Enteric Aspirin

Product NDC: 64092-141
11-digit product format: 640920141
Labeler code: 64092
Product ID: 64092-141_cd5ee83c-ba65-4ea9-916a-3277f4169e74
Type: HUMAN OTC DRUG
Nonproprietary name: Aspirin
Dosage form: TABLET, COATED
Route: ORAL
Labeler: GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.
Application: part343
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 1992-12-14
Marketing end: 0000-00-00
Substance: ASPIRIN
Active strength: 325 mg/1
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	64092-141		D	Discontinued by firm		2026-10-12
excluded package	package	64092-141	64092-141-50	D	Discontinued by firm		2026-10-12

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, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64092-141-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64092-141-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64092-141-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64092-141-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64092-141-50	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64092-141-50	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64092-141-50	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64092-141-50	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64092-141-50	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64092-141-50	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	64092-141-50	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	64092-141-50	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

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

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Healthcare 44-227	GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. \| LNK International, Inc.	2019-10-15	HUMAN OTC DRUG LABEL	9

Enteric Aspirin

NDC auxiliary status#

Observed NDC auxiliary status history#

Reported adverse events (FAERS/openFDA)#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

Related DailyMed Labels#