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 72 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dolex Children Pain and Fever	ACETAMINOPHEN	Pharmadel LLC	f9158463-aeb1-5de0-e053-6294a90a748b	2024-03-04	Warnings	Exact identifier application number: M013
SEDALMEX FORTE	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Belmora LLC	33b3508e-4caa-4d05-9b15-cb82a2ee2d4d	2024-02-28	Warnings	Exact identifier application number: M013
Pain Relief	ACETAMINOPHEN	AMERISOURCE BERGEN	2b923a97-836c-4dac-a8c0-3047a35fb62e	2024-02-23	Warnings	Exact identifier application number: M013
Pain Reliever PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	BJWC (Berkley & Jensen / BJ's)	b20a08f3-c9c0-4bd9-8ce0-acb932b5bb86	2024-02-22	Warnings	Exact identifier application number: M013
M-PAP	ACETAMINOPHEN	Bryant Ranch Prepack	31a41976-7f65-42d7-acf5-de9c2c5ca58e	2024-02-20	Warnings	Exact identifier application number: M013
Publix Fast Relief Effervescent - Original Flavor	ASPIRIN	PUBLIX SUPER MARKETS INC.	0a342f72-45fd-3e12-e063-6394a90ae33e	2024-02-16	Warnings	Exact identifier application number: M013
Equaline Effervescent Pain Reliever	ASPIRIN	UNITED NATURAL FOODS, INC. DBA UNFI	0761299a-e913-7665-e063-6394a90a6003	2024-02-16	Warnings	Exact identifier application number: M013
TopCare Effervescent Pain Relief	ASPIRIN	TOPCO ASSOCIATES LLC	075f36e1-110c-e839-e063-6294a90a89d7	2024-02-16	Warnings	Exact identifier application number: M013
Extra Strength Pain Reliever	ACETAMINOPHEN	INGLES MARKETS, INC.	115d0b4f-6f0f-79a9-e063-6394a90ab18a	2024-02-14	Warnings	Exact identifier application number: M013
PANADOL	ACETAMINOPHEN	Haleon US Holdings LLC	e1799765-c247-42b4-ad6a-8ba7d136abf2	2024-02-06	Warnings	Exact identifier application number: M013
Panadol Cold and Flu NonDrowsy	ACETAMINOPHEN AND PHENYLEPRINE HCL	Haleon US Holdings LLC	f626ab17-01c9-4493-ba9e-0c8c11146384	2024-02-06	Warnings	Exact identifier application number: M013
PANADOL Extra	ACETAMINOPHEN AND CAFFEINE	Haleon US Holdings LLC	e5c2d88a-d903-4ca0-b895-f27e791dfc4e	2024-02-06	Warnings	Exact identifier application number: M013
PANADOL Extra Strength	ACETAMINOPHEN	Haleon US Holdings LLC	b2fe7f47-1a2e-40ee-8f8f-38f2028dce1b	2024-02-06	Warnings	Exact identifier application number: M013
PANADOL Extra Strength	ACETAMINOPHEN	Haleon US Holdings LLC	9d384e88-5c11-4600-ac6c-a38371570138	2024-02-06	Warnings	Exact identifier application number: M013
PANADOL	ACETAMINOPHEN	Haleon US Holdings LLC	95801755-db54-4ad7-bec1-52671914f6ca	2024-02-06	Warnings	Exact identifier application number: M013
PANADOL PM	ACETAMINOPHEN AND DIPHENHYDRAMINE HCL	Haleon US Holdings LLC	01e7dddb-755c-4745-b701-edcdb6209064	2024-02-06	Warnings, Adverse reactions	Exact identifier application number: M013
PANADOL PM	ACETAMINOPHEN AND DIPHENHYDRAMINE HCL	Haleon US Holdings LLC	fe7cd1f2-9b00-4ded-99c2-8a152c71093c	2024-02-06	Warnings, Adverse reactions	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	AptaPharma Inc.	9064943f-836f-4853-b6f2-2c4879941eeb	2024-02-02	Warnings	Exact identifier application number: M013
Quality Choice Effervescent Pain Relief	ASPIRIN	CHAIN DRUG MARKETING ASSOCIATION, INC.	079af5d7-1be8-2a93-e063-6294a90a496d	2024-02-01	Warnings	Exact identifier application number: M013
MEDI-FIRST Non-Aspirin	ACETAMINOPHEN	Proficient Rx LP	4c84948d-3a95-4c53-8529-7e7b9d8bb6df	2024-02-01	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