Pain Reliever

Product NDC
69517-104
Requested package NDC
69517-104-60
11-digit product format
695170104
Labeler code
69517
Product ID
69517-104_eec766bc-46da-697c-e053-2a95a90acf81
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin 81 mg
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
HealthLife Of USA
Application
part343
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2016-02-09
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 packagepackage69517-10469517-104-60DDiscontinued by firm2026-10-21

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 packagepackage69517-10469517-104-60DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69517-10469517-104-60DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69517-104PAIN RELIEVER (ASPIRIN 81 MG) TABLET, DELAYED RELEASE [HEALTHLIFE OF USA]11Legacy NDC20231205_f0ce670a-179a-462c-ad4f-02129c456ffb.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69517-104-60695170104601 BOTTLE in 1 CARTON (69517-104-60) > 60 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2017-06-050000-00-00NoNoCurrent