FDA.reportPublic FDA data

Low dose Aspirin

Product NDC
0363-0690
11-digit product format
003630690
Labeler code
0363
Product ID
0363-0690_2cea1dfd-7b3e-9c49-e063-6394a90a29a1
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin 81 mg Delayed Release Tablets
Dosage form
TABLET
Route
ORAL
Labeler
WALGREENS
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-10-08
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

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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0363-0690-20302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0363-0690-31302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0363-0690-29302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0363-0690-32302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0363-0690-12302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0363-0690-20ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0363-0690-31ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0363-0690-29ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0363-0690-32ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0363-0690-12ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0363-0690-200efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0363-0690-310efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0363-0690-290efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0363-0690-320efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0363-0690-120efc9e666f02…f202fb6c5f17…

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
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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c25c3524-3e24-3410-e053-2995a90a73edAvailable 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
0363-0690-122025-02-11481R WALGREENS 0363 0690 Aspirin 81 mg Tablet
0363-0690-202025-02-11481R WALGREENS 0363 0690 Aspirin 81 mg Tablet
0363-0690-292025-02-11481R WALGREENS 0363 0690 Aspirin 81 mg Tablet
0363-0690-312025-02-11481R WALGREENS 0363 0690 Aspirin 81 mg Tablet
0363-0690-322025-02-11481R WALGREENS 0363 0690 Aspirin 81 mg Tablet
0363-0690-122025-01-30481R WALGREENS 0363 0690 Aspirin 81 mg Tablet
0363-0690-202025-01-30481R WALGREENS 0363 0690 Aspirin 81 mg Tablet
0363-0690-292025-01-30481R WALGREENS 0363 0690 Aspirin 81 mg Tablet
0363-0690-312025-01-30481R WALGREENS 0363 0690 Aspirin 81 mg Tablet
0363-0690-322025-01-30481R WALGREENS 0363 0690 Aspirin 81 mg Tablet

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0690-12Low dose Aspirin1 in 1 CARTONTABLET15
0363-0690-12Low dose Aspirin120 in 1 BOTTLETABLET1205
0363-0690-20Low dose Aspirin200 in 1 BOTTLETABLET2005
0363-0690-20Low dose Aspirin1 in 1 CARTONTABLET15
0363-0690-29Low dose Aspirin120 in 1 BOTTLETABLET1205
0363-0690-29Low dose Aspirin2 in 1 CARTONTABLET25
0363-0690-31Low dose Aspirin1 in 1 CARTONTABLET15
0363-0690-31Low dose Aspirin300 in 1 BOTTLETABLET3005
0363-0690-32Low dose Aspirin1 in 1 CARTONTABLET15
0363-0690-32Low dose Aspirin32 in 1 BOTTLETABLET325

