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

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 Regimen Chewable
Brand name suffix
Low Dose Aspirin Orange
Listing expiration
2026-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
318272Internal RxNorm lookup
825180Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0c6ae05f-760f-34d1-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
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

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 10 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEP & L Development, LLC55e996cd-ef22-4e09-a05c-8aa994e4540b2026-06-12WarningsExact identifier
application number: M013
CHILDRENS TYLENOLACETAMINOPHENKenvue Brands LLC3162733b-9382-39f1-e063-6294a90ac4202026-06-12WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENDr. Reddy's Laboratories Inc.9769e0c0-2f4c-3b7a-1a65-c98fbce116812026-06-12WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENNuCare Pharmaceuticals, Inc.54010ddf-25d1-2016-e063-6294a90a877d2026-06-11WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENPreferred Pharmaceuticals Inc.983debdf-4a61-4dde-ba34-567fdd17720e2026-06-11WarningsExact identifier
application number: M013
Acetaminophen Liquid / Acetaminophen Diphenhydramine HCl LiquidACETAMINOPHEN, DIPHENHYDRAMINE HCLWALGREENS40b4fe91-b1dd-147c-e063-6294a90a807d2026-06-09WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPUBLIX SUPERMARKETS, INC3f17fa06-4932-b8ec-e063-6294a90a03812026-06-09WarningsExact identifier
application number: M013
Sleep Aid Plus Pain ReliefACETAMINOPHEN, DIPHENHYDRAMINE HCLWalgreen Companye3929179-dad2-4f7e-a971-dbf80f2b5e1b2026-06-08WarningsExact identifier
application number: M013
LOW DOSE ASPIRINASPIRINPinnacle RX LLC53c11fb4-ba31-b5e5-e063-6394a90a9c1a2026-06-08WarningsExact identifier
application number: M013
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLWalgreen Company9655c38a-126b-459e-b31d-0aa33d9eb5222026-06-08WarningsExact identifier
application number: M013
Acetaminophen Regular StrengthACETAMINOPHENAurohealth LLCdce938f5-eeba-4a76-9261-2b1324c39a312026-06-08WarningsExact identifier
application number: M013
Childrens MapapACETAMINOPHENBryant Ranch Prepack69c90cc8-846a-42cf-933a-108671689e8f2026-06-05WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINRugby Laboratories63fcd93a-b1db-44ba-8f2b-055a7deb205d2026-06-04WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENASCLEMED USA INC.707a9ea7-8f4e-4274-97bd-b8071a0ee06b2026-06-04WarningsExact identifier
application number: M013
Aspirin Adult low doseACETYLSALICYCLIC ACIDMedline Industries, LP6dd6501f-841c-4994-e053-2a91aa0ae2312026-06-04WarningsExact identifier
application number: M013
MedlineACETAMINOPHENMedline Industries, LPfc5e6f2a-e813-0666-e053-6394a90a66a72026-06-04WarningsExact identifier
application number: M013
MedlineACETAMINOPHENMedline Industries, LPfc5d92c2-4bbe-8ad1-e053-6294a90a65b62026-06-04WarningsExact identifier
application number: M013
acetaminophenACETAMINOPHENUnit Dose Solutions, Inc.537219ac-552a-a30e-e063-6394a90aa9d12026-06-04WarningsExact identifier
application number: M013
Pain Relief childrensACETAMINOPHENCVS PHARMACYff878f56-125a-4de7-b063-029f7030733d2026-06-04WarningsExact identifier
application number: M013
Back and Body Extra StrengthASPIRIN, CAFFEINECVS Pharmacy749e2be2-594a-4052-8fa5-45c9ade2d23c2026-06-03WarningsExact identifier
application number: M013

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