FDA.reportPublic FDA data

TYLENOL

Product NDC
50580-600
Requested package NDC
50580-600-02
11-digit product format
505800600
Labeler code
50580
Product ID
50580-600_e292b578-1351-d97e-e053-2a95a90aa29b
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2017-05-31
Marketing end
0000-00-00
Substance
ACETAMINOPHEN
Active strength
325 mg/1
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 packagepackage50580-60050580-600-02DDiscontinued by firm2026-10-05

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.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50580-600-012025-07-29C16284748780-13b156c62-2af5-fb37-e063-e6dba90a4e07TYLENOL Regular Strength
50580-600-022025-07-29C16284748780-13b156c62-2af5-fb37-e063-e6dba90a4e07TYLENOL Regular Strength
50580-600-032025-07-29C16284748780-13b156c62-2af5-fb37-e063-e6dba90a4e07TYLENOL Regular Strength

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-600-01EA - Each50580-6007c340e86-6387-4291-b519-c581723ba2a812018-02-20
50580-600-02EA - Each50580-600eb77fba1-7c36-4d7e-a5d8-3a10dded598912017-07-07
50580-600-03EA - Each50580-60031f77edc-3bb5-4e99-94f7-767c6a3b821e12018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-600TYLENOL REGULAR STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [KENVUE BRANDS LLC]8Legacy NDC20241109_511536b2-6cbd-463e-b2db-6feec474cf6b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50580-600-025058006000210 BLISTER PACK in 1 CARTON (50580-600-02) > 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2017-05-310000-00-00NoNoCurrent