FDA.reportPublic FDA data

Bayer

Product NDC
0280-2100
11-digit product format
002802100
Labeler code
0280
Product ID
0280-2100_4526b594-84b4-b981-e063-6294a90a1aed
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET
Route
ORAL
Labeler
Bayer HealthCare LLC.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2002-07-12
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
Brand name suffix
Low Dose
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
308416Internal RxNorm lookup
794229Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
075b103e-0bb4-4b7a-ac0e-5645bcbd0a07Available 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
0280-2100-12BayerLow Dose120 in 1 BOTTLETABLET1208
0280-2100-12BayerLow Dose1 in 1 CARTONTABLET18
0280-2100-20BayerLow Dose200 in 1 BOTTLETABLET2008
0280-2100-20BayerLow Dose1 in 1 CARTONTABLET18
0280-2100-30BayerLow Dose1 in 1 CARTONTABLET18
0280-2100-30BayerLow Dose300 in 1 BOTTLETABLET3008
0280-2100-32BayerLow Dose32 in 1 BOTTLETABLET328
0280-2100-32BayerLow Dose1 in 1 CARTONTABLET18
0280-2100-40BayerLow Dose1 in 1 CARTONTABLET18
0280-2100-40BayerLow Dose400 in 1 BOTTLETABLET4008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0280-2100-12EA - Each0280-2100db8bca36-42b3-4f34-b938-c46fa231cb9512013-02-13
0280-2100-20EA - Each0280-2100f15ca966-2c1e-4a44-b6fc-f2465fdc3d2f12013-02-13
0280-2100-30EA - Each0280-2100fdf42e42-2287-49a6-a9df-b78a699e448012017-06-15
0280-2100-32EA - Each0280-210012fe1c9b-2be1-44b8-b068-82f8acca90ad12013-02-13
0280-2100-40EA - Each0280-21007722e7b9-93c7-4b43-bdd4-0b53f635c16412013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76EBAYER LOW DOSE (ASPIRIN) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]2
ASPIRINACTIVE MOIETYR16CO5Y76EBAYER LOW DOSE (ASPIRIN) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933BAYER LOW DOSE (ASPIRIN) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]2
BROWN IRON OXIDEINACTIVE INGREDIENT1N032N7MFOBAYER LOW DOSE (ASPIRIN) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZBAYER LOW DOSE (ASPIRIN) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBAYER LOW DOSE (ASPIRIN) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8BAYER LOW DOSE (ASPIRIN) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357BAYER LOW DOSE (ASPIRIN) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOBAYER LOW DOSE (ASPIRIN) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JBAYER LOW DOSE (ASPIRIN) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HBAYER LOW DOSE (ASPIRIN) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]2
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MBAYER LOW DOSE (ASPIRIN) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BAYER LOW DOSE (ASPIRIN) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]2
SHELLACINACTIVE INGREDIENT46N107B71OBAYER LOW DOSE (ASPIRIN) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JBAYER LOW DOSE (ASPIRIN) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBAYER LOW DOSE (ASPIRIN) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]2
TRIACETININACTIVE INGREDIENTXHX3C3X673BAYER LOW DOSE (ASPIRIN) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMBAYER LOW DOSE (ASPIRIN) TABLET [BAYER HEALTHCARE LLC, CONSUMER CARE]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0280-2100BAYER LOW DOSE (ASPIRIN) TABLET [BAYER HEALTHCARE LLC.]7Current NDC, Legacy NDC, 10 package rows20231201_075b103e-0bb4-4b7a-ac0e-5645bcbd0a07.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 42 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens AcetaminophenACETAMINOPHENBryant Ranch Prepack190bb2dc-92b4-4b59-a47f-a0251df8261c2025-07-29WarningsExact identifier
application number: M013
Extra Strength NiteTime Pain ReliefACETAMINOPHEN 500 MG,DIPHENHYDRAMINE HYDROCHLORIDE 25 MG TABLETWALGREENSc25c75c7-157f-1c0d-e053-2995a90a2e3c2025-07-25WarningsExact identifier
application number: M013
