Aspirin

Product NDC
0363-0227
11-digit product format
003630227
Labeler code
0363
Product ID
0363-0227_dc59a437-ff45-4022-a5da-41f415cd00a4
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Walgreen Company
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1992-12-14
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
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 packagepackage0363-02270363-0227-57DDiscontinued by firm2026-08-17

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…

Additional Listing Data#

Finished product
Yes
Brand name base
Aspirin
Brand name suffix
Enteric Coated, Regular Strength
Listing expiration
2026-12-31

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
198467Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5e1484d3-5be1-40da-a3bf-fb19f7d27d45Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
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
0363-0227-14AspirinEnteric Coated, Regular Strength500 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE50019
0363-0227-57AspirinEnteric Coated, Regular Strength1 in 1 CARTONTABLET, DELAYED RELEASE119
0363-0227-57AspirinEnteric Coated, Regular Strength125 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE12519

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0227-14EA - Each0363-0227fa72a133-c1fc-4231-8631-aa967e063ad212013-02-13
0363-0227-57EA - Each0363-0227ae54bf10-25c0-43d0-9794-34c9d00ffb7312013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76EASPIRIN ENTERIC COATED, REGULAR STRENGTH (ASPIRIN) TABLET, COATED [WALGREEN CO.]4
ASPIRINACTIVE MOIETYR16CO5Y76EASPIRIN ENTERIC COATED, REGULAR STRENGTH (ASPIRIN) TABLET, COATED [WALGREEN CO.]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GASPIRIN ENTERIC COATED, REGULAR STRENGTH (ASPIRIN) TABLET, COATED [WALGREEN CO.]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ASPIRIN ENTERIC COATED, REGULAR STRENGTH (ASPIRIN) TABLET, COATED [WALGREEN CO.]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ASPIRIN ENTERIC COATED, REGULAR STRENGTH (ASPIRIN) TABLET, COATED [WALGREEN CO.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOASPIRIN ENTERIC COATED, REGULAR STRENGTH (ASPIRIN) TABLET, COATED [WALGREEN CO.]4
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEASPIRIN ENTERIC COATED, REGULAR STRENGTH (ASPIRIN) TABLET, COATED [WALGREEN CO.]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AASPIRIN ENTERIC COATED, REGULAR STRENGTH (ASPIRIN) TABLET, COATED [WALGREEN CO.]4
Polyvinyl Acetate PhthalateINACTIVE INGREDIENT58QVG85GW3ASPIRIN ENTERIC COATED, REGULAR STRENGTH (ASPIRIN) TABLET, COATED [WALGREEN CO.]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ASPIRIN ENTERIC COATED, REGULAR STRENGTH (ASPIRIN) TABLET, COATED [WALGREEN CO.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ASPIRIN ENTERIC COATED, REGULAR STRENGTH (ASPIRIN) TABLET, COATED [WALGREEN CO.]4
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQASPIRIN ENTERIC COATED, REGULAR STRENGTH (ASPIRIN) TABLET, COATED [WALGREEN CO.]4
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOASPIRIN ENTERIC COATED, REGULAR STRENGTH (ASPIRIN) TABLET, COATED [WALGREEN CO.]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APASPIRIN ENTERIC COATED, REGULAR STRENGTH (ASPIRIN) TABLET, COATED [WALGREEN CO.]4
TALCINACTIVE INGREDIENT7SEV7J4R1UASPIRIN ENTERIC COATED, REGULAR STRENGTH (ASPIRIN) TABLET, COATED [WALGREEN CO.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPASPIRIN ENTERIC COATED, REGULAR STRENGTH (ASPIRIN) TABLET, COATED [WALGREEN CO.]4
