPreferred Pharmaceuticals Inc.95f4b628-6d35-4f6b-91f9-b2d117f8e8212025-05-16WarningsExact identifier
application number: M013
good neighbor pharmacy childrens pain and feverACETAMINOPHENAmerisource Bergen268a789b-8f31-4739-9777-523249cac3262025-05-13WarningsExact identifier
application number: M013
ASPIRIN LOW DOSEASPIRIN LOW DOSEAARNA USA INC.347edc8f-6391-b75e-e063-6394a90a1cf52025-05-06WarningsExact identifier
application number: M013
Good Neighbor Pharmacy Infants Pain and FeverACETAMINOPHENAmerisource Bergen2cfbb8ad-3ecb-432b-9eb4-16c51bf23bb22025-05-06WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENAARNA USA INC.34157f6a-3031-4388-e063-6394a90a670f2025-05-01WarningsExact identifier
application number: M013
ASPIRINASPIRINHF Acquisition Co LLC, DBA HealthFirst2553d0cb-3f5c-7ea0-e063-6294a90a3cd42025-05-01Warnings, Adverse reactionsExact identifier
application number: M013
Aspirin 81mg Enteric CoatedASPIRINAdvanced Rx LLC606067bb-b07f-444e-9465-d1e187735f3a2025-05-01WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENAARNA USA INC.33f0e822-28af-9bb2-e063-6294a90a51752025-04-29WarningsExact identifier
application number: M013
Extra Strength AcetaminophenACETAMINOPHENGeri-Care Pharmaceutical Corp27fcca07-f845-77fe-e063-6394a90aa2f82025-04-24WarningsExact identifier
application number: M013
acetaminophenACETAMINOPHENA-S Medication Solutions46a6bbb9-ccd1-47a8-9e58-485f71f570632025-04-24WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENA-S Medication Solutions061c91d5-5aa8-4556-a344-197b7e8a10b82025-04-24WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENA-S Medication Solutionsc4f0f591-8501-4c6d-bf8e-ca3068ff65b52025-04-24WarningsExact identifier
application number: M013
Extra Strength No-PainACETAMINOPHENSafrel Pharmaceuticals, LLC.873f01dd-0701-5fd3-e053-2a95a90a64632025-04-23WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENChain Drug Consortium60d4b392-6ed0-4115-8154-24eaf72504a52025-04-16WarningsExact identifier
application number: M013
Premsyn pms Premenstrual Pain ReliefACETAMINOPHEN AND PAMABROM AND PYRILAMINE MALEATEFocus Consumer Healthcare, LLC5b6f6260-69ae-cfeb-e053-2a91aa0a6b492025-04-14WarningsExact identifier
application number: M013
BackAid MaxACETAMINOPHEN, PAMABROMKobayashi Healthcare International, Inc.fb9a5647-b7c9-4820-b148-91060e34cb832025-04-14WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNdd87e342-b0cb-4111-9f15-415dbcda4b777
209459Tylenol Extra Strength 500 MG Oral TabletPSNdd87e342-b0cb-4111-9f15-415dbcda4b777
209459acetaminophen 500 MG Oral Tablet [Tylenol]SBDdd87e342-b0cb-4111-9f15-415dbcda4b777
198440acetaminophen 500 MG Oral TabletSCDdd87e342-b0cb-4111-9f15-415dbcda4b777
198440APAP 500 MG Oral TabletSYdd87e342-b0cb-4111-9f15-415dbcda4b777
209459APAP 500 MG Oral Tablet [Tylenol]SYdd87e342-b0cb-4111-9f15-415dbcda4b777
209459Tylenol 500 MG Oral TabletSYdd87e342-b0cb-4111-9f15-415dbcda4b777
209459Tylenol Extra Strength 500 MG Oral TabletSYdd87e342-b0cb-4111-9f15-415dbcda4b777

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50580-692-01505800692011 BOTTLE in 1 CARTON (50580-692-01) / 24 TABLET, FILM COATED in 1 BOTTLE1 bottle2018-08-060000-00-00NoNoCurrent
50580-692-02505800692021 BOTTLE in 1 CARTON (50580-692-02) / 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2018-08-060000-00-00NoNoCurrent
50580-692-03505800692031 BOTTLE in 1 CARTON (50580-692-03) / 225 TABLET, FILM COATED in 1 BOTTLE1 bottle2018-08-060000-00-00NoNoCurrent