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEWalmart Inc.21ab3d58-bb0e-3e51-e063-6294a90ad4152025-07-25WarningsExact identifier
application number: M013
Childrens TYLENOLACETAMINOPHENKenvue Brands LLC3a935584-6045-0a58-e063-6394a90a40c42025-07-23WarningsExact identifier
application number: M013
DR. SANA PAIN AND FEVER FOR ChildrenACETAMINOPHENGADAL Laboratories, Inc8a22a5ba-8623-4cca-8723-52b4954034612025-07-23WarningsExact identifier
application number: M013
DuralginaACETAMINOPHENMenper Distributors Inc.bb31f66c-80a9-4bdb-983b-cef5d21de5ff2025-07-22WarningsExact identifier
application number: M013
GesteiraACETAMINOPHENMenper Distributors, Inc.5a907289-564c-491b-98d5-d7f43eaaa1b22025-07-22WarningsExact identifier
application number: M013
Extra strength Acetaminophen PMACETAMINOPHEN 500MG/ DIPHENHYDRAMINE HCL 25MGTIME CAP LABS INC010c5c98-fc67-a9c3-e063-6394a90aa6402025-07-21WarningsExact identifier
application number: M013
childrens pain and feverACETAMINOPHENMeijer Distribution Inc44d50d79-6e47-429f-8cbe-6fcac46677322025-07-18WarningsExact identifier
application number: M013
ADWE Childrens Pain FeverACETAMINOPHENRARITAN PHARMACEUTICALS INC79a3232f-0211-4c8a-acee-4f87e06ffc262025-07-17WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENWalmart Inc.24d191ca-a0c4-e1a8-e063-6394a90a7a2a2025-07-16WarningsExact identifier
application number: M013
EXTRA STRENGTH HEADACHE RELIEFACETAMINOPHEN ASPIRIN CAFFEINEWAL-MART STORES INCd97073cd-b5d7-8c09-e053-2a95a90a89382025-07-16WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENBETTER LIVING BRANDS LLC.f3005d0c-424e-0ab3-e053-2995a90a1c102025-07-16WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENDemoulas Super Markets, Inc397fa6e1-37b2-8f51-e063-6394a90a7b942025-07-16WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENDemoulas Super Markets, Inc39800c27-f39f-cd60-e063-6394a90acd552025-07-16WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENDemoulas Super Markets, Inc397f2b63-733e-5b44-e063-6394a90a97182025-07-16WarningsExact identifier
application number: M013
EXTRA STRENGTH PAIN RELIEFACETAMINOPHEN, ASPIRIN, CAFFEINEBETTER LIVING BRANDS, LLCeb6026d5-d88a-f6b3-e053-2a95a90a5b202025-07-15WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDESafewayf9597abc-3f01-4b94-8078-228e0b74677e2025-07-15WarningsExact identifier
application number: M013
Berkley and Jensen Pain ReliefACETAMINOPHENBJWCd3ee3341-93b8-487c-921e-2892d213efbb2025-07-15WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINECVS Pharmacy9e459853-5951-4ae7-88a6-85b502e9dd412025-07-14WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSN075b103e-0bb4-4b7a-ac0e-5645bcbd0a078
794229BAYER Aspirin 81 MG Delayed Release Oral TabletPSN075b103e-0bb4-4b7a-ac0e-5645bcbd0a078
794229aspirin 81 MG Delayed Release Oral Tablet [Bayer Aspirin]SBD075b103e-0bb4-4b7a-ac0e-5645bcbd0a078
308416aspirin 81 MG Delayed Release Oral TabletSCD075b103e-0bb4-4b7a-ac0e-5645bcbd0a078
308416ASA 81 MG Delayed Release Oral TabletSY075b103e-0bb4-4b7a-ac0e-5645bcbd0a078
794229ASA 81 MG Delayed Release Oral Tablet [Bayer Aspirin]SY075b103e-0bb4-4b7a-ac0e-5645bcbd0a078
308416aspirin 81 MG Enteric Coated Oral TabletSY075b103e-0bb4-4b7a-ac0e-5645bcbd0a078
794229Bayer Aspirin 81 MG Delayed Release Oral TabletSY075b103e-0bb4-4b7a-ac0e-5645bcbd0a078

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0280-2100-12002802100121 BOTTLE in 1 CARTON (0280-2100-12) / 120 TABLET in 1 BOTTLE1 bottle2002-07-120000-00-00NoNoCurrent
0280-2100-20002802100201 BOTTLE in 1 CARTON (0280-2100-20) / 200 TABLET in 1 BOTTLE1 bottle2002-07-120000-00-00NoNoCurrent
0280-2100-30002802100301 BOTTLE in 1 CARTON (0280-2100-30) / 300 TABLET in 1 BOTTLE1 bottle2002-07-120000-00-00NoNoCurrent
0280-2100-32002802100321 BOTTLE in 1 CARTON (0280-2100-32) / 32 TABLET in 1 BOTTLE1 bottle2002-07-120000-00-00NoNoCurrent
0280-2100-40002802100401 BOTTLE in 1 CARTON (0280-2100-40) / 400 TABLET in 1 BOTTLE1 bottle2002-07-120000-00-00NoNoCurrent