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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0363-0227	0363-0227-57	D	Discontinued by firm		2026-10-23

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`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: Enteric Coated, Regular Strength
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ASPIRIN	325 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
R16CO5Y76E	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198467	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
5e1484d3-5be1-40da-a3bf-fb19f7d27d45	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
d7724692-1155-4cc8-a415-22f5fc4aec35	Product name	6	20220216
bde672ba-4805-28d0-1986-73543d41b412	Product name	2	20210201
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
f212291f-05fe-9603-fc7e-bd73e38ce1e6	Product name	2	20161129
ade821ba-260a-47e2-bd89-743e27ac9906	Product name	1	20161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
182f9ab4-4ab5-c449-200f-87ce2ce8e550	Product name	2	20151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657	Product name	1	20150929
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
2a21311a-89e2-0e83-2ebd-117f9798b2b2	Product name	1	20140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94e	Product name	1	20140508
96c2be53-8e44-452d-56a2-d255b2f1af2d	Product name	1	20140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0363-0227-14	AspirinEnteric Coated, Regular Strength	500 in 1 BOTTLE, PLASTIC	TABLET, DELAYED RELEASE	500	19
0363-0227-57	AspirinEnteric Coated, Regular Strength	1 in 1 CARTON	TABLET, DELAYED RELEASE	1	19
0363-0227-57	AspirinEnteric Coated, Regular Strength	125 in 1 BOTTLE, PLASTIC	TABLET, DELAYED RELEASE	125	19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0363-0227-14	EA - Each	0363-0227	fa72a133-c1fc-4231-8631-aa967e063ad2	1	2013-02-13
0363-0227-57	EA - Each	0363-0227	ae54bf10-25c0-43d0-9794-34c9d00ffb73	1	2013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ASPIRIN	ACTIVE INGREDIENT	R16CO5Y76E	ASPIRIN ENTERIC COATED, REGULAR STRENGTH (ASPIRIN) TABLET, COATED [WALGREEN CO.]	4
ASPIRIN	ACTIVE MOIETY	R16CO5Y76E	ASPIRIN ENTERIC COATED, REGULAR STRENGTH (ASPIRIN) TABLET, COATED [WALGREEN CO.]	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	ASPIRIN ENTERIC COATED, REGULAR STRENGTH (ASPIRIN) TABLET, COATED [WALGREEN CO.]	4
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ASPIRIN ENTERIC COATED, REGULAR STRENGTH (ASPIRIN) TABLET, COATED [WALGREEN CO.]	4
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ASPIRIN ENTERIC COATED, REGULAR STRENGTH (ASPIRIN) TABLET, COATED [WALGREEN CO.]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ASPIRIN ENTERIC COATED, REGULAR STRENGTH (ASPIRIN) TABLET, COATED [WALGREEN CO.]	4
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	ASPIRIN ENTERIC COATED, REGULAR STRENGTH (ASPIRIN) TABLET, COATED [WALGREEN CO.]	4
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ASPIRIN ENTERIC COATED, REGULAR STRENGTH (ASPIRIN) TABLET, COATED [WALGREEN CO.]	4
Polyvinyl Acetate Phthalate	INACTIVE INGREDIENT	58QVG85GW3	ASPIRIN ENTERIC COATED, REGULAR STRENGTH (ASPIRIN) TABLET, COATED [WALGREEN CO.]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ASPIRIN ENTERIC COATED, REGULAR STRENGTH (ASPIRIN) TABLET, COATED [WALGREEN CO.]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ASPIRIN ENTERIC COATED, REGULAR STRENGTH (ASPIRIN) TABLET, COATED [WALGREEN CO.]	4
SODIUM ALGINATE	INACTIVE INGREDIENT	C269C4G2ZQ	ASPIRIN ENTERIC COATED, REGULAR STRENGTH (ASPIRIN) TABLET, COATED [WALGREEN CO.]	4
SODIUM BICARBONATE	INACTIVE INGREDIENT	8MDF5V39QO	ASPIRIN ENTERIC COATED, REGULAR STRENGTH (ASPIRIN) TABLET, COATED [WALGREEN CO.]	4
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	ASPIRIN ENTERIC COATED, REGULAR STRENGTH (ASPIRIN) TABLET, COATED [WALGREEN CO.]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ASPIRIN ENTERIC COATED, REGULAR STRENGTH (ASPIRIN) TABLET, COATED [WALGREEN CO.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ASPIRIN ENTERIC COATED, REGULAR STRENGTH (ASPIRIN) TABLET, COATED [WALGREEN CO.]	4
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	ASPIRIN ENTERIC COATED, REGULAR STRENGTH (ASPIRIN) TABLET, COATED [WALGREEN CO.]	4
