Enteric Coated Aspirin

Product NDC: 50090-0003
11-digit product format: 500900003
Labeler code: 50090
Product ID: 50090-0003_50479dca-be02-4908-b26e-0438baba8f1c
Type: HUMAN OTC DRUG
Nonproprietary name: Regular Strength
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: part343
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2011-02-04
Marketing end: 0000-00-00
Substance: ASPIRIN
Active strength: 325 mg/1
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	50090-0003		I	Inactivated by FDA	2026-10-15
excluded package	package	50090-0003	50090-0003-1	I	Inactivated by FDA	2026-10-15
excluded package	package	50090-0003	50090-0003-3	I	Inactivated by FDA	2026-10-15
excluded package	package	50090-0003	50090-0003-5	I	Inactivated by FDA	2026-10-15

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 2 · 84 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	50090-0003-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-0003-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-0003-5	`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	50090-0003-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-0003-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-0003-5	`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	50090-0003-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-0003-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-0003-5	`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	50090-0003-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-0003-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-0003-5	`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	50090-0003-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-0003-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-0003-5	`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	50090-0003-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-0003-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-0003-5	`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	50090-0003-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-0003-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-0003-5	`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	50090-0003-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-0003-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-0003-5	`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	50090-0003-3	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50090-0003-1	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50090-0003-5	`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	50090-0003-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50090-0003-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50090-0003-5	`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	50090-0003-3	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50090-0003-1	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50090-0003-5	`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	50090-0003-3	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-0003-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-0003-5	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50090-0003-3	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50090-0003-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50090-0003-5	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50090-0003-3	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50090-0003-1	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50090-0003-5	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50090-0003-3	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50090-0003-1	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50090-0003-5	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d7724692-1155-4cc8-a415-22f5fc4aec35	Product name	6	20220216
bde672ba-4805-28d0-1986-73543d41b412	Product name	2	20210201
f212291f-05fe-9603-fc7e-bd73e38ce1e6	Product name	2	20161129
ade821ba-260a-47e2-bd89-743e27ac9906	Product name	1	20161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550	Product name	2	20151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657	Product name	1	20150929
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-0003-1	2020-01-31	C162847	48780-1	9d75b9d1-1089-f424-e053-dadaa90a57ce	Enteric Coated Aspirin Regular Strength
50090-0003-3	2020-01-31	C162847	48780-1	9d75b9d1-1089-f424-e053-dadaa90a57ce	Enteric Coated Aspirin Regular Strength
50090-0003-5	2020-01-31	C162847	48780-1	9d75b9d1-1089-f424-e053-dadaa90a57ce	Enteric Coated Aspirin Regular Strength

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50090-0003-1	Enteric Coated Aspirin	30 in 1 BOTTLE	TABLET	30	5
50090-0003-3	Enteric Coated Aspirin	100 in 1 BOTTLE	TABLET	100	5
50090-0003-5	Enteric Coated Aspirin	90 in 1 BOTTLE	TABLET	90	5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ASPIRIN	ACTIVE INGREDIENT	R16CO5Y76E	ENTERIC COATED ASPIRIN (REGULAR STRENGTH) TABLET [A-S MEDICATION SOLUTIONS LLC]	1
ASPIRIN	ACTIVE MOIETY	R16CO5Y76E	ENTERIC COATED ASPIRIN (REGULAR STRENGTH) TABLET [A-S MEDICATION SOLUTIONS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ENTERIC COATED ASPIRIN (REGULAR STRENGTH) TABLET [A-S MEDICATION SOLUTIONS LLC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ENTERIC COATED ASPIRIN (REGULAR STRENGTH) TABLET [A-S MEDICATION SOLUTIONS LLC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	ENTERIC COATED ASPIRIN (REGULAR STRENGTH) TABLET [A-S MEDICATION SOLUTIONS LLC]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	ENTERIC COATED ASPIRIN (REGULAR STRENGTH) TABLET [A-S MEDICATION SOLUTIONS LLC]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ENTERIC COATED ASPIRIN (REGULAR STRENGTH) TABLET [A-S MEDICATION SOLUTIONS LLC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ENTERIC COATED ASPIRIN (REGULAR STRENGTH) TABLET [A-S MEDICATION SOLUTIONS LLC]	1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	ENTERIC COATED ASPIRIN (REGULAR STRENGTH) TABLET [A-S MEDICATION SOLUTIONS LLC]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	ENTERIC COATED ASPIRIN (REGULAR STRENGTH) TABLET [A-S MEDICATION SOLUTIONS LLC]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	ENTERIC COATED ASPIRIN (REGULAR STRENGTH) TABLET [A-S MEDICATION SOLUTIONS LLC]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	ENTERIC COATED ASPIRIN (REGULAR STRENGTH) TABLET [A-S MEDICATION SOLUTIONS LLC]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ENTERIC COATED ASPIRIN (REGULAR STRENGTH) TABLET [A-S MEDICATION SOLUTIONS LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ENTERIC COATED ASPIRIN (REGULAR STRENGTH) TABLET [A-S MEDICATION SOLUTIONS LLC]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ENTERIC COATED ASPIRIN (REGULAR STRENGTH) TABLET [A-S MEDICATION SOLUTIONS LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ENTERIC COATED ASPIRIN (REGULAR STRENGTH) TABLET [A-S MEDICATION SOLUTIONS LLC]	1
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	ENTERIC COATED ASPIRIN (REGULAR STRENGTH) TABLET [A-S MEDICATION SOLUTIONS LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-0003	ENTERIC COATED ASPIRIN (REGULAR STRENGTH) TABLET [A-S MEDICATION SOLUTIONS]	5	Legacy NDC, 3 package rows	20170818_c284cf77-656f-4b36-a8b4-4839ef347f13.zip

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	c284cf77-656f-4b36-a8b4-4839ef347f13	5
198467	aspirin 325 MG Delayed Release Oral Tablet	SCD	c284cf77-656f-4b36-a8b4-4839ef347f13	5
198467	ASA 325 MG Delayed Release Oral Tablet	SY	c284cf77-656f-4b36-a8b4-4839ef347f13	5
198467	aspirin 325 MG Enteric Coated Oral Tablet	SY	c284cf77-656f-4b36-a8b4-4839ef347f13	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
50090-0003-1	50090000301	30 in 1 BOTTLE	Historical
50090-0003-3	50090000303	100 in 1 BOTTLE	Historical
50090-0003-5	50090000305	90 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Enteric Coated Aspirin Regular Strength	A-S Medication Solutions	2017-08-18	HUMAN OTC DRUG LABEL	5