FDA.reportPublic FDA data

Aspirin

Product NDC
46122-615
Requested package NDC
46122-615-87
11-digit product format
461220615
Labeler code
46122
Product ID
46122-615_df1066bc-2287-4b4f-ac0b-ca475fee7c40
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET
Route
ORAL
Labeler
AmerisourceBergen (Good Neighbor Pharmacy) 46122
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2019-05-31
Marketing end
0000-00-00
Substance
ASPIRIN
Active strength
81 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]
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 packagepackage46122-61546122-615-87DDiscontinued 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 · 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 packagepackage46122-61546122-615-87DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage46122-61546122-615-87DDiscontinued by firmexcluded / 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, Related label table
NDCEffectiveRelated label
46122-615-762020-11-04Drug Facts
46122-615-872020-11-04Drug Facts
46122-615-762020-09-27Drug Facts
46122-615-872020-09-27Drug Facts
46122-615-762020-09-25Drug Facts
46122-615-872020-09-25Drug Facts
46122-615-762020-07-22Drug Facts
46122-615-872020-07-22Drug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-615-76EA - Each46122-615d8cf38fa-42d6-4f71-9bac-ae8930d1193f12021-01-08
46122-615-87EA - Each46122-615265fc4ca-35c9-40bb-92b9-9afd1ea440ce12020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-615ASPIRIN ENTERIC SAFETY-COATED (ASPIRIN) TABLET [AMERISOURCEBERGEN (GOOD NEIGHBOR PHARMACY) 46122]8Legacy NDC20240928_5d58312d-90aa-4efd-b10a-7a0cd02f1461.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
46122-615-87461220615871 BOTTLE, PLASTIC in 1 BOX (46122-615-87) > 300 TABLET in 1 BOTTLE, PLASTIC2019-05-310000-00-00NoNoCurrent