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	ASPIRIN ENTERIC COATED, REGULAR STRENGTH (ASPIRIN) TABLET, COATED [WALGREEN CO.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0363-0227	ASPIRIN ENTERIC COATED, REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [WALGREEN COMPANY]	17	Current NDC, Legacy NDC, 3 package rows	20240825_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 71 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Good Sense Effervescent Pain Relief	ASPIRIN	Perrigo Direct, Inc.	103027a7-2f0e-8d8c-e063-6294a90aedc7	2024-03-26	Warnings	Exact identifier application number: M013
rugby infants acetaminophen	ACETAMINOPHEN	Rugby Laboratories	8aa9ac68-ca61-4163-a876-52034138c1ea	2024-03-25	Warnings	Exact identifier application number: M013
Equate Pain Reliever Acetaminophen for Adults 250 mg	ACETAMINOPHEN	Walmart Inc	08a18481-f029-f01f-e063-6294a90aac65	2024-03-21	Warnings	Exact identifier application number: M013
Equate Pain Reliever Acetaminophen for Adults 250 mg	ACETAMINOPHEN	Walmart Inc	0d106fa2-2a77-deb2-e063-6394a90a2dac	2024-03-21	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	872c5220-a379-4dc1-b99c-f11ebb82db35	2024-03-19	Warnings	Exact identifier application number: M013
Pain Reliever PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	79886972-47a4-44c5-a131-1a691a328103	2024-03-19	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	5ffcc78d-9163-4cb4-8811-ae9f0142806a	2024-03-18	Warnings	Exact identifier application number: M013
ASPIRIN LOW DOSE CHEWABLE ORANGE PAIN RELIEVER	ASPIRIN LOW DOSE CHEWABLE ORANGE PAIN RELIEVER	HF Acquisition Co LLC, DBA HealthFirst	13e621dc-b2b4-98fd-e063-6394a90acc75	2024-03-17	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	CVS PHARMACY, INC	097a9c98-a092-400d-9600-6797b0b9a50c	2024-03-15	Warnings	Exact identifier application number: M013
Excedrin PM Triple Action Caplets and Excedrin Tension Headache	ACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE, AND DIPHENHYDRAMINE CITRATE	Haleon US Holdings LLC	978a9d27-6d41-42cb-a193-11314923d2ac	2024-03-14	Warnings	Exact identifier application number: M013
Excedrin PM Triple Action Caplets	ACETAMINOPHEN, ASPIRIN (NSAID) AND DIPHENHYDRAMINE CITRATE	Haleon US Holdings LLC	b3812d27-40af-40d7-864a-dfa4ae34cb9e	2024-03-14	Warnings	Exact identifier application number: M013
Excedrin Extra Strength Pain Reliever	ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE	Haleon US Holdings LLC	691b754c-bafc-47e2-a322-cf56245c01f6	2024-03-14	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	CVS PHARMACY, INC	fdc80b2a-d7c1-4b3d-9a9b-28182c6320de	2024-03-14	Warnings	Exact identifier application number: M013
Pain Relief	ACETAMINOPHEN	QUALITY CHOICE (Chain Drug Marketing Association)	2cde052d-22a4-470f-8d6a-7c17061b8ac8	2024-03-14	Warnings	Exact identifier application number: M013
Excedrin Tension Headache	ACETAMINOPHEN, CAFFEINE	Haleon US Holdings LLC	12c074d1-81ac-47d2-8747-b018cda0058a	2024-03-13	Warnings	Exact identifier application number: M013
Menstrual Complete	ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE	Strive Pharmaceuticals Inc.	78c12459-3b27-4ed0-943d-520794eb438d	2024-03-07	Warnings	Exact identifier application number: M013
Pain Reliever fever Reducer Extra Strength	ACETAMINOPHEN	CVS Pharmacy	7b5263ad-01b7-4fc5-9384-4da8efe89e35	2024-03-06	Warnings	Exact identifier application number: M013
Excedrin Extra Strength Geltabs	ACETAMINOPHEN, ASPRIN, CAFFEINE	Haleon US Holdings LLC	11a8439b-0159-4351-b0f5-fe7fad6a33c0	2024-03-05	Warnings	Exact identifier application number: M013
Winco Foods Effervescent Pain Relief	ASPIRIN	Winco Foods, LLC	128afdd7-a9d1-8957-e063-6294a90af569	2024-03-05	Warnings	Exact identifier application number: M013
Aspirin Low Dose Safety Coated	ASPIRIN	Care One (Retail Business Services, LLC.)	6659e103-fa03-4de0-af42-d2fbd548a87c	2024-03-05	Warnings	Exact identifier application number: M013

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
R16CO5Y76E	ASPIRIN	50-78-2	ASPIRIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198467	aspirin 325 MG Delayed Release Oral Tablet	PSN	5e1484d3-5be1-40da-a3bf-fb19f7d27d45	19
198467	aspirin 325 MG Delayed Release Oral Tablet	SCD	5e1484d3-5be1-40da-a3bf-fb19f7d27d45	19
198467	ASA 325 MG Delayed Release Oral Tablet	SY	5e1484d3-5be1-40da-a3bf-fb19f7d27d45	19
198467	aspirin 325 MG Enteric Coated Oral Tablet	SY	5e1484d3-5be1-40da-a3bf-fb19f7d27d45	19

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0363-0227-14	00363022714	500 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0363-0227-14)	1992-12-14	0000-00-00	No	No	Current
0363-0227-57	00363022757	1 in 1 CARTON					Historical