FDA.reportPublic FDA data

Aspirin

Product NDC
0363-0157
11-digit product format
003630157
Labeler code
0363
Product ID
0363-0157_f0381bfa-fd3f-4242-9baf-0b84dfaa4660
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Walgreen Company
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 packagepackage0363-01570363-0157-12DDiscontinued by firm2026-10-23
excluded packagepackage0363-01570363-0157-17DDiscontinued by firm2026-10-23

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 2025-12-050363-0157-12d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-050363-0157-17d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-260363-0157-12f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-260363-0157-17f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-310363-0157-122ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-310363-0157-172ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-280363-0157-12a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-280363-0157-17a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-210363-0157-12cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-210363-0157-17cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-100363-0157-12cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-100363-0157-17cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-310363-0157-12302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-310363-0157-17302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-200363-0157-12ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-200363-0157-17ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100363-0157-120efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-100363-0157-170efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-080363-0157-12ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-080363-0157-17ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-030363-0157-12367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-030363-0157-17367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-090363-0157-12557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-090363-0157-17557ba5c1ecfa…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
Brand name suffix
Regular Strength
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
0b27c0fd-7ea8-4588-9169-5ad4e8df77efAvailable 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
0363-0157-12AspirinRegular Strength100 in 1 BOTTLETABLET, FILM COATED10018
0363-0157-12AspirinRegular Strength1 in 1 CARTONTABLET, FILM COATED118
0363-0157-14AspirinRegular Strength500 in 1 BOTTLETABLET, FILM COATED50018
0363-0157-17AspirinRegular Strength300 in 1 BOTTLETABLET, FILM COATED30018
0363-0157-98AspirinRegular Strength100 in 1 BOTTLETABLET, FILM COATED10018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0157-12EA - Each0363-0157c1df263e-160b-44c3-846e-1b47026abbd212013-07-02
0363-0157-14EA - Each0363-01573fa3e4c3-88ca-4555-ac59-97f896a4ff4912013-07-02
0363-0157-17EA - Each0363-01579be46883-8972-492d-8925-4fcbd1e7cd2112013-07-02
0363-0157-98EA - Each0363-015771183431-ecba-4ae7-a730-70e6729f3f6012015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76EASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, FILM COATED [WALGREEN CO.]3
ASPIRINACTIVE MOIETYR16CO5Y76EASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, FILM COATED [WALGREEN CO.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, FILM COATED [WALGREEN CO.]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, FILM COATED [WALGREEN CO.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, FILM COATED [WALGREEN CO.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, FILM COATED [WALGREEN CO.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0157ASPIRIN REGULAR STRENGTH (ASPIRIN) TABLET, FILM COATED [WALGREEN COMPANY]17Current NDC, Legacy NDC, 5 package rows20240623_0b27c0fd-7ea8-4588-9169-5ad4e8df77ef.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 67 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
topcare infants pain and feverACETAMINOPHENTopco Associates LLCf1e940ef-3cf0-4a5c-8158-156d0e5a680d2024-06-13WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENTrifecta Pharmaceuticals USA LLC026bf664-d598-73de-e063-6394a90a92062024-06-12WarningsExact identifier
application number: M013
Regular Strength Pain ReliefACETAMINOPHENNuCare Pharmaceuticals,Inc.7c73fc75-af9b-177c-e053-2a91aa0ada562024-06-12WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINTopco Associates4a6a1dbb-c813-42fd-9bb8-497aec3394662024-06-11WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEThe Kroger Co.fa234639-caf8-4c52-9ffe-f1c0c057ee5b2024-06-10WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEThe Kroger Co.bc18590d-6481-4efe-8a3b-974f7543b7542024-06-10WarningsExact identifier
application number: M013
ASPIRINASPIRINH-E-B085b35db-62e4-38db-e063-6394a90a97632024-06-07WarningsExact identifier
application number: M013
pain and feverACETAMINOPHENMeijer Distribution Inccbfa2a25-f1e7-491e-9b67-ff2f4ba0b6cf2024-06-07WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEThe Kroger Co.5691ac45-5732-412e-abb8-2bfaac59160e2024-06-07WarningsExact identifier
application number: M013
Cafiaspirina Rapid Headache ReliefASPIRIN, CAFFEINEBelmora LLCd890acec-6528-4fb7-8d59-6c572a3f07862024-06-07WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINETARGET Corporation611bc1ce-460a-44a3-8e2d-b28a399d9a442024-06-06WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENMeijer Distribution Inc033a6153-2651-4703-8a94-def4618381132024-06-05WarningsExact identifier
application number: M013
CareOne Childrens AcetaminophenACETAMINOPHENAmerican Sales Company126ee71a-c408-415b-9a43-502337a910552024-06-05WarningsExact identifier
application number: M013
Tylenol Extra StrengthACETAMINOPHENA-S Medication Solutions85294a70-3233-4ba5-bc36-ee3f2964aebf2024-06-05WarningsExact identifier
application number: M013
Aspirin 81mgASPIRIN 81MGLodaat LLC6a35f38c-a240-4f8c-9a8e-8d283b67b55b2024-06-04WarningsExact identifier
application number: M013
Aspirin 81mgASPIRIN 81MGLodaat LLC1ec12f4b-de05-4990-a7b7-f82d867361de2024-06-04WarningsExact identifier
application number: M013
CareOne Infants AcetaminophenACETAMINOPHENAmerican Sales Company0a28a4f1-d947-489b-be28-36ba10b581cf2024-06-01WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENBryant Ranch Prepack77fb237f-28b5-486b-b9ef-cb324d5cc0bd2024-05-30WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENBryant Ranch Prepackb5053cf5-209d-4106-afc2-cf9af85f4a692024-05-29WarningsExact identifier
application number: M013
topcare infants pain and feverACETAMINOPHENTopco Associates LLCf129bc0e-1ef1-42a8-8668-2ee88ffc85e32024-05-23WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
212033aspirin 325 MG Oral TabletPSN0b27c0fd-7ea8-4588-9169-5ad4e8df77ef18
212033aspirin 325 MG Oral TabletSCD0b27c0fd-7ea8-4588-9169-5ad4e8df77ef18
212033ASA 325 MG Oral TabletSY0b27c0fd-7ea8-4588-9169-5ad4e8df77ef18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0157-12003630157121 BOTTLE in 1 CARTON (0363-0157-12) > 100 TABLET, FILM COATED in 1 BOTTLE1 bottle1996-02-102021-03-19NoNoCurrent
0363-0157-1400363015714500 TABLET, FILM COATED in 1 BOTTLE (0363-0157-14) 1996-02-100000-00-00NoNoCurrent
0363-0157-1700363015717300 in 1 BOTTLEHistorical
0363-0157-9800363015798100 TABLET, FILM COATED in 1 BOTTLE (0363-0157-98) 1996-02-100000-00-00NoNoCurrent