FDA.reportPublic FDA data

TYLENOL

Product NDC
50580-488
11-digit product format
505800488
Labeler code
50580
Product ID
50580-488_4eda2608-4d48-1af0-e063-6294a90a2c72
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Kenvue Brands LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-01-16
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50580-48850580-488-01DDiscontinued by firm2026-10-15

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
2027-12-31

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
1b164780-ec84-4187-8afa-6f8a0da550fcAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
377068df-225f-7318-a910-a1987cdfa361Product name320170608
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

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 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

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

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 27 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acetaminophen Diphenhydramine HCLACETAMINOPHEN DIPHENHYDRAMINE HCLWALGREENS CO.d92d97a8-0ee3-1206-e053-2a95a90a72a82025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENSAM'S WEST INC0c8e7095-0806-4501-e063-6394a90a89aa2025-12-19WarningsExact identifier
application number: M013
Acetaminophen Diphenhydramine HCLACETAMINOPHEN DIPHENHYDRAMINE HCLWALGREEN CO.b3763182-2428-155a-e053-2995a90ab5782025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENWALGREENSe467b78e-9f23-5563-e053-2a95a90a586e2025-12-19WarningsExact identifier
application number: M013
Acetaminophen Diphenhydramine HCLACETAMINOPHEN DIPHENHYDRAMINE HCLWalgreensfd7c3250-35d4-494a-e053-6394a90a2db52025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCVS PHARMACY, INC1ddb8a2b-3081-3eda-e063-6294a90ab82b2025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCVS PHARMACY, INCb1307d52-10e6-46e1-e053-2995a90a03b62025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCVS PHARMACY, INCc2c6d6a1-b492-506d-e053-2995a90aac232025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENFAMILY DOLLARf8383108-0970-9f1e-e053-6294a90ad38f2025-12-19WarningsExact identifier
application number: M013
ACETAMINOPHEN 500 MGACETAMINOPHENNUVICARE LLC591ee107-e953-4982-b75f-13a0afd7c4ae2025-12-19WarningsExact identifier
application number: M013
Nuvicare Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINENUVICARE LLC3ede0fb6-c089-4253-9878-2b01c39e9c872025-12-19WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINNUVICARE LLC3a4aa3c7-b726-4303-8803-74196fa5637a2025-12-19WarningsExact identifier
application number: M013
ACETAMINOPHEN 500 MGACETAMINOPHENNUVICARE LLC95edf7bd-b6a7-4be5-9ad7-8748e7c2d06e2025-12-19WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINENUVICARE LLC32a5611b-9bf6-4850-a7ff-fa240da04f452025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENBETTER LIVING BRANDS LLC.ac0e96d0-746e-fb42-e053-2a95a90a19572025-12-18WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENBETTER LIVING BRANDS LLC.ac0e5dc0-96eb-47b2-e053-2995a90add0e2025-12-18WarningsExact identifier
application number: M013
Acetaminophen Diphenhydramine HClACETAMINOPHEN DIPHENHYDRAMINE HCLBETTER LIVING BRANDS LLC.ac0f8d5c-d200-1156-e053-2a95a90aece62025-12-18WarningsExact identifier
application number: M013
Pain and Fever ChildrensACETAMINOPHENCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDe55645ab-66f9-4160-8247-395bc5b027112025-12-18WarningsExact identifier
application number: M013
Dolex ForteACETAMINOPHEN, ASPIRIN, CAFFEINEPharmadel LLC3c2d90fc-130d-476c-e063-6294a90a8c152025-12-17WarningsExact identifier
application number: M013
CareOne Childrens AcetaminophenACETAMINOPHENAmerican Sales Company07bc6632-fabb-427d-81f3-c27c54caa6a02025-12-17WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSN1b164780-ec84-4187-8afa-6f8a0da550fc18
209459Tylenol Extra Strength 500 MG Oral TabletPSN1b164780-ec84-4187-8afa-6f8a0da550fc18
209459acetaminophen 500 MG Oral Tablet [Tylenol]SBD1b164780-ec84-4187-8afa-6f8a0da550fc18
198440acetaminophen 500 MG Oral TabletSCD1b164780-ec84-4187-8afa-6f8a0da550fc18
198440APAP 500 MG Oral TabletSY1b164780-ec84-4187-8afa-6f8a0da550fc18
209459APAP 500 MG Oral Tablet [Tylenol]SY1b164780-ec84-4187-8afa-6f8a0da550fc18
209459Tylenol 500 MG Oral TabletSY1b164780-ec84-4187-8afa-6f8a0da550fc18
209459Tylenol Extra Strength 500 MG Oral TabletSY1b164780-ec84-4187-8afa-6f8a0da550fc18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50580-488-01505800488012 in 1 POUCHHistorical
50580-488-02505800488025 POUCH in 1 CARTON (50580-488-02) / 2 TABLET, COATED in 1 POUCH5 pouch2026-01-15NoNoCurrent
50580-488-10505800488101 BOTTLE, PLASTIC in 1 CARTON (50580-488-10) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC2017-01-160000-00-00NoNoCurrent
50580-488-22505800488221 BOTTLE in 1 CARTON (50580-488-22) / 200 TABLET, COATED in 1 BOTTLE1 bottle2026-06-01NoNoCurrent
50580-488-24505800488241 BOTTLE, PLASTIC in 1 CARTON (50580-488-24) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC2017-01-160000-00-00NoNoCurrent
50580-488-25505800488251 BOTTLE, PLASTIC in 1 CARTON (50580-488-25) / 225 TABLET, COATED in 1 BOTTLE, PLASTIC2017-01-160000-00-00NoNoCurrent
50580-488-2850580048828290 TABLET, COATED in 1 BOTTLE, PLASTIC (50580-488-28) 2017-01-160000-00-00NoNoCurrent
50580-488-50505800488502500 POUCH in 1 CARTON (50580-488-50) / 2 TABLET, COATED in 1 POUCH2500 pouch2026-01-15NoNoCurrent
50580-488-52505800488521 BOTTLE, PLASTIC in 1 CARTON (50580-488-52) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC2019-06-170000-00-00NoNoCurrent