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

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 Identifiers#

Field, Values table
FieldValues
UniiR16CO5Y76E
Rxcui198471, 211887

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

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