FDA.reportPublic FDA data

St. Joseph Low Dose Aspirin

Product NDC
69536-181
11-digit product format
695360181
Labeler code
69536
Product ID
69536-181_1705ba3b-36e3-df62-e063-6394a90ab583
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Foundation Consumer Healthcare
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-02-17
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
2026-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage69536-18169536-181-54DDiscontinued by firm2026-10-20

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…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
St. Joseph Low Dose Aspirin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN81 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308416Internal RxNorm lookup
749795Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
dbf40c7b-ce30-46f0-9dea-2ca8ff1c9f6fAvailable 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
69536-181-12St. Joseph Low Dose Aspirin1 in 1 BOXTABLET, FILM COATED17
69536-181-12St. Joseph Low Dose Aspirin120 in 1 BOTTLETABLET, FILM COATED1207
69536-181-15St. Joseph Low Dose Aspirin1 in 1 BOXTABLET, FILM COATED17
69536-181-15St. Joseph Low Dose Aspirin150 in 1 BOTTLETABLET, FILM COATED1507
69536-181-20St. Joseph Low Dose Aspirin200 in 1 BOTTLETABLET, FILM COATED2007
69536-181-20St. Joseph Low Dose Aspirin1 in 1 BOXTABLET, FILM COATED17
69536-181-36St. Joseph Low Dose Aspirin1 in 1 BOXTABLET, FILM COATED17
69536-181-36St. Joseph Low Dose Aspirin36 in 1 BOTTLETABLET, FILM COATED367
69536-181-54St. Joseph Low Dose Aspirin54 in 1 BOTTLETABLET, FILM COATED547
69536-181-54St. Joseph Low Dose Aspirin1 in 1 BOXTABLET, FILM COATED17
69536-181-65St. Joseph Low Dose Aspirin365 in 1 BOTTLETABLET, FILM COATED3657
69536-181-65St. Joseph Low Dose Aspirin1 in 1 BOXTABLET, FILM COATED17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69536-181-12EA - Each69536-1811d7ff21d-4f1d-4119-9c58-b027d2cdbce912018-07-03
69536-181-20EA - Each69536-18106a01f51-f94d-4687-b440-e7ba86d6cf9a12018-07-03
69536-181-36EA - Each69536-18116b344f7-9fbd-47df-b07c-dc895fd931ee12018-07-03
69536-181-65EA - Each69536-181a3795353-1057-46eb-9524-57c51e491f1712018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69536-181ST. JOSEPH LOW DOSE ASPIRIN (ASPIRIN) TABLET, FILM COATED [FOUNDATION CONSUMER HEALTHCARE]7Current NDC, Legacy NDC, 12 package rows20240430_dbf40c7b-ce30-46f0-9dea-2ca8ff1c9f6f.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 48 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aspirin 81 mgASPIRINAsclemed USA, Inc.878dab20-668b-4d7a-a5f8-794a587564d52025-02-13WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENCVS HEALTH CORPbbc48c9e-7eb8-2c67-e053-2a95a90a85522025-02-13WarningsExact identifier
application number: M013
Dye Free Infants Pain and FeverACETAMINOPHENCVS1fde0f7c-4b5b-ae9c-e063-6394a90afa412025-02-13WarningsExact identifier
application number: M013
NOTTS - Extra Strength 500 mgACETAMINOPHENVIVUNT PHARMA LLCe677f43d-b4ce-e5b0-e053-2a95a90ad67e2025-02-12WarningsExact identifier
application number: M013
Acetaminophen, Aspirin, CaffeineACETAMINOPHEN, ASPIRIN, CAFFEINELEADER/ Cardinal Health 110, Inc.b3773f02-02a9-33c8-e053-2995a90a22352025-02-11WarningsExact identifier
application number: M013
EXTRA STRENGTH ACETAMINOPHENACETAMINOPHENTIME CAP LABORATORIES, INC.c9f80d24-bd05-e1ce-e053-2995a90aa6462025-02-10WarningsExact identifier
application number: M013
Low dose AspirinASPIRIN 81 MG DELAYED RELEASE TABLETSWALGREENSc25c55aa-9932-0a55-e053-2a95a90a3d1e2025-02-10WarningsExact identifier
