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
IngredientStrength
ASPIRIN81 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R16CO5Y76EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
609948d6-0f20-4d0c-adc0-6ae72a4f2b7aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57344-080-01Aspirin120 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE1204
57344-080-01Aspirin1 in 1 CARTONTABLET, DELAYED RELEASE14
57344-080-20Aspirin300 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE3004

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76EASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.]1
ASPIRINACTIVE MOIETYR16CO5Y76EASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.]1
BROWN IRON OXIDEINACTIVE INGREDIENT1N032N7MFOASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.]1
DIACETYLATED MONOGLYCERIDESINACTIVE INGREDIENT5Z17386USFASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.]1
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)INACTIVE INGREDIENT87Y6436BKRASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.]1
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13ASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57344-080ASPIRIN TABLET, DELAYED RELEASE [AAA PHARMACEUTICAL, INC.]4Current NDC, Legacy NDC, 3 package rows20240615_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 5 of 83 · 1,657 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
pain relief aspirin Low DoseASPIRINRite Aid Corporationdf7835c9-f10f-40c6-8955-61423d94b6772026-08-05WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINDOLGENCORP, LLC7396c97e-8a51-4a21-8208-f13258b5285c2026-08-05WarningsExact identifier
application number: M013
Pain Relief Regular StrengthACETAMINOPHENRite Aid Corporation3b5d4a5a-8c65-4db1-bf01-e8df6523f45a2026-08-04WarningsExact identifier
application number: M013
childrens acetaminophenACETAMINOPHENWinCo Foods, LLC4749a843-9c93-4edd-9b5f-a1e32666544e2026-08-04WarningsExact identifier
application number: M013
SurviveX Travel Med MODCONVENIENCE KITIntent Brands LLC522da86b-cfd7-dd20-e063-6394a90a51c62026-08-04WarningsExact identifier
application number: M013
Extra Strength Pain Reliever mini softgelsACETAMINOPHEN 500 MGShield Pharmaceuticals Corp0ebb1902-6f8a-4bfb-9f2e-839d43bfca372026-08-04WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENBetter Living Brands, LLC743af02c-c762-42f5-8e01-2f62da15e04e2026-08-04WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENAurohealth LLC9aea8aae-8702-4c93-8b07-69cd252f44d62026-08-03WarningsExact identifier
application number: M013
Pain Relief Acetaminophen 325 mgACETAMINOPHENNUVICARE LLC49a59b79-b8b4-4bf5-a403-0a14751efc552026-08-03WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENAurohealth LLCd4e98f8e-f24c-4bdd-b750-fa4f877fb6212026-07-31WarningsExact identifier
application number: M013
KinderFarms Childrens Pain and FeverACETAMINOPHENKinderFarms, LLC4f86419a-b940-a9c6-e063-6394a90a6a2b2026-07-30WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENFamily Dollar Stores, LLC53f7a9c8-f40e-19b2-e063-6394a90a86952026-07-29WarningsExact identifier
application number: M013
KinderFarms Infants Pain and FeverACETAMINOPHENKinderFarms, LLC5468b149-8fac-8d6a-e063-6294a90a8c512026-07-29WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCVS PHARMACY258975d2-d8e8-407d-9804-df3b37a184e42026-07-29WarningsExact identifier
application number: M013
AspirinASPIRINDolgencorp, Inc. (DOLLAR GENERAL & REXALL)3ba0a9f2-062a-401e-82eb-54383a8223662026-07-29WarningsExact identifier
application number: M013
Aspirin 81mg Enteric CoatedASPIRINCardinal Health 107, LLC277723db-3578-4842-92eb-2de325f876492026-07-28WarningsExact identifier
application number: M013
Aspirin Low Dose ChewableASPIRINBetter Living Brands, LLC7afce7b4-c86a-43f7-83cf-15ebffba2f352026-07-28WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENAurohealth LLCf818996c-36d2-4d3d-af3e-39949157edb92026-07-28WarningsExact identifier
application number: M013
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLL.N.K. International, Inc.03b871e8-3e14-4ed8-a978-45129255b2722026-07-27WarningsExact identifier
application number: M013
Pain Relief Acetaminophen PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HCLRite Aid Corporation17d27771-a112-474f-9a58-29af0d7e1af32026-07-27WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSN609948d6-0f20-4d0c-adc0-6ae72a4f2b7a4
308416aspirin 81 MG Delayed Release Oral TabletSCD609948d6-0f20-4d0c-adc0-6ae72a4f2b7a4
308416ASA 81 MG Delayed Release Oral TabletSY609948d6-0f20-4d0c-adc0-6ae72a4f2b7a4
308416aspirin 81 MG Enteric Coated Oral TabletSY609948d6-0f20-4d0c-adc0-6ae72a4f2b7a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57344-080-01573440080011 BOTTLE, PLASTIC in 1 CARTON (57344-080-01) / 120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC2017-07-010000-00-00NoNoCurrent
57344-080-2057344008020300 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (57344-080-20) 2024-03-15NoNoCurrent