FDA.reportPublic FDA data

BAYER Aspirin

Product NDC
0280-2020
11-digit product format
002802020
Labeler code
0280
Product ID
0280-2020_4526b08f-a640-90b9-e063-6294a90a1189
Type
HUMAN OTC DRUG
Nonproprietary name
BAYER Aspirin Extra Strength
Dosage form
TABLET
Route
ORAL
Labeler
Bayer HealthCare LLC.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-12-23
Substance
ASPIRIN
Active strength
500 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
BAYER Aspirin
Brand name suffix
Extra Strength Caplets
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN500 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
198471Internal RxNorm lookup
211887Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0ae64cdb-4ea0-23af-e054-00144ff88e88Available 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
0280-2020-10BAYER AspirinExtra Strength Caplets100 in 1 BOTTLE, PLASTICTABLET1006
0280-2020-10BAYER AspirinExtra Strength Caplets1 in 1 CARTONTABLET16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76EBAYER ASPIRIN EXTRA STRENGTH CAPLETS (BAYER ASPIRIN EXTRA STRENGTH) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]1
ASPIRINACTIVE MOIETYR16CO5Y76EBAYER ASPIRIN EXTRA STRENGTH CAPLETS (BAYER ASPIRIN EXTRA STRENGTH) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933BAYER ASPIRIN EXTRA STRENGTH CAPLETS (BAYER ASPIRIN EXTRA STRENGTH) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZBAYER ASPIRIN EXTRA STRENGTH CAPLETS (BAYER ASPIRIN EXTRA STRENGTH) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]1
D&C RED NO. 7INACTIVE INGREDIENTECW0LZ41X8BAYER ASPIRIN EXTRA STRENGTH CAPLETS (BAYER ASPIRIN EXTRA STRENGTH) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKBAYER ASPIRIN EXTRA STRENGTH CAPLETS (BAYER ASPIRIN EXTRA STRENGTH) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOABAYER ASPIRIN EXTRA STRENGTH CAPLETS (BAYER ASPIRIN EXTRA STRENGTH) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOBAYER ASPIRIN EXTRA STRENGTH CAPLETS (BAYER ASPIRIN EXTRA STRENGTH) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]1
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MBAYER ASPIRIN EXTRA STRENGTH CAPLETS (BAYER ASPIRIN EXTRA STRENGTH) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BAYER ASPIRIN EXTRA STRENGTH CAPLETS (BAYER ASPIRIN EXTRA STRENGTH) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]1
SHELLACINACTIVE INGREDIENT46N107B71OBAYER ASPIRIN EXTRA STRENGTH CAPLETS (BAYER ASPIRIN EXTRA STRENGTH) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBAYER ASPIRIN EXTRA STRENGTH CAPLETS (BAYER ASPIRIN EXTRA STRENGTH) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBAYER ASPIRIN EXTRA STRENGTH CAPLETS (BAYER ASPIRIN EXTRA STRENGTH) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]1
TRIACETININACTIVE INGREDIENTXHX3C3X673BAYER ASPIRIN EXTRA STRENGTH CAPLETS (BAYER ASPIRIN EXTRA STRENGTH) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0280-2020BAYER ASPIRIN EXTRA STRENGTH CAPLETS (BAYER ASPIRIN EXTRA STRENGTH) TABLET [BAYER HEALTHCARE LLC.]5Current NDC, Legacy NDC, 2 package rows20231201_0ae64cdb-4ea0-23af-e054-00144ff88e88.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 22 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TYLENOL Regular StrengthACETAMINOPHENKenvue Brands LLC01f41fae-4abb-4b96-ab09-a7d3dfc286cd2026-01-26WarningsExact identifier
application number: M013
pain reliefACETAMINOPHENMeijer Distribution Incec4dbb71-b507-42a3-9b68-14d4b6621ec12026-01-23WarningsExact identifier
application number: M013
Adult Low Dose AspirinASPIRINNCS HealthCare of KY, LLC dba Vangard Labs9105eff0-1c22-4298-8ee5-9fb7a1de12f12026-01-23WarningsExact identifier