application number: M013
AeroTab Pain RelieverPAIN RELIEVERAero Healthcare40e2b5ea-a8ea-f1c6-e063-6394a90a1e6f2025-02-10WarningsExact identifier
application number: M013
Enteric Coated Aspirin Regular StrengthASPIRINTime-Cap Labs, Inc5fbd8bb3-46f9-4089-9a21-b6af97a061062025-02-08WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENTIME CAP LABS INCc193dbc0-cc80-4a7c-aa29-457a20edf8352025-02-08WarningsExact identifier
application number: M013
Daytime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBRGenexa Inc.22f23aeb-f874-6e54-e063-6394a90a95652025-02-07WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENBETTER LIVING BRANDS LLC.f3008928-c555-64ad-e053-2995a90a73072025-02-05WarningsExact identifier
application number: M013
Aspirin 81mgASPIRINBETTER LIVING BRANDS LLC.f300dfbc-7137-79d1-e053-2995a90a636e2025-02-05WarningsExact identifier
application number: M013
Low dose aspirin 81mgASPIRINBETTER LIVING BRANDS LLC.f300c30b-ab1a-a1b4-e053-2a95a90a12942025-02-05WarningsExact identifier
application number: M013
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLStrategic Sourcing Services LLC5d174187-cf89-41ff-9a64-10e0276daf172025-02-05WarningsExact identifier
application number: M013
good sense pain reliefACETAMINOPHENBryant Ranch Prepackc226205d-7c3c-49af-b3e2-fc7b09ad78572025-02-05WarningsExact identifier
application number: M013
Dye Free Childrens AcetaminophenACETAMINOPHENPAI Holdings, LLC dba PAI Pharmaa69fca9d-c0a0-4321-bf03-5c8e99cc07cc2025-02-04WarningsExact identifier
application number: M013
TENSION HEADACHE RELIEFACETAMINOPHEN-CAFFEINETARGET CORPORATION8ed1679d-d3a1-11b1-e053-2995a90a61ad2025-01-31WarningsExact identifier
application number: M013
ValuMeds Extra Strength Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINECabinet Health P.B.C.0f864e73-e4b8-4e23-8990-8439ac17bd582025-01-31WarningsExact identifier
application number: M013
Extra Strength Pain RelieverACETAMINOPHEN TABLETS 500 MGWALGREENSc25bfe92-0196-0489-e053-2995a90abea12025-01-30WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSNdbf40c7b-ce30-46f0-9dea-2ca8ff1c9f6f7
749795St. Joseph Aspirin 81 MG Delayed Release Oral TabletPSNdbf40c7b-ce30-46f0-9dea-2ca8ff1c9f6f7
749795aspirin 81 MG Delayed Release Oral Tablet [St. Joseph Aspirin]SBDdbf40c7b-ce30-46f0-9dea-2ca8ff1c9f6f7
308416aspirin 81 MG Delayed Release Oral TabletSCDdbf40c7b-ce30-46f0-9dea-2ca8ff1c9f6f7
308416ASA 81 MG Delayed Release Oral TabletSYdbf40c7b-ce30-46f0-9dea-2ca8ff1c9f6f7
749795ASA 81 MG Delayed Release Oral Tablet [St. Joseph Aspirin]SYdbf40c7b-ce30-46f0-9dea-2ca8ff1c9f6f7
308416aspirin 81 MG Enteric Coated Oral TabletSYdbf40c7b-ce30-46f0-9dea-2ca8ff1c9f6f7
749795St. Joseph Aspirin 81 MG Delayed Release Oral TabletSYdbf40c7b-ce30-46f0-9dea-2ca8ff1c9f6f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69536-181-12695360181121 BOTTLE in 1 BOX (69536-181-12) / 120 TABLET, FILM COATED in 1 BOTTLE1 bottle2017-02-170000-00-00NoNoCurrent
69536-181-15695360181151 BOTTLE in 1 BOX (69536-181-15) / 150 TABLET, FILM COATED in 1 BOTTLE1 bottle2017-02-170000-00-00NoNoCurrent
69536-181-20695360181201 BOTTLE in 1 BOX (69536-181-20) / 200 TABLET, FILM COATED in 1 BOTTLE1 bottle2017-02-170000-00-00NoNoCurrent
69536-181-36695360181361 BOTTLE in 1 BOX (69536-181-36) / 36 TABLET, FILM COATED in 1 BOTTLE1 bottle2017-02-170000-00-00NoNoCurrent
69536-181-546953601815454 in 1 BOTTLEHistorical
69536-181-65695360181651 BOTTLE in 1 BOX (69536-181-65) / 365 TABLET, FILM COATED in 1 BOTTLE1 bottle2017-02-170000-00-00NoNoCurrent