FDA.reportPublic FDA data

Aspirin 81 mg Enteric Coated

Product NDC
10135-173
Requested package NDC
10135-173-62
11-digit product format
101350173
Labeler code
10135
Product ID
10135-173_555052ca-376e-4277-9c5c-4c76974f9447
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET
Route
ORAL
Labeler
Marlex Pharmaceuticals Inc
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2018-08-01
Marketing end
0000-00-00
Substance
ASPIRIN
Active strength
81 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
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 packagepackage10135-17310135-173-62IInactivated 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 · 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
910c1bd7-67d1-44c7-ad4f-9445f827edccProduct name120230808
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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10135-173-622025-01-30C16284748780-12cef2736-7cf5-d83d-e063-dadaa90ab31fAspirin USP 81mg Enteric Coated Tablet

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-173-62Aspirin 81 mg Enteric Coated120 in 1 BOTTLETABLET1202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-173-62EA - Each10135-1733bc4f031-7966-4bbc-b845-7562bf7b681112018-11-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76EASPIRIN LOW DOSE (ASPIRIN) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1
ASPIRINACTIVE MOIETYR16CO5Y76EASPIRIN LOW DOSE (ASPIRIN) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-173ASPIRIN 81 MG ENTERIC COATED (ASPIRIN) TABLET [MARLEX PHARMACEUTICALS INC]2Legacy NDC, 1 package rows20191112_660b80f4-58a6-4d7a-b8a8-f382f940f6da.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSN660b80f4-58a6-4d7a-b8a8-f382f940f6da2
308416aspirin 81 MG Delayed Release Oral TabletSCD660b80f4-58a6-4d7a-b8a8-f382f940f6da2
308416ASA 81 MG Delayed Release Oral TabletSY660b80f4-58a6-4d7a-b8a8-f382f940f6da2
308416aspirin 81 MG Enteric Coated Oral TabletSY660b80f4-58a6-4d7a-b8a8-f382f940f6da2
308416aspirin 81 MG Delayed Release Oral TabletPSN5af27c8a-9b53-49fd-a518-fa95053b11da1
308416aspirin 81 MG Delayed Release Oral TabletSCD5af27c8a-9b53-49fd-a518-fa95053b11da1
308416ASA 81 MG Delayed Release Oral TabletSY5af27c8a-9b53-49fd-a518-fa95053b11da1
308416aspirin 81 MG Enteric Coated Oral TabletSY5af27c8a-9b53-49fd-a518-fa95053b11da1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10135-173-6210135017362120 TABLET in 1 BOTTLE (10135-173-62) 120 tablet2018-08-010000-00-00NoNoCurrent