FDA.reportPublic FDA data

Bayer Genuine Aspirin

Product NDC
70264-013
Requested package NDC
70264-013-01
11-digit product format
702640013
Labeler code
70264
Product ID
70264-013_43cb3193-0671-d065-e063-6394a90afd47
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET
Route
ORAL
Labeler
R J General Corporation
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-07-31
Substance
ASPIRIN
Active strength
325 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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-278dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-109bebd1f3094a…5416666fcb17…

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
Bayer Genuine Aspirin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN325 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
211874Internal RxNorm lookup
212033Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
23daa359-d40f-4f64-81be-6d154f41df9fAvailable 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70264-013-012022-12-26C16284748780-19d75b9d0-baa9-f424-e053-dadaa90a57ceBayer Genuine Aspirin ®
70264-013-012020-01-31C16284748780-19d75b9d0-baa9-f424-e053-dadaa90a57ceBayer Genuine Aspirin ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70264-013-01Bayer Genuine Aspirin50 in 1 CARTONTABLET506
70264-013-01Bayer Genuine Aspirin2 in 1 POUCHTABLET26

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70264-013BAYER GENUINE ASPIRIN (ASPIRIN) TABLET [R J GENERAL CORPORATION]5Current NDC, Legacy NDC, 2 package rows20241030_23daa359-d40f-4f64-81be-6d154f41df9f.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 79 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain Relief PM Extra StrengthACETAMINOPHEN 500 MG AND DIPHENHYDRAMINE HCL 25 MGAllegiant Health423a8445-964c-4cdb-889a-f391ca5253e72018-12-31WarningsExact identifier
application number: M013
Cold Multi-Symptom Night-timeACETAMINOPHEN,CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCIAllegiant Health3f020cf2-6011-4216-9b39-0b3dc5f0749c2018-12-26WarningsExact identifier
application number: M013
Aspirin ChewableASPIRIN 81 MGAllegiant Health92b8637b-03a9-461f-b2f6-6eddaa2149532018-12-21WarningsExact identifier
application number: M013
Sinus Headache PEMaximum Strength Non-Drowsy Maximum Strength Non-DrowsyACETAMINOPHEN AND PHENYLEPHRINE HCLAllegiant Healthb04b96e0-d99b-48d1-b8b8-e2fdd8dd3f5f2018-12-21WarningsExact identifier
application number: M013
Clear Choice Regular Strength Pain RelieverACETAMINOPHENAthlete's Needs, Inc.d0d9fda5-5eba-4d51-b505-e93a2ae0bdd72018-12-11WarningsExact identifier
application number: M013
ASPIRIN Enteric CoatedASPIRIN 81 MGAllegiant Health5910a882-eb40-440f-8a30-c21fbce9050e2018-11-07WarningsExact identifier
application number: M013
AspirinASPIRIN 325 MGAllegiant Health88b54062-8b3d-4024-a957-62b3255184b92018-11-07WarningsExact identifier
application number: M013
Aspirin Enteric CoatedASPIRIN 81 MGAllegiant Health3ca60fa3-0a0c-4b3e-a0a2-da527ccf4fe52018-11-07WarningsExact identifier
application number: M013
Tension Headache ReliefTENSION HEADACHE RELIEFAllegiant Healthb431a1a3-39c4-4d6c-afdc-c8b017ad89da2017-11-16WarningsExact identifier
application number: M013
SED-MAXACETAMINOPHEN 500 MG WITH CAFFEINE 65MGCommand Brands, LLC4920a0e9-6f88-4df0-8657-77c95a3b96172017-01-19WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
212033aspirin 325 MG Oral TabletPSN23daa359-d40f-4f64-81be-6d154f41df9f6
211874BAYER Aspirin 325 MG Oral TabletPSN23daa359-d40f-4f64-81be-6d154f41df9f6
211874aspirin 325 MG Oral Tablet [Bayer Aspirin]SBD23daa359-d40f-4f64-81be-6d154f41df9f6
212033aspirin 325 MG Oral TabletSCD23daa359-d40f-4f64-81be-6d154f41df9f6
212033ASA 325 MG Oral TabletSY23daa359-d40f-4f64-81be-6d154f41df9f6
211874ASA 325 MG Oral Tablet [Bayer Aspirin]SY23daa359-d40f-4f64-81be-6d154f41df9f6
211874Bayer Aspirin 325 MG Oral TabletSY23daa359-d40f-4f64-81be-6d154f41df9f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70264-013-017026400130150 POUCH in 1 CARTON (70264-013-01) / 2 TABLET in 1 POUCH50 pouch2014-07-310000-00-00NoNoCurrent