application number: M013
Extra Strength Pain ReliefACETAMINOPHENPreferred Pharmaceuticals Inc.c70e3b8e-071d-4b9a-9393-ad8aa09c6b6e2026-01-22WarningsExact identifier
application number: M013
Tylenol Extra StrengthACETAMINOPHENKenvue Brands LLC17cfa99d-abb2-4d77-9e0e-e77109fbb61a2026-01-21WarningsExact identifier
application number: M013
Dr Simi Extra Strength Acetaminophen 250 mg, Aspirin 250 mg, and Caffeine 65 mgACETAMINOPHEN 250 MG, ASPIRIN 250 MG, AND CAFFEINE 65 MGFarmacias De Similares TX LLC48ea0a2c-511b-4805-e063-6394a90a12252026-01-21WarningsExact identifier
application number: M013
childrens mapapACETAMINOPHENMajor Pharmaceuticalsa1b0ccf0-cf24-4b34-b42a-aa1cc1e57f602026-01-20WarningsExact identifier
application number: M013
EXTRA STRENGTH ACETAMINOPHENACETAMINOPHENWALGREENS CO.9b756e4e-6c56-43aa-a5bc-5b649440e7592026-01-20WarningsExact identifier
application number: M013
EXTRA STRENGTH PAIN RELIEVER PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEWALGREENS CO.5a58d620-a0ec-48d7-92dd-3f3f78ec10ea2026-01-20WarningsExact identifier
application number: M013
equate pain relieverACETAMINOPHENWal-Mart Stores Incd4e438c6-80dd-4531-91e6-bc4ca7a8570f2026-01-20WarningsExact identifier
application number: M013
Unishield Extra Strength Non-AspirinACETAMINOPHENUnishieldba0ec1eb-db85-6a7f-e053-2995a90aafe52026-01-19WarningsExact identifier
application number: M013
pain reliefACETAMINOPHENHyVee Inc24acd62f-72b1-418a-b733-7e4888f3c0a32026-01-16WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENCardinal Health 110, LLC. DBA Leaderdd8b13a5-07df-4cec-92c3-1a662b1e1a562026-01-16WarningsExact identifier
application number: M013
EXTRA STRENGTH HEADACHE RELIEFACETAMINOPHEN, ASPIRIN, CAFFEINEWALGREENS7d8f8389-730d-494e-a0af-5a91a3c99e172026-01-16WarningsExact identifier
application number: M013
TENSION HEADACHE RELIEFACETAMINOPHEN AND CAFFEINEWALGREENS54aff6a0-2778-472f-90ba-375d6bce6ee82026-01-16WarningsExact identifier
application number: M013
EXTRA STRENGTH HEADACHE RELIEFACETAMINOPHEN, ASPIRIN, CAFFEINEWALGREENS097fbab7-3886-4e75-b037-f03adcf3859f2026-01-16WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENWALGREENS CO.bdb09e15-8e17-4987-99d0-bab8856a21092026-01-16WarningsExact identifier
application number: M013
acetaminophenACETAMINOPHENHF Acquisition Co LLC, DBA HealthFirst4870ff00-f727-814d-e063-6394a90a6c8e2026-01-15WarningsExact identifier
application number: M013
AspirinASPIRINHyVee Inc957b13a4-4086-459f-8fa0-9708b317fabe2026-01-15WarningsExact identifier
application number: M013
Unisom PM Pain Nighttime Sleep Aid and Pain RelieverACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEChattem, Inc.451daeeb-88a9-44b1-9a2d-1ff0b0ec41cb2026-01-14WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198471aspirin 500 MG Oral TabletPSN0ae64cdb-4ea0-23af-e054-00144ff88e886
211887Bayer Aspirin 500 MG Oral TabletPSN0ae64cdb-4ea0-23af-e054-00144ff88e886
211887aspirin 500 MG Oral Tablet [Bayer Aspirin]SBD0ae64cdb-4ea0-23af-e054-00144ff88e886
198471aspirin 500 MG Oral TabletSCD0ae64cdb-4ea0-23af-e054-00144ff88e886
198471ASA 500 MG Oral TabletSY0ae64cdb-4ea0-23af-e054-00144ff88e886
211887ASA 500 MG Oral Tablet [Bayer Aspirin]SY0ae64cdb-4ea0-23af-e054-00144ff88e886
211887Bayer Aspirin 500 MG Oral TabletSY0ae64cdb-4ea0-23af-e054-00144ff88e886
211887Bayer Extra Strength Aspirin 500 MG Oral TabletSY0ae64cdb-4ea0-23af-e054-00144ff88e886
211887Bayer Plus Aspirin 500 MG Oral TabletSY0ae64cdb-4ea0-23af-e054-00144ff88e886

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0280-2020-10002802020101 BOTTLE, PLASTIC in 1 CARTON (0280-2020-10) / 100 TABLET in 1 BOTTLE, PLASTIC2014-12-230000-00-00NoNoCurrent