FDA.reportPublic FDA data

Bayer Aspirin Regimen Chewable

Product NDC
0280-2080
11-digit product format
002802080
Labeler code
0280
Product ID
0280-2080_32838a17-a0f6-2020-e063-6394a90a9986
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Bayer HealthCare LLC.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-01-11
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Bayer Aspirin Regimen Chewable
Brand name suffix
Low Dose Aspirin Orange
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN81 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR16CO5Y76E
Rxcui318272, 825180

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
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0280-2080-01Bayer Aspirin Regimen ChewableLow Dose Aspirin Orange36 in 1 BOTTLE, PLASTICTABLET, CHEWABLE366
0280-2080-01Bayer Aspirin Regimen ChewableLow Dose Aspirin Orange6 in 1 CARTONTABLET, CHEWABLE66
0280-2080-18Bayer Aspirin Regimen ChewableLow Dose Aspirin Orange18 in 1 BOTTLE, PLASTICTABLET, CHEWABLE186
0280-2080-18Bayer Aspirin Regimen ChewableLow Dose Aspirin Orange1 in 1 CARTONTABLET, CHEWABLE16
0280-2080-36Bayer Aspirin Regimen ChewableLow Dose Aspirin Orange1 in 1 CARTONTABLET, CHEWABLE16
0280-2080-36Bayer Aspirin Regimen ChewableLow Dose Aspirin Orange36 in 1 BOTTLE, PLASTICTABLET, CHEWABLE366

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76EBAYER ASPIRIN REGIMEN CHEWABLE LOW DOSE ASPIRIN ORANGE (ASPIRIN) TABLET, CHEWABLE [BAYER HEALTHCARE LLC, CONSUMER CARE]1
ASPIRINACTIVE MOIETYR16CO5Y76EBAYER ASPIRIN REGIMEN CHEWABLE LOW DOSE ASPIRIN ORANGE (ASPIRIN) TABLET, CHEWABLE [BAYER HEALTHCARE LLC, CONSUMER CARE]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933BAYER ASPIRIN REGIMEN CHEWABLE LOW DOSE ASPIRIN ORANGE (ASPIRIN) TABLET, CHEWABLE [BAYER HEALTHCARE LLC, CONSUMER CARE]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBAYER ASPIRIN REGIMEN CHEWABLE LOW DOSE ASPIRIN ORANGE (ASPIRIN) TABLET, CHEWABLE [BAYER HEALTHCARE LLC, CONSUMER CARE]1
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2BAYER ASPIRIN REGIMEN CHEWABLE LOW DOSE ASPIRIN ORANGE (ASPIRIN) TABLET, CHEWABLE [BAYER HEALTHCARE LLC, CONSUMER CARE]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8BAYER ASPIRIN REGIMEN CHEWABLE LOW DOSE ASPIRIN ORANGE (ASPIRIN) TABLET, CHEWABLE [BAYER HEALTHCARE LLC, CONSUMER CARE]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYBAYER ASPIRIN REGIMEN CHEWABLE LOW DOSE ASPIRIN ORANGE (ASPIRIN) TABLET, CHEWABLE [BAYER HEALTHCARE LLC, CONSUMER CARE]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BAYER ASPIRIN REGIMEN CHEWABLE LOW DOSE ASPIRIN ORANGE (ASPIRIN) TABLET, CHEWABLE [BAYER HEALTHCARE LLC, CONSUMER CARE]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBAYER ASPIRIN REGIMEN CHEWABLE LOW DOSE ASPIRIN ORANGE (ASPIRIN) TABLET, CHEWABLE [BAYER HEALTHCARE LLC, CONSUMER CARE]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0280-2080BAYER ASPIRIN REGIMEN CHEWABLE LOW DOSE ASPIRIN ORANGE (ASPIRIN) TABLET, CHEWABLE [BAYER HEALTHCARE LLC.]6Current NDC, Legacy NDC, 6 package rows20250424_0c6ae05f-760f-34d1-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
318272aspirin 81 MG Chewable TabletPSN0c6ae05f-760f-34d1-e054-00144ff88e886
825180BAYER Low-Dose Aspirin 81 MG Chewable TabletPSN0c6ae05f-760f-34d1-e054-00144ff88e886
825180aspirin 81 MG Chewable Tablet [Bayer Aspirin]SBD0c6ae05f-760f-34d1-e054-00144ff88e886
318272aspirin 81 MG Chewable TabletSCD0c6ae05f-760f-34d1-e054-00144ff88e886
318272ASA 81 MG Chewable TabletSY0c6ae05f-760f-34d1-e054-00144ff88e886
825180ASA 81 MG Chewable Tablet [Bayer Aspirin]SY0c6ae05f-760f-34d1-e054-00144ff88e886
825180Bayer Aspirin 81 MG Chewable TabletSY0c6ae05f-760f-34d1-e054-00144ff88e886
825180Bayer Low Dose Aspirin 81 MG Chewable TabletSY0c6ae05f-760f-34d1-e054-00144ff88e886

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0280-2080-01002802080016 BOTTLE, PLASTIC in 1 CARTON (0280-2080-01) / 36 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC2023-01-23NoNoCurrent
0280-2080-18002802080181 BOTTLE, PLASTIC in 1 CARTON (0280-2080-18) / 18 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC2015-01-110000-00-00NoNoCurrent
0280-2080-36002802080361 BOTTLE, PLASTIC in 1 CARTON (0280-2080-36) / 36 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC2015-01-110000-00-00NoNoCurrent