FDA.reportPublic FDA data

Pharbetol

Product NDC
50090-0395
Requested package NDC
50090-0395-0
11-digit product format
500900395
Labeler code
50090
Product ID
50090-0395_4c82bf4e-7963-4538-ba6b-54368c25d4ea
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2006-01-10
Marketing end
0000-00-00
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
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 packagepackage50090-039550090-0395-0DDiscontinued 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 · 11 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…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50090-0395-02023-02-07Drug Facts
50090-0395-12023-02-07Drug Facts
50090-0395-22023-02-07Drug Facts
50090-0395-32023-02-07Drug Facts
50090-0395-42023-02-07Drug Facts
50090-0395-52023-02-07Drug Facts
50090-0395-82023-02-07Drug Facts
50090-0395-02023-01-30Drug Facts
50090-0395-12023-01-30Drug Facts
50090-0395-22023-01-30Drug Facts
50090-0395-32023-01-30Drug Facts
50090-0395-42023-01-30Drug Facts
50090-0395-52023-01-30Drug Facts
50090-0395-82023-01-30Drug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0395-0EA - Each50090-0395e50bb63c-9567-4d2a-9bc1-9dabb9c40a7412018-09-05
50090-0395-1EA - Each50090-0395a7318c53-2a00-4583-86f3-1a1ed057253812018-09-05
50090-0395-2EA - Each50090-039541d46d62-cd1c-409d-80f1-d8b34232066c12018-09-05
50090-0395-3EA - Each50090-03958efc4c61-188a-4ef3-8970-427d42ae58b812018-09-05
50090-0395-4EA - Each50090-03951918e45a-fbba-461e-b03c-f924436dea4312018-09-05
50090-0395-5EA - Each50090-0395184b46d2-004d-49c8-acd6-1e72725cd87a12018-09-05
50090-0395-8EA - Each50090-0395af310dac-226d-4b35-a2c4-6a3e990d497f12018-09-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0395-05009003950015 TABLET in 1 BOTTLE (50090-0395-0) 15 tablet2014-11-280000-00-00NoNoCurrent