Aspirin

Product NDC: 57344-080
11-digit product format: 573440080
Labeler code: 57344
Product ID: 57344-080_1ac8cf0e-4f03-ff3f-e063-6394a90a5c61
Type: HUMAN OTC DRUG
Nonproprietary name: ASPIRIN
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: AAA Pharmaceutical, Inc.
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2017-07-01
Substance: ASPIRIN
Active strength: 81 mg/1
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Aspirin
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ASPIRIN	81 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
R16CO5Y76E	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
308416	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
609948d6-0f20-4d0c-adc0-6ae72a4f2b7a	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
57344-080-01	Aspirin	120 in 1 BOTTLE, PLASTIC	TABLET, DELAYED RELEASE	120	4
57344-080-01	Aspirin	1 in 1 CARTON	TABLET, DELAYED RELEASE	1	4
57344-080-20	Aspirin	300 in 1 BOTTLE, PLASTIC	TABLET, DELAYED RELEASE	300	4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ASPIRIN	ACTIVE INGREDIENT	R16CO5Y76E	ASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.]	1
ASPIRIN	ACTIVE MOIETY	R16CO5Y76E	ASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	ASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.]	1
BROWN IRON OXIDE	INACTIVE INGREDIENT	1N032N7MFO	ASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	ASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	ASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.]	1
DIACETYLATED MONOGLYCERIDES	INACTIVE INGREDIENT	5Z17386USF	ASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	ASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.]	1
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)	INACTIVE INGREDIENT	87Y6436BKR	ASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.]	1
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)	INACTIVE INGREDIENT	74G4R6TH13	ASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	ASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	ASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	ASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.]	1
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	ASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57344-080	ASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.]	4	Current NDC, Legacy NDC, 3 package rows	20240615_609948d6-0f20-4d0c-adc0-6ae72a4f2b7a.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 10 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	P & L Development, LLC	55e996cd-ef22-4e09-a05c-8aa994e4540b	2026-06-12	Warnings	Exact identifier application number: M013
CHILDRENS TYLENOL	ACETAMINOPHEN	Kenvue Brands LLC	3162733b-9382-39f1-e063-6294a90ac420	2026-06-12	Warnings	Exact identifier application number: M013
Acetaminophen Extra Strength	ACETAMINOPHEN	Dr. Reddy's Laboratories Inc.	9769e0c0-2f4c-3b7a-1a65-c98fbce11681	2026-06-12	Warnings	Exact identifier application number: M013
ACETAMINOPHEN	ACETAMINOPHEN	NuCare Pharmaceuticals, Inc.	54010ddf-25d1-2016-e063-6294a90a877d	2026-06-11	Warnings	Exact identifier application number: M013
ACETAMINOPHEN	ACETAMINOPHEN	Preferred Pharmaceuticals Inc.	983debdf-4a61-4dde-ba34-567fdd17720e	2026-06-11	Warnings	Exact identifier application number: M013
Acetaminophen Liquid / Acetaminophen Diphenhydramine HCl Liquid	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	WALGREENS	40b4fe91-b1dd-147c-e063-6294a90a807d	2026-06-09	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	PUBLIX SUPERMARKETS, INC	3f17fa06-4932-b8ec-e063-6294a90a0381	2026-06-09	Warnings	Exact identifier application number: M013
Sleep Aid Plus Pain Relief	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Walgreen Company	e3929179-dad2-4f7e-a971-dbf80f2b5e1b	2026-06-08	Warnings	Exact identifier application number: M013
LOW DOSE ASPIRIN	ASPIRIN	Pinnacle RX LLC	53c11fb4-ba31-b5e5-e063-6394a90a9c1a	2026-06-08	Warnings	Exact identifier application number: M013
Pain Reliever PM	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Walgreen Company	9655c38a-126b-459e-b31d-0aa33d9eb522	2026-06-08	Warnings	Exact identifier application number: M013
Acetaminophen Regular Strength	ACETAMINOPHEN	Aurohealth LLC	dce938f5-eeba-4a76-9261-2b1324c39a31	2026-06-08	Warnings	Exact identifier application number: M013
Childrens Mapap	ACETAMINOPHEN	Bryant Ranch Prepack	69c90cc8-846a-42cf-933a-108671689e8f	2026-06-05	Warnings	Exact identifier application number: M013
Aspirin Low Dose	ASPIRIN	Rugby Laboratories	63fcd93a-b1db-44ba-8f2b-055a7deb205d	2026-06-04	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	ASCLEMED USA INC.	707a9ea7-8f4e-4274-97bd-b8071a0ee06b	2026-06-04	Warnings	Exact identifier application number: M013
Aspirin Adult low dose	ACETYLSALICYCLIC ACID	Medline Industries, LP	6dd6501f-841c-4994-e053-2a91aa0ae231	2026-06-04	Warnings	Exact identifier application number: M013
Medline	ACETAMINOPHEN	Medline Industries, LP	fc5e6f2a-e813-0666-e053-6394a90a66a7	2026-06-04	Warnings	Exact identifier application number: M013
Medline	ACETAMINOPHEN	Medline Industries, LP	fc5d92c2-4bbe-8ad1-e053-6294a90a65b6	2026-06-04	Warnings	Exact identifier application number: M013
acetaminophen	ACETAMINOPHEN	Unit Dose Solutions, Inc.	537219ac-552a-a30e-e063-6394a90aa9d1	2026-06-04	Warnings	Exact identifier application number: M013
Pain Relief childrens	ACETAMINOPHEN	CVS PHARMACY	ff878f56-125a-4de7-b063-029f7030733d	2026-06-04	Warnings	Exact identifier application number: M013
Back and Body Extra Strength	ASPIRIN, CAFFEINE	CVS Pharmacy	749e2be2-594a-4052-8fa5-45c9ade2d23c	2026-06-03	Warnings	Exact identifier application number: M013

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
308416	aspirin 81 MG Delayed Release Oral Tablet	PSN	609948d6-0f20-4d0c-adc0-6ae72a4f2b7a	4
308416	aspirin 81 MG Delayed Release Oral Tablet	SCD	609948d6-0f20-4d0c-adc0-6ae72a4f2b7a	4
308416	ASA 81 MG Delayed Release Oral Tablet	SY	609948d6-0f20-4d0c-adc0-6ae72a4f2b7a	4
308416	aspirin 81 MG Enteric Coated Oral Tablet	SY	609948d6-0f20-4d0c-adc0-6ae72a4f2b7a	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
57344-080-01	57344008001	1 BOTTLE, PLASTIC in 1 CARTON (57344-080-01) / 120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC	2017-07-01	0000-00-00	No	No	Current
57344-080-20	57344008020	300 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (57344-080-20)	2024-03-15		No	No	Current