Regular Strength Aspirin EC

Product NDC: 33261-153
11-digit product format: 332610153
Labeler code: 33261
Product ID: 33261-153_0d38a94d-5641-4615-96ee-28363bda0515
Type: HUMAN OTC DRUG
Nonproprietary name: Aspirin
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Aidarex Pharmaceuticals LLC
Application: part343
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2011-09-09
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	33261-153		I	Inactivated by FDA	2026-10-15
excluded package	package	33261-153	33261-153-02	I	Inactivated by FDA	2026-10-15
excluded package	package	33261-153	33261-153-14	I	Inactivated by FDA	2026-10-15
excluded package	package	33261-153	33261-153-30	I	Inactivated by FDA	2026-10-15
excluded package	package	33261-153	33261-153-60	I	Inactivated by FDA	2026-10-15
excluded package	package	33261-153	33261-153-90	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 3 · 126 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	33261-153-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	33261-153-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	33261-153-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	33261-153-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	33261-153-90	`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	33261-153-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	33261-153-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	33261-153-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	33261-153-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	33261-153-90	`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	33261-153-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	33261-153-14	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	33261-153-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	33261-153-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	33261-153-90	`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	33261-153-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	33261-153-14	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	33261-153-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	33261-153-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	33261-153-90	`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	33261-153-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	33261-153-14	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	33261-153-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	33261-153-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	33261-153-90	`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	33261-153-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	33261-153-14	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	33261-153-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	33261-153-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	33261-153-90	`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	33261-153-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	33261-153-14	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	33261-153-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	33261-153-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	33261-153-90	`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	33261-153-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	33261-153-14	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	33261-153-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	33261-153-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	33261-153-90	`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	33261-153-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	33261-153-14	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	33261-153-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	33261-153-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	33261-153-90	`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	33261-153-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	33261-153-14	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	33261-153-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	33261-153-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	33261-153-90	`ad56d346431e…`	`cc804d4bbf1e…`

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, Related label table
NDC	Related label
33261-153-02	DRUG FACTS
33261-153-14	DRUG FACTS
33261-153-30	DRUG FACTS
33261-153-60	DRUG FACTS
33261-153-90	DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
33261-153-02	Regular Strength Aspirin EC	120 in 1 BOTTLE, PLASTIC	TABLET, DELAYED RELEASE	120	1
33261-153-14	Regular Strength Aspirin EC	14 in 1 BOTTLE, PLASTIC	TABLET, DELAYED RELEASE	14	1
33261-153-30	Regular Strength Aspirin EC	30 in 1 BOTTLE, PLASTIC	TABLET, DELAYED RELEASE	30	1
33261-153-60	Regular Strength Aspirin EC	60 in 1 BOTTLE, PLASTIC	TABLET, DELAYED RELEASE	60	1
33261-153-90	Regular Strength Aspirin EC	90 in 1 BOTTLE, PLASTIC	TABLET, DELAYED RELEASE	90	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
33261-153-14	EA - Each	33261-153	0d000d7b-30e2-4a92-89f2-2ec177b9a4c7	1	2016-09-02
33261-153-30	EA - Each	33261-153	e7a13c64-d6d8-43f0-a813-05e2a253006d	1	2015-10-02
33261-153-60	EA - Each	33261-153	c03e8d40-31f9-4801-a963-799e16d47512	1	2015-10-02
33261-153-90	EA - Each	33261-153	21e0306d-2d90-4b0e-86c5-4032bb3baba4	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ASPIRIN	ACTIVE INGREDIENT	R16CO5Y76E	REGULAR STRENGTH ASPIRIN EC (ASPIRIN) TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
ASPIRIN	ACTIVE MOIETY	R16CO5Y76E	REGULAR STRENGTH ASPIRIN EC (ASPIRIN) TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	REGULAR STRENGTH ASPIRIN EC (ASPIRIN) TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	REGULAR STRENGTH ASPIRIN EC (ASPIRIN) TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	REGULAR STRENGTH ASPIRIN EC (ASPIRIN) TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	REGULAR STRENGTH ASPIRIN EC (ASPIRIN) TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	REGULAR STRENGTH ASPIRIN EC (ASPIRIN) TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
HYPROMELLOSE 2910 (15 MPA.S)	INACTIVE INGREDIENT	36SFW2JZ0W	REGULAR STRENGTH ASPIRIN EC (ASPIRIN) TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	REGULAR STRENGTH ASPIRIN EC (ASPIRIN) TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	REGULAR STRENGTH ASPIRIN EC (ASPIRIN) TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	REGULAR STRENGTH ASPIRIN EC (ASPIRIN) TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	REGULAR STRENGTH ASPIRIN EC (ASPIRIN) TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	REGULAR STRENGTH ASPIRIN EC (ASPIRIN) TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	REGULAR STRENGTH ASPIRIN EC (ASPIRIN) TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	REGULAR STRENGTH ASPIRIN EC (ASPIRIN) TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	REGULAR STRENGTH ASPIRIN EC (ASPIRIN) TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	REGULAR STRENGTH ASPIRIN EC (ASPIRIN) TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	REGULAR STRENGTH ASPIRIN EC (ASPIRIN) TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	REGULAR STRENGTH ASPIRIN EC (ASPIRIN) TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
33261-153	REGULAR STRENGTH ASPIRIN EC (ASPIRIN) TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1	Legacy NDC, 5 package rows	20140321_2316a3ab-b36b-4fc0-9370-b792eef4ad12.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	2316a3ab-b36b-4fc0-9370-b792eef4ad12	1
198467	aspirin 325 MG Delayed Release Oral Tablet	SCD	2316a3ab-b36b-4fc0-9370-b792eef4ad12	1
198467	ASA 325 MG Delayed Release Oral Tablet	SY	2316a3ab-b36b-4fc0-9370-b792eef4ad12	1
198467	aspirin 325 MG Enteric Coated Oral Tablet	SY	2316a3ab-b36b-4fc0-9370-b792eef4ad12	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
33261-153-02	33261015302	120 in 1 BOTTLE, PLASTIC	Historical
33261-153-14	33261015314	14 in 1 BOTTLE, PLASTIC	Historical
33261-153-30	33261015330	30 in 1 BOTTLE, PLASTIC	Historical
33261-153-60	33261015360	60 in 1 BOTTLE, PLASTIC	Historical
33261-153-90	33261015390	90 in 1 BOTTLE, PLASTIC	Historical