FDA.reportPublic FDA data

TYLENOL

Product NDC
50580-600
Requested package NDC
50580-600-03
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 packagepackage50580-60050580-600-03DDiscontinued 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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50580-60050580-600-03IInactivated by FDAexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50580-60050580-600-03IInactivated by FDAexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50580-600-03505800600031000 TABLET, FILM COATED in 1 BOTTLE (50580-600-03) 2017-08-310000-00-00NoNoCurrent