Aspirin

Product NDC: 55316-227
11-digit product format: 553160227
Labeler code: 55316
Product ID: 55316-227_f1c55250-5632-4f22-abb3-de26d9c14d5f
Type: HUMAN OTC DRUG
Nonproprietary name: Aspirin
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Healthy Accents (DZA Brands, LLC)
Application: part343
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2013-03-01
Marketing end: 2020-12-31
Substance: ASPIRIN
Active strength: 81 mg/1
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	55316-227		D	Discontinued by firm	2026-10-12
excluded package	package	55316-227	55316-227-12	D	Discontinued by firm	2026-10-12
excluded package	package	55316-227	55316-227-30	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 · 36 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	55316-227-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55316-227-12	`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	55316-227-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	55316-227-12	`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	55316-227-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	55316-227-12	`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	55316-227-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	55316-227-12	`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	55316-227-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	55316-227-12	`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	55316-227-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	55316-227-12	`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	55316-227-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	55316-227-12	`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	55316-227-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	55316-227-12	`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	55316-227-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	55316-227-12	`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	55316-227-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	55316-227-12	`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	55316-227-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	55316-227-12	`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	55316-227-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	55316-227-12	`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	ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)]	4
ASPIRIN	ACTIVE MOIETY	R16CO5Y76E	ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)]	4
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)]	4
BROWN IRON OXIDE	INACTIVE INGREDIENT	1N032N7MFO	ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)]	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)]	4
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)]	4
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)]	4
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)]	4
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)]	4
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)	INACTIVE INGREDIENT	74G4R6TH13	ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)]	4
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)]	4
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)]	4
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)]	4
SHELLAC	INACTIVE INGREDIENT	46N107B71O	ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)]	4
SODIUM BICARBONATE	INACTIVE INGREDIENT	8MDF5V39QO	ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)]	4
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)]	4
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)]	4
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)]	4
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [HEALTHY ACCENTS (DZA BRANDS, LLC)]	4

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
DRUG FACTS	Healthy Accents (DZA Brands, LLC) \| P & L Development, LLC	2019-11-05	HUMAN OTC DRUG LABEL	6

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#