FDA.reportPublic FDA data

Regular Strength Enteric coated aspirin

Product NDC
50090-4462
Requested package NDC
50090-4462-3
11-digit product format
500904462
Labeler code
50090
Product ID
50090-4462_7e52a07a-f3c5-470a-b8a2-5dea81bf53a7
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2000-07-01
Marketing end
0000-00-00
Substance
ASPIRIN
Active strength
325 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
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 packagepackage50090-446250090-4462-3IInactivated by FDA2026-10-15

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 · 15 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…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4462-12023-01-30C16284748780-1f386c649-d60f-0266-e053-dadaa90a7c1agc 921
50090-4462-32023-01-30C16284748780-1f386c649-d60f-0266-e053-dadaa90a7c1agc 921
50090-4462-52023-01-30C16284748780-1f386c649-d60f-0266-e053-dadaa90a7c1agc 921

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4462-1Regular Strength Enteric coated aspirin30 in 1 BOTTLETABLET, COATED303
50090-4462-3Regular Strength Enteric coated aspirin100 in 1 BOTTLETABLET, COATED1003
50090-4462-5Regular Strength Enteric coated aspirin90 in 1 BOTTLETABLET, COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4462-1EA - Each50090-44628fa8822c-f813-44ab-81c4-3bfdc8b8fa5612022-07-06
50090-4462-3EA - Each50090-4462d835300e-fd90-4c7a-9abe-079fceb8416e12022-07-06
50090-4462-5EA - Each50090-4462ea7582a9-e6f0-4c5d-b51a-63e6e8f7195012022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4462REGULAR STRENGTH ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [A-S MEDICATION SOLUTIONS]3Legacy NDC, 3 package rows20210303_70f40469-c248-4c9d-bb13-30f9632ce3d7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198467aspirin 325 MG Delayed Release Oral TabletPSN70f40469-c248-4c9d-bb13-30f9632ce3d73
198467aspirin 325 MG Delayed Release Oral TabletSCD70f40469-c248-4c9d-bb13-30f9632ce3d73
198467ASA 325 MG Delayed Release Oral TabletSY70f40469-c248-4c9d-bb13-30f9632ce3d73
198467aspirin 325 MG Enteric Coated Oral TabletSY70f40469-c248-4c9d-bb13-30f9632ce3d73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4462-350090446203100 TABLET, COATED in 1 BOTTLE (50090-4462-3) 2019-08-120000-00-00NoNoCurrent