FDA.reportPublic FDA data

Low Dose Aspirin

Product NDC
71399-8627
Requested package NDC
71399-8627-2
11-digit product format
713998627
Labeler code
71399
Product ID
71399-8627_c571422d-0fe8-4b6b-e053-2a95a90a8290
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Akron Phama
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-05-12
Marketing end
0000-00-00
Substance
ASPIRIN
Active strength
81 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 packagepackage71399-862771399-8627-2IInactivated by FDA2026-10-05

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 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
71399-8627-12025-03-10Aspirin Low Dose
71399-8627-22025-03-10Aspirin Low Dose
71399-8627-12025-01-30Aspirin Low Dose
71399-8627-22025-01-30Aspirin Low Dose
71399-8627-12023-02-10Aspirin Low Dose
71399-8627-22023-02-10Aspirin Low Dose
71399-8627-12023-01-30Aspirin Low Dose
71399-8627-22023-01-30Aspirin Low Dose

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71399-8627-1Low Dose Aspirin1000 in 1 BOTTLETABLET, COATED10004
71399-8627-2Low Dose Aspirin120 in 1 BOTTLETABLET, COATED1204

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-8627-1EA - Each71399-8627f3306955-787e-4644-b4a5-8b9fa03792e012021-07-15
71399-8627-2EA - Each71399-862711779293-9607-4ff1-b4d8-7f27c6bf3d8e12021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71399-8627LOW DOSE ASPIRIN (ASPIRIN) TABLET, COATED [AKRON PHAMA]3Legacy NDC, 2 package rows20250312_cfe9dc65-dfbb-4c36-a8c9-57bb460a8d97.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSNcfe9dc65-dfbb-4c36-a8c9-57bb460a8d974
308416aspirin 81 MG Delayed Release Oral TabletSCDcfe9dc65-dfbb-4c36-a8c9-57bb460a8d974
308416ASA 81 MG Delayed Release Oral TabletSYcfe9dc65-dfbb-4c36-a8c9-57bb460a8d974
308416aspirin 81 MG Enteric Coated Oral TabletSYcfe9dc65-dfbb-4c36-a8c9-57bb460a8d974

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71399-8627-271399862702120 TABLET, COATED in 1 BOTTLE (71399-8627-2) 2021-05-120000-00-00NoNoCurrent