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 52 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equaline Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEUnited Natural Foods, Inc. dba UNFI739237a5-cc62-8ad6-e053-2991aa0a91f82024-12-17WarningsExact identifier
application number: M013
NOTTS - Muscle Aches and PainACETAMINOPHENVIVUNT PHARMA LLCe6741300-4573-2580-e053-2a95a90a599c2024-12-17WarningsExact identifier
application number: M013
Extra Strength Pain Reliever, Caseys 4goodACETAMINOPHEN 500MG, FILM-COATED CAPLETLil' Drug Store Products, Inc.e5fc5340-c224-e02b-e053-2a95a90a52972024-12-16WarningsExact identifier
application number: M013
Pain Reliever, Caseys 4goodACETAMINOPHEN 500 MG, TABLETLil' Drug Store Products, Inc.039d2cf1-57f6-4d9d-e063-6394a90a54922024-12-16WarningsExact identifier
application number: M013
Extra Strength Headache, Caseys 4goodACETAMINOPHEN, ASPIRIN, CAFFEINE TABLETLil' Drug Store Products, Inc.0425c6a8-a3ea-24ad-e063-6294a90ae15a2024-12-16WarningsExact identifier
application number: M013
Lil Drug Store Childrens Pain and FeverACETAMINOPHENLil' Drug Store Products, Inc.5fcd41ad-449f-4090-be19-eae4171de8912024-12-16WarningsExact identifier
application number: M013
Acetaminophen 250mg Aspirin 250mg Caffeine 65mgACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MGCVS Pharmacyb9e75551-1e50-9896-e053-2a95a90aafd42024-12-14WarningsExact identifier
application number: M013
Acetaminophen 250mg Aspirin 250mg Caffeine 65mgACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MGCVS Pharmacyb9e5df0e-06d3-6f72-e053-2995a90a2d072024-12-14WarningsExact identifier
application number: M013
Alka-Seltzer Heartburn and PainANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATEBayer HealthCare LLC.2928e140-c868-5bf5-e063-6394a90ab0242024-12-13WarningsExact identifier
application number: M013
foster and thrive pain relieverACETAMINOPHENStrategic Sourcing Services LLCb8ee568c-80cf-4e35-865e-35516bdab0fd2024-12-13WarningsExact identifier
application number: M013
Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEStrive Pharmaceuticals Inc.c0de0bd2-4868-46dc-a20f-3ca02caaa26b2024-12-11WarningsExact identifier
application number: M013
Rite Aid Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATERite Aidb4797380-9cef-d640-e053-2a95a90a06652024-12-11WarningsExact identifier
application number: M013
Top Value Effervescent Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICAROBONATETower Laboratories Ltd44babed8-cf38-1c12-e054-00144ff8d46c2024-12-11Warnings, Adverse reactionsExact identifier
application number: M013
Best Choice Effervescent Antacid Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEValu Merchandisers Companyb5e2300a-b77b-53cc-e053-2a95a90a7a6e2024-12-11WarningsExact identifier
application number: M013
EXTRA STRENGTH Headache Relief geltabsACETAMINOPHEN, ASPIRIN, CAFFEINEStrive Pharmaceuticals Inc.b432771a-4f7d-4d39-a038-d1561d8f67082024-12-11WarningsExact identifier
application number: M013
Pain Relief ChildrensACETAMINOPHENQUALITY CHOICE (Chain Drug Marketing Association)223ffb2b-3ee5-4118-955b-bc4fa4e8a2e62024-12-10WarningsExact identifier
application number: M013
acetaminophenACETAMINOPHENUNFIe689c9e3-dd4d-c646-e053-2a95a90a4b6a2024-12-09WarningsExact identifier
application number: M013
DrKids Childrens Pain and FeverACETAMINOPHEN 80MG/PIECECalmCo LLCff4b0528-39a0-80d5-e053-6394a90a8a832024-12-07WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENDISCOUNT DRUG MART972f09a7-2aa1-4b1b-a6dc-2c4578a078032024-12-05WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENDISCOUNT DRUG MARTe6feff0a-3347-194d-e053-2a95a90acd202024-12-05WarningsExact 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