FDA.reportPublic FDA data

Aspirin 81 mg

Product NDC
42507-080
11-digit product format
425070080
Labeler code
42507
Product ID
42507-080_48494033-500a-1348-e063-6394a90a8cb2
Type
HUMAN OTC DRUG
Nonproprietary name
ASPIRIN
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
HYVEE INC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-10-22
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
2027-12-31
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 81 mg
Listing expiration
2027-12-31

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
3e602287-565e-a5b9-e063-6294a90abc17Available 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
42507-080-01Aspirin 81 mg120 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE1203
42507-080-01Aspirin 81 mg120 in 1 CARTONTABLET, DELAYED RELEASE1203
42507-080-04Aspirin 81 mg500 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE5003
42507-080-08Aspirin 81 mg2 in 1 CARTONTABLET, DELAYED RELEASE23
42507-080-08Aspirin 81 mg120 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE1203

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 22 of 83 · 1,657 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
basic care aspirinASPIRINAmazon.com Services LLC265c7d85-a666-4234-9c30-ca8e31f4bcb82026-02-03WarningsExact identifier
application number: M013
GOODYS MAXACETAMINOPHEN, ASPIRIN, AND CAFFEINEMedtech Products Inc.02b3a604-3f09-47e7-add1-b9038b3a268b2026-02-02WarningsExact identifier
application number: M013
Nighttime Pain Reliever plus Sleep AidACETAMINOPHEN, DIPHENHYDRAMINE HCLWALMART INC.8dd85a6b-507c-4502-9e55-a40bdf21d3792026-02-02WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENRite Aid Corporation9a647967-f0c6-466e-be70-34fd3de0a8032026-02-02WarningsExact identifier
application number: M013
Pain Reliever Extra StrengthACETAMINOPHENWal-Mart Stores Inc72365264-f9c4-49f0-be64-73d95817d3582026-02-02WarningsExact identifier
application number: M013
Acetaminophen 325mgACETAMINOPHENMarlex Pharmaceuticals Inc4a18168c-dd36-8280-e063-6394a90a7e102026-02-01WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENMarlex Pharmaceuticals Inc4a183b7d-3a1e-5557-e063-6294a90a54932026-02-01WarningsExact identifier
application number: M013
Mejoralito Children CHILDRENACETAMINOPHENOPMX LLC499e2334-fe7b-ed75-e063-6294a90a3e4c2026-01-30WarningsExact identifier
application number: M013
Resfriol-ito ChildrenACETAMINOPHENOPMX LLC49a27970-f497-934d-e063-6394a90a08d92026-01-30WarningsExact identifier
application number: M013
DOLODOLACETAMINOPHEN, ASPIRIN, CAFFEINEOPMX LLC4c3544bb-058d-4585-e063-6394a90a79f42026-01-30WarningsExact identifier
application number: M013
ATAMEL ForteACETAMINOPHENOPMX LLC4988c97a-af39-16a8-e063-6294a90a89932026-01-29WarningsExact identifier
application number: M013
EXTRA STRENGTH PAIN RELEIFACETAMINOPHENStrategic Sourcing Services, LLC0392db17-c4f3-424b-9dee-549fc5df61c52026-01-29WarningsExact identifier
application number: M013
Regular Strength Pain RelieverACETAMINOPHENStrategic Sourcing Services, LLC959db1b0-2d9f-4857-b475-0fa0273652122026-01-29WarningsExact identifier
application number: M013
ASPIRINASPIRINStrategic Sourcing Services LLC8acdbcf9-64a0-4dda-b60e-7e122254ecf32026-01-29WarningsExact identifier
application number: M013
Crocin MAXACETAMINOPHENOPMX LLC498c7d7e-d952-c122-e063-6394a90ae72f2026-01-29WarningsExact identifier
application number: M013
DOLONEURO-TROPASACETAMINOPHEN, CAFFEINEOPMX LLC4c4b0d8c-3195-7d7b-e063-6294a90a8c422026-01-29WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENFOODHOLD U.S.A., LLCbc19bd47-69ea-4bcc-8d28-c043c9d325132026-01-29WarningsExact identifier
application number: M013
Alka-Seltzer Pain ReliefALKA-SELTZER PAIN RELIEFBayer HealthCare LLC.4975f0ff-0480-7fca-e063-6294a90aef2f2026-01-28WarningsExact identifier
application number: M013
Extra Strength Mini Softgels Pain RelieverACETAMINOPHENTHE KROGER COb49aae4f-b040-44a0-be73-cdf45cf14d7e2026-01-28WarningsExact identifier
application number: M013
Extra Strength AcetaminophenACETAMINOPHENPreferred Pharmaceuticals Inc.b25faa8c-2d13-450a-970f-81c17a6330302026-01-28WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSN3e602287-565e-a5b9-e063-6294a90abc173
308416aspirin 81 MG Delayed Release Oral TabletSCD3e602287-565e-a5b9-e063-6294a90abc173
308416ASA 81 MG Delayed Release Oral TabletSY3e602287-565e-a5b9-e063-6294a90abc173
308416aspirin 81 MG Enteric Coated Oral TabletSY3e602287-565e-a5b9-e063-6294a90abc173

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
42507-080-0142507008001120 in 1 BOTTLE, PLASTICHistorical
42507-080-0442507008004500 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (42507-080-04) 2026-01-13NoNoCurrent
42507-080-08425070080082 BOTTLE, PLASTIC in 1 CARTON (42507-080-08) / 120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC2025-10-22NoNoCurrent