FDA.reportPublic FDA data

Aspirin

Product NDC
70000-0253
11-digit product format
700000253
Labeler code
70000
Product ID
70000-0253_a5bb5d00-5da7-4488-8683-b4ae43a2125f
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cardinal Health 110, LLC. DBA Leader
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1996-02-10
Substance
ASPIRIN
Active strength
325 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
2027-12-31
Current FDA listing
Yes

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70000-025370000-0253-1DDiscontinued by firm2026-10-15
excluded packagepackage70000-025370000-0253-3DDiscontinued by firm2026-10-15

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 · 24 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0570000-0253-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0570000-0253-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2670000-0253-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2670000-0253-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3170000-0253-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3170000-0253-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2870000-0253-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2870000-0253-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2170000-0253-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2170000-0253-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1070000-0253-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1070000-0253-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3170000-0253-3302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3170000-0253-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2070000-0253-3ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2070000-0253-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1070000-0253-30efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1070000-0253-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0870000-0253-3ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0870000-0253-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0370000-0253-3367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0370000-0253-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0970000-0253-3557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0970000-0253-1557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Aspirin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN325 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R16CO5Y76EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
212033Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
318cc982-23a9-4804-b6fb-248f772d7a38Available on FDA.report

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0253-1Aspirin50 in 1 BOTTLETABLET, FILM COATED5015
70000-0253-1Aspirin1 in 1 CARTONTABLET, FILM COATED115
70000-0253-2Aspirin100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10015
70000-0253-3Aspirin300 in 1 BOTTLETABLET, FILM COATED30015
70000-0253-4Aspirin500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0253-1EA - Each70000-0253c7a9a793-9cb3-44d8-ac7c-eb0a19550f9612018-03-08
70000-0253-2EA - Each70000-0253279b4860-6a53-43e4-96bd-9ce79e0e33d412019-01-24
70000-0253-3EA - Each70000-0253c31a544b-9df6-4562-ac14-a22e87f4a1a512019-06-19
70000-0253-4EA - Each70000-02534fb45724-f7c0-4ecc-846a-0232e6ca713112021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0253ASPIRIN TABLET, FILM COATED [CARDINAL HEALTH 110, LLC. DBA LEADER]14Current NDC, Legacy NDC, 5 package rows20250417_318cc982-23a9-4804-b6fb-248f772d7a38.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 4 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gencare-Aspirin Low Dose Pain reliever (NSAID)ASPIRINPioneer Life Sciences, LLC24d4f46a-c7a5-4e94-804f-1e307d8e8cfc2026-08-09WarningsExact identifier
application number: M013
Aspirin 81 mgASPIRINDOLGENCORP, LLCb4064039-2345-4227-b83d-54dc13a838d32026-08-07WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINUnited Natural Foods, Inc. dba UNFI87def9e0-0246-42cf-b8ea-2513d52e9f682026-08-07WarningsExact identifier
application number: M013
berkley and jensen acetaminophenACETAMINOPHENBJWCdee57d73-73ac-48bb-b1da-9971f1ff21c42026-08-07WarningsExact identifier
application number: M013
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLSalado Sales, Inc.aef30709-f33d-48ff-b2d4-0639ffbd1ffd2026-08-07WarningsExact identifier
application number: M013
AspirinASPIRINP & L Development, LLC4cd74cec-a209-4e92-b853-fbe5c95f76782026-08-06WarningsExact identifier
application number: M013
Tension Headache Aspirin-FreeACETAMINOPHEN, CAFFEINERite Aid Corporation093a7c26-f2b1-4416-b193-81133d247d2e2026-08-06WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENKroger Companybc17b2e5-4828-6a2e-e053-2995a90a8c632026-08-05WarningsExact identifier
application number: M013
Infants TYLENOLACETAMINOPHENKenvue Brands LLC997b9551-c222-4a9c-8ba1-09a5f97495fa2026-08-05WarningsExact identifier
application number: M013
Mantra Pain Gel raspberryACETAMINOPHENMOREMED INC.7c8bdf49-a6d2-4e42-b006-375f103fd0ac2026-08-05WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENHARRIS TEETERd2d2846d-4e0b-4d42-b300-60dd3b2cca1b2026-08-05WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENHARRIS TEETER960f5676-d8c5-470b-a663-4b8d152339b42026-08-05WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENHARRIS TEETERa60f6439-2033-4bd2-b78c-6c083414a12b2026-08-05WarningsExact identifier
application number: M013
pain relief PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEHARRIS TEETER0afb6181-d0b1-4845-8230-faabf1b997dc2026-08-05WarningsExact identifier
application number: M013
Acetaminophen PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEHarris Teeter8a3e3439-90ae-4fc9-8ff2-44b8363fa3382026-08-05WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENHarris Teeter50e7b939-e0eb-44ea-82ea-034e844e2c292026-08-05WarningsExact identifier
application number: M013
pain relief aspirin Low DoseASPIRINRite Aid Corporationdf7835c9-f10f-40c6-8955-61423d94b6772026-08-05WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINDOLGENCORP, LLC7396c97e-8a51-4a21-8208-f13258b5285c2026-08-05WarningsExact identifier
application number: M013
Pain Relief Regular StrengthACETAMINOPHENRite Aid Corporation3b5d4a5a-8c65-4db1-bf01-e8df6523f45a2026-08-04WarningsExact identifier
application number: M013
childrens acetaminophenACETAMINOPHENWinCo Foods, LLC4749a843-9c93-4edd-9b5f-a1e32666544e2026-08-04WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
212033aspirin 325 MG Oral TabletPSN318cc982-23a9-4804-b6fb-248f772d7a3815
212033aspirin 325 MG Oral TabletSCD318cc982-23a9-4804-b6fb-248f772d7a3815
212033ASA 325 MG Oral TabletSY318cc982-23a9-4804-b6fb-248f772d7a3815

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0253-1700000253011 BOTTLE in 1 CARTON (70000-0253-1) > 50 TABLET, FILM COATED in 1 BOTTLE1 bottle1996-02-102021-04-10NoNoCurrent
70000-0253-270000025302100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70000-0253-2) 1996-02-100000-00-00NoNoCurrent
70000-0253-370000025303300 TABLET, FILM COATED in 1 BOTTLE (70000-0253-3) 1996-02-102021-10-14NoNoCurrent
70000-0253-470000025304500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70000-0253-4) 1996-02-100000-00-00NoNoCurrent