Aspirin

Product NDC: 36800-027
11-digit product format: 368000027
Labeler code: 36800
Product ID: 36800-027_8a9ec9e2-a846-4f07-9a49-686b169534b0
Type: HUMAN OTC DRUG
Nonproprietary name: Aspirin
Dosage form: TABLET, COATED
Route: ORAL
Labeler: TOP CARE (Topco Associates LLC)
Application: part343
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2013-03-15
Marketing end: 2022-12-30
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	36800-027		D	Discontinued by firm	2026-10-05
excluded package	package	36800-027	36800-027-05	D	Discontinued by firm	2026-10-05
excluded package	package	36800-027	36800-027-12	D	Discontinued by firm	2026-10-05

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 · 45 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	36800-027-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	36800-027-12	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	36800-027-05	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	36800-027-12	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	36800-027-05	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	36800-027-12	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	36800-027-05	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	36800-027-12	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	36800-027-05	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	36800-027-12	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	36800-027-05	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	36800-027-12	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	36800-027-05	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	36800-027-12	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	36800-027-05	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	36800-027-12	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	36800-027-05	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	36800-027-12	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	36800-027-05	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	36800-027-12	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	36800-027-05	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	36800-027-12	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	36800-027-05	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	36800-027-12	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		Y	Unknown FDA exclusion code: Y	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	36800-027-05	Y	Unknown FDA exclusion code: Y	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	36800-027-12	Y	Unknown FDA exclusion code: Y	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	36800-027-12	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	36800-027-05	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		Y	Unknown FDA exclusion code: Y	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	36800-027-12	Y	Unknown FDA exclusion code: Y	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	36800-027-05	Y	Unknown FDA exclusion code: Y	`110d247fa046…`	`a55b01930146…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
36800-027-05	2020-11-10	DRUG FACTS
36800-027-12	2020-11-10	DRUG FACTS
36800-027-05	2020-01-31	DRUG FACTS
36800-027-12	2020-01-31	DRUG FACTS

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
36800-027-12	EA - Each	36800-027	fbfeff7d-7c40-40ac-b996-7f37dae423e0	1	2017-08-11

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 [TOP CARE (TOPCO ASSOCIATES LLC)]	2
ASPIRIN	ACTIVE MOIETY	R16CO5Y76E	ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]	2
BROWN IRON OXIDE	INACTIVE INGREDIENT	1N032N7MFO	ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]	2
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]	2
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)	INACTIVE INGREDIENT	74G4R6TH13	ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]	2
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]	2
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]	2
SODIUM BICARBONATE	INACTIVE INGREDIENT	8MDF5V39QO	ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]	2
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]	2

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-027-05	36800002705	1 BOTTLE, PLASTIC in 1 BOX (36800-027-05) > 500 TABLET, COATED in 1 BOTTLE, PLASTIC	2013-03-15	2022-12-30	No	No	Current
36800-027-12	36800002712	1 BOTTLE, PLASTIC in 1 BOX (36800-027-12) > 120 TABLET, COATED in 1 BOTTLE, PLASTIC	2013-03-15	2022-12-30	No	No	Current