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 20 of 83 · 1,657 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Pain and FeverACETAMINOPHENBest Choice (Valu Merchandisers Company)a8a0d9a5-1a36-4ed2-ae9c-7e1a3d674c072026-03-03WarningsExact identifier
application number: M013
pain reliefACETAMINOPHENHyVee Inc6820a515-4004-407b-969b-c4069dc0c3b52026-02-26WarningsExact identifier
application number: M013
Vicks PainQuil LIQUICAPS PAIN RELIEVERACETAMINOPHENThe Procter & Gamble Manufacturing Company4b1b0e2a-0f58-c3b1-e063-6294a90aa1fb2026-02-26WarningsExact identifier
application number: M013
Acetaminophen, Diphenhydramine HydrochlorideACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDELEADER/ Cardinal Health 110, Inc.7be4d67e-1af9-f059-e053-2991aa0a382e2026-02-26WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENNCS HealthCare of KY, LLC dba Vangard Labsf32fc2e9-c0e3-4a25-8399-9cdba6ae8a162026-02-26WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENNCS HealthCare of KY, LLC dba Vangard Labs1f4ac0e6-e986-4c22-8248-0691d64e1a302026-02-26WarningsExact identifier
application number: M013
Childrens Chewable AcetaminophenACETAMINOPHENDiscount Drug Martf413a617-1166-4940-b6ec-fae32238a7802026-02-26WarningsExact identifier
application number: M013
aspirinASPIRINCVS Pharmacybd11081f-c5d1-4c98-8f5a-4c45269df79b2026-02-26WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENNCS HealthCare of KY, LLC dba Vangard Labs19735691-33f3-4e19-85ad-e5f270251ec52026-02-26WarningsExact identifier
application number: M013
Acetaminophen Liquid / Acetaminophen Diphenhydramine HCl LiquidACETAMINOPHEN, DIPHENHYDRAMINE HCLKroger44520aa1-b63f-4239-e063-6394a90a5e142026-02-25WarningsExact identifier
application number: M013
Leader Extra Strength Effervescent Antacid and Pain RelieverASPIRIN, CITRIC ACID, SODIUM BICARBONATECardinal Healthc5d7bf5f-3e59-52f2-e053-2a95a90a4a002026-02-25WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED12fd643d-7c60-453f-a81f-407ed20e87252026-02-25WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDd96a1531-772b-4a5c-89e4-66fff1fa3d782026-02-25WarningsExact identifier
application number: M013
Gentle Care KitZINC OXIDEKenvue Brands LLC4b8f7a5a-2fc4-ea00-e063-6294a90ab95b2026-02-24WarningsExact identifier
application number: M013
Excedrin PM Triple Action Caplets and Excedrin Extra Strength Pain RelieverACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE, AND DIPHENHYDRAMINE CITRATEHaleon US Holdings LLC444fa225-c204-45d1-b3b3-aa5650ee5d072026-02-23WarningsExact identifier
application number: M013
Excedrin Extra Strength and Excedrin Tension HeadacheACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINEHaleon US Holdings LLC2c8df1c7-7864-48df-939c-d9ae22e0f52c2026-02-23WarningsExact identifier
application number: M013
Vicks PainQuil and Vicks PainQuil PM LIQUICAPS PAIN RELIEVERACETAMINOPHEN, DIPHENHYDRAMINE HCLThe Procter & Gamble Manufacturing Company4b829c72-349a-e52c-e063-6394a90aca8d2026-02-23WarningsExact identifier
application number: M013
Equate Childrens Pain and FeverACETAMINOPHENWal-Mart Stores Inc40eedfe9-54e1-40a2-b4a2-55ff708b89cd2026-02-23WarningsExact identifier
application number: M013
Excedrin Rapid ReliefACETAMINOPHENHaleon US Holdings LLC3a36b7ca-396e-cfd8-e063-6294a90a76ab2026-02-22WarningsExact identifier
application number: M013
Vicks PainQuil PM LIQUICAPS PAIN RELIEVER plus NIGHTTIME SLEEP-AIDACETAMINOPHEN, DIPHENHYDRAMINE HCLThe Procter & Gamble Manufacturing Company4b1ad683-9b5a-622f-e063-6294a90a475c2026-02-20WarningsExact 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