FDA.reportPublic FDA data

Adult Low Dose

Product NDC
71309-003
Requested package NDC
71309-003-25
11-digit product format
713090003
Labeler code
71309
Product ID
71309-003_d906461e-18f9-4572-e053-2a95a90a5d43
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin 81 mg
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Safrel Pharmaceuticals, LLC.
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 packagepackage71309-00371309-003-25IInactivated by FDA2026-10-12

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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
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, Related label table
NDCRelated label
71309-003-02Aspirin 81 mg Enteric Coated Tablets
71309-003-05Aspirin 81 mg Enteric Coated Tablets
71309-003-10Aspirin 81 mg Enteric Coated Tablets
71309-003-25Aspirin 81 mg Enteric Coated Tablets
71309-003-50Aspirin 81 mg Enteric Coated Tablets
71309-003-60Aspirin 81 mg Enteric Coated Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71309-003-01Adult Low Dose1000 in 1 BOTTLETABLET, DELAYED RELEASE10006
71309-003-02Adult Low Dose2 in 1 POUCHTABLET, DELAYED RELEASE26
71309-003-05Adult Low Dose500 in 1 BOTTLETABLET, DELAYED RELEASE5006
71309-003-10Adult Low Dose1000 in 1 BOTTLETABLET, DELAYED RELEASE10006
71309-003-25Adult Low Dose25 in 1 BOXTABLET, DELAYED RELEASE256
71309-003-25Adult Low Dose2 in 1 POUCHTABLET, DELAYED RELEASE26
71309-003-30Adult Low Dose30 in 1 BOTTLETABLET, DELAYED RELEASE306
71309-003-30Adult Low Dose1 in 1 CARTONTABLET, DELAYED RELEASE16
71309-003-50Adult Low Dose50 in 1 BOXTABLET, DELAYED RELEASE506
71309-003-50Adult Low Dose2 in 1 POUCHTABLET, DELAYED RELEASE26
71309-003-60Adult Low Dose60 in 1 BOTTLETABLET, DELAYED RELEASE606
71309-003-60Adult Low Dose1 in 1 CARTONTABLET, DELAYED RELEASE16
71309-003-65Adult Low Dose365 in 1 BOTTLETABLET, DELAYED RELEASE3656

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71309-003ADULT LOW DOSE (ASPIRIN 81 MG) TABLET, DELAYED RELEASE [SAFREL PHARMACEUTICALS, LLC.]6Legacy NDC, 13 package rows20230329_87401db3-7162-b48b-e053-2a95a90ac98f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSN87401db3-7162-b48b-e053-2a95a90ac98f6
308416aspirin 81 MG Delayed Release Oral TabletSCD87401db3-7162-b48b-e053-2a95a90ac98f6
308416ASA 81 MG Delayed Release Oral TabletSY87401db3-7162-b48b-e053-2a95a90ac98f6
308416aspirin 81 MG Enteric Coated Oral TabletSY87401db3-7162-b48b-e053-2a95a90ac98f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71309-003-257130900032525 POUCH in 1 BOX (71309-003-25) > 2 TABLET, DELAYED RELEASE in 1 POUCH25 pouch2017-06-050000-00-00NoNoCurrent