TRIACETININACTIVE INGREDIENTXHX3C3X673ASPIRIN ENTERIC COATED, REGULAR STRENGTH (ASPIRIN) TABLET, COATED [WALGREEN CO.]4
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMASPIRIN ENTERIC COATED, REGULAR STRENGTH (ASPIRIN) TABLET, COATED [WALGREEN CO.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0227ASPIRIN ENTERIC COATED, REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [WALGREEN COMPANY]17Current NDC, Legacy NDC, 3 package rows20240825_5e1484d3-5be1-40da-a3bf-fb19f7d27d45.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 1 of 85 · 1,689 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Pain plus Fever ReliefACETAMINOPHENCVS PHARMACYe4cbfb06-d826-4d08-95d6-60305c4176252026-08-14WarningsExact identifier
application number: M013
Childrens Pain ReliefACETAMINOPHENCVS Pharmacy,Inc.3738d35c-1e83-40df-9292-c54e6b2c83532026-08-14WarningsExact identifier
application number: M013
CVS Childrens Pain plus Fever ReliefACETAMINOPHENCVS PHARMACY22a48a33-995b-481e-9e4e-1ad7ec346f442026-08-14WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENTopco Associates, LLC8b9e90da-98e2-4d8d-bf6e-54b0a8f8d1012026-08-12WarningsExact identifier
application number: M013
Aspirin 81mgASPIRINHARRIS TEETER54e69d5a-55d7-4ebe-8494-0be93613f1e22026-08-12WarningsExact identifier
application number: M013
Chewable AspirinASPIRINHARRIS TEETERc6a28c83-60c9-3304-e053-2a95a90aa06c2026-08-12WarningsExact identifier
application number: M013
ASPIRINASPIRINHARRIS TEETER93cbd3cb-1072-89e6-e053-2995a90a2f152026-08-12WarningsExact identifier
application number: M013
Adult Chewable AspirinASPIRINHARRIS TEETERc6a28617-1769-7a7d-e053-2995a90a1ea02026-08-12WarningsExact identifier
application number: M013
Gencare- Pain Relief AcetaminophenACETAMINOPHENPioneer Life Sciences, LLC2111c91b-2fd7-4ab3-946a-d4e0cf46399a2026-08-12WarningsExact identifier
application number: M013
Pain Reliever Extra StrengthACETAMINOPHENSalado Sales, Inc.1dbd8480-5cb4-4577-9091-b2a2add4f1af2026-08-12WarningsExact identifier
application number: M013
pain relief childrensACETAMINOPHENRite Aid Corporation29ecdd2d-aeaf-40a8-a347-011088009ea62026-08-11WarningsExact identifier
application number: M013
Fast Acting Pedia CraeACETAMINOPHENRandob Labs., Ltd.e069060f-fbb2-4c7a-b872-00b3ab86d01b2026-08-11WarningsExact identifier
application number: M013
ASPIRINASPIRINAmazon.com Services LLCc7cc0681-4c0b-4565-99df-d0168c8ba1ba2026-08-10WarningsExact identifier
application number: M013
GenCare Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEPioneer Life Sciences, LLCac8c4bdf-30c9-2b09-e053-2a95a90a9b672026-08-09WarningsExact identifier
application number: M013
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
berkley and jensen acetaminophenACETAMINOPHENBJWCdee57d73-73ac-48bb-b1da-9971f1ff21c42026-08-07WarningsExact 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198467aspirin 325 MG Delayed Release Oral TabletPSN5e1484d3-5be1-40da-a3bf-fb19f7d27d4519
198467aspirin 325 MG Delayed Release Oral TabletSCD5e1484d3-5be1-40da-a3bf-fb19f7d27d4519
198467ASA 325 MG Delayed Release Oral TabletSY5e1484d3-5be1-40da-a3bf-fb19f7d27d4519
198467aspirin 325 MG Enteric Coated Oral TabletSY5e1484d3-5be1-40da-a3bf-fb19f7d27d4519

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-0227-1400363022714500 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0363-0227-14) 1992-12-140000-00-00NoNoCurrent
0363-0227-57003630227571 in 1 CARTONHistorical