FDA.reportPublic FDA data

Adult Low Dose Enteric Coated Aspirin

Product NDC
57896-983
Requested package NDC
57896-983-50
11-digit product format
578960983
Labeler code
57896
Product ID
57896-983_ed877525-9f20-3d04-e053-2a95a90a63ae
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Geri-Care Pharmaceutical Corp
Application
part343
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-07-01
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 packagepackage57896-98357896-983-50DDiscontinued by firm2026-10-12

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 · 1 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 packagepackage57896-98357896-983-50DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-983-10EA - Each57896-983326f8d07-fd7c-4516-a41a-6196a89a450512022-03-09
57896-983-12EA - Each57896-983faf8d841-f93c-42f1-8bf7-928051535e5112022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57896-983ADULT LOW DOSE ENTERIC COATED ASPIRIN (ASPIRIN) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP]3Legacy NDC20231031_d21a68ad-981b-b4f9-e053-2995a90a358b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSNe42c611c-2b2e-12b2-e053-2a95a90af00b1
308416aspirin 81 MG Delayed Release Oral TabletPSNf7f8df66-9d5b-7aac-e053-6294a90a03921
308416aspirin 81 MG Delayed Release Oral TabletSCDe42c611c-2b2e-12b2-e053-2a95a90af00b1
308416aspirin 81 MG Delayed Release Oral TabletSCDf7f8df66-9d5b-7aac-e053-6294a90a03921
308416ASA 81 MG Delayed Release Oral TabletSYe42c611c-2b2e-12b2-e053-2a95a90af00b1
308416ASA 81 MG Delayed Release Oral TabletSYf7f8df66-9d5b-7aac-e053-6294a90a03921
308416aspirin 81 MG Enteric Coated Oral TabletSYe42c611c-2b2e-12b2-e053-2a95a90af00b1
308416aspirin 81 MG Enteric Coated Oral TabletSYf7f8df66-9d5b-7aac-e053-6294a90a03921

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57896-983-5057896098350500 TABLET, COATED in 1 BOTTLE (57896-983-50) 2022-04-010000-00-00NoNoCurrent