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0690-31EA - Each0363-06902d094aea-2cdc-4fb4-b423-4de900f252a012025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0690LOW DOSE ASPIRIN (ASPIRIN 81 MG DELAYED RELEASE TABLETS) TABLET [WALGREENS]5Current NDC, Legacy NDC, 10 package rows20250213_c25c3524-3e24-3410-e053-2995a90a73ed.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 10 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEP & L Development, LLC55e996cd-ef22-4e09-a05c-8aa994e4540b2026-06-12WarningsExact identifier
application number: M013
CHILDRENS TYLENOLACETAMINOPHENKenvue Brands LLC3162733b-9382-39f1-e063-6294a90ac4202026-06-12WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENDr. Reddy's Laboratories Inc.9769e0c0-2f4c-3b7a-1a65-c98fbce116812026-06-12WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENNuCare Pharmaceuticals, Inc.54010ddf-25d1-2016-e063-6294a90a877d2026-06-11WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENPreferred Pharmaceuticals Inc.983debdf-4a61-4dde-ba34-567fdd17720e2026-06-11WarningsExact identifier
application number: M013
Acetaminophen Liquid / Acetaminophen Diphenhydramine HCl LiquidACETAMINOPHEN, DIPHENHYDRAMINE HCLWALGREENS40b4fe91-b1dd-147c-e063-6294a90a807d2026-06-09WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPUBLIX SUPERMARKETS, INC3f17fa06-4932-b8ec-e063-6294a90a03812026-06-09WarningsExact identifier
application number: M013
Sleep Aid Plus Pain ReliefACETAMINOPHEN, DIPHENHYDRAMINE HCLWalgreen Companye3929179-dad2-4f7e-a971-dbf80f2b5e1b2026-06-08WarningsExact identifier
application number: M013
LOW DOSE ASPIRINASPIRINPinnacle RX LLC53c11fb4-ba31-b5e5-e063-6394a90a9c1a2026-06-08WarningsExact identifier
application number: M013
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLWalgreen Company9655c38a-126b-459e-b31d-0aa33d9eb5222026-06-08WarningsExact identifier
application number: M013
Acetaminophen Regular StrengthACETAMINOPHENAurohealth LLCdce938f5-eeba-4a76-9261-2b1324c39a312026-06-08WarningsExact identifier
application number: M013
Childrens MapapACETAMINOPHENBryant Ranch Prepack69c90cc8-846a-42cf-933a-108671689e8f2026-06-05WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINRugby Laboratories63fcd93a-b1db-44ba-8f2b-055a7deb205d2026-06-04WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENASCLEMED USA INC.707a9ea7-8f4e-4274-97bd-b8071a0ee06b2026-06-04WarningsExact identifier
application number: M013
Aspirin Adult low doseACETYLSALICYCLIC ACIDMedline Industries, LP6dd6501f-841c-4994-e053-2a91aa0ae2312026-06-04WarningsExact identifier
application number: M013
MedlineACETAMINOPHENMedline Industries, LPfc5e6f2a-e813-0666-e053-6394a90a66a72026-06-04WarningsExact identifier
application number: M013
MedlineACETAMINOPHENMedline Industries, LPfc5d92c2-4bbe-8ad1-e053-6294a90a65b62026-06-04WarningsExact identifier
application number: M013
acetaminophenACETAMINOPHENUnit Dose Solutions, Inc.537219ac-552a-a30e-e063-6394a90aa9d12026-06-04WarningsExact identifier
application number: M013
Pain Relief childrensACETAMINOPHENCVS PHARMACYff878f56-125a-4de7-b063-029f7030733d2026-06-04WarningsExact identifier
application number: M013
Back and Body Extra StrengthASPIRIN, CAFFEINECVS Pharmacy749e2be2-594a-4052-8fa5-45c9ade2d23c2026-06-03WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSNc25c3524-3e24-3410-e053-2995a90a73ed5
308416aspirin 81 MG Delayed Release Oral TabletSCDc25c3524-3e24-3410-e053-2995a90a73ed5
308416ASA 81 MG Delayed Release Oral TabletSYc25c3524-3e24-3410-e053-2995a90a73ed5
308416aspirin 81 MG Enteric Coated Oral TabletSYc25c3524-3e24-3410-e053-2995a90a73ed5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0690-12003630690121 BOTTLE in 1 CARTON (0363-0690-12) / 120 TABLET in 1 BOTTLE1 bottle2021-10-080000-00-00NoNoCurrent
0363-0690-20003630690201 BOTTLE in 1 CARTON (0363-0690-20) / 200 TABLET in 1 BOTTLE1 bottle2022-06-150000-00-00NoNoCurrent
0363-0690-29003630690292 BOTTLE in 1 CARTON (0363-0690-29) / 120 TABLET in 1 BOTTLE2 bottle2022-06-150000-00-00NoNoCurrent
0363-0690-31003630690311 BOTTLE in 1 CARTON (0363-0690-31) / 300 TABLET in 1 BOTTLE1 bottle2022-06-150000-00-00NoNoCurrent
0363-0690-32003630690321 BOTTLE in 1 CARTON (0363-0690-32) / 32 TABLET in 1 BOTTLE1 bottle2022-06-150000-00-00NoNoCurrent