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 43 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Coated AspirinASPIRINL.N.K. International, Inc.e077fe14-62bb-462b-bfa3-8a83c06c22f12025-07-11WarningsExact identifier
application number: M013
EXTRA PAIN RELIEFACETAMINOPHEN, ASPIRIN AND CAFFEINETIME CAP LABS59482917-f80b-4bed-9218-068b35366eb32025-07-11WarningsExact identifier
application number: M013
Up and Up Childrens acetaminophenACETAMINOPHENTarget Corporation25a476a4-9969-49b3-94bf-b076bada4cea2025-07-10WarningsExact identifier
application number: M013
Tylenol Extra Strength CapletACETAMINOPHENJones Healthcare Group - Packaging Services, Incfba711c1-4e69-49b0-8994-97c455aebcb22025-07-09WarningsExact identifier
application number: M013
good sense pain reliefACETAMINOPHENL. Perrigo Companyaf7ae548-38ad-41d5-b1cb-761cd2e386d32025-07-08WarningsExact identifier
application number: M013
topcare pain reliefACETAMINOPHENTopco Associates LLC6aca88df-d3b5-4a60-b23b-1e66dc41ee7b2025-07-08WarningsExact identifier
application number: M013
equate childrens pain and feverACETAMINOPHENWal-Mart Stores Incf15037a5-4e43-4dd6-93b8-b37a1cc22cd62025-07-07WarningsExact identifier
application number: M013
Childrens Acetaminophen Oral Liquid Grape FlavorACETAMINOPHENAARNA USA INC.39347f5d-2d3c-0c23-e063-6294a90a3a462025-07-05WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENMeijer Distribution Incbe841460-98b4-4448-a494-09ff161fd1312025-07-02WarningsExact identifier
application number: M013
Adult Low Dose AspirinASPIRINAdvanced Rx LLCad0d6a5c-eee9-406c-8d7f-1df9b45f53402025-07-02WarningsExact identifier
application number: M013
EXTRA STRENGHT HEADACHE RELIEFACETAMINOPHEN, ASPIRIN, CAFFEINELil' Drug Store Products, Inc.ec04eb5d-96c0-ddb4-e053-2a95a90a4a922025-07-02WarningsExact identifier
application number: M013
Maximum Strength Cough and Chest Congestion and Nighttime Severe Cold and Flu Combo packDEXTROMETHORPHAN HBR, GUAIFENESIN, ACETAMINOPHEN, DOXYLAMINE SUCCINATEGenexa Inc.18835205-a9e3-15c2-e063-6394a90a81072025-07-02WarningsExact identifier
application number: M013
FeverAllACETAMINOPHENSun Pharmaceutical Industries, Inc.8970b91b-5f3c-4764-9e23-25dcb398d0a72025-07-02WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENMeijer Distribution Inc11c9712d-c3b2-49cd-9c2b-0f57190c954e2025-07-02WarningsExact identifier
application number: M013
Aspirin Regular StrengthASPIRINUnited Natural Foods, Inc. dba UNFI979973c1-661a-4384-8b92-fd901ebde5582025-07-01WarningsExact identifier
application number: M013
Pain and Fever ChildrensACETAMINOPHENCVS Pharmacyf6bbce1c-9790-4ca4-847f-579c594ffe0b2025-07-01WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENWALGREENS07d2e322-2465-79e5-e063-6294a90a5ea42025-06-30WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENDISCOUNT DRUG MART66c0cf26-357b-4722-9100-3b86d507a8cd2025-06-30WarningsExact identifier
application number: M013
ALLERGYDIPHENHYDRAMINE HYDROCHLORIDEKroger Companybc019c9e-8fac-5fd3-e053-2a95a90a7ccd2025-06-25WarningsExact identifier
application number: M013
ACETAMINOPHEN Extra StrengthACETAMINOPHENTIME CAP LABS INCfd24d0e0-4f36-42d3-9149-2fb9576903052025-06-25WarningsExact 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