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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bayer Low DoseASPIRINBayer HealthCare LLC.075b103e-0bb4-4b7a-ac0e-5645bcbd0a072025-12-04WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Reye's syndrome Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert Aspirin may cause a severe allergic reaction which may include: hives facial swelling asthma (wheezing) shock Stomach bleeding warning This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Do not use if you are allergic to aspirin or any other pain reliever/fever reducer Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have asthma Ask a doctor or pharmacist before use if you are taking a prescription drug for gout diabetes arthritis Stop use and ask a doctor if an allergic reaction occurs. Seek medical right away. you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better pain gets worse or lasts more than 10 days redness or swelling is present new symptoms occur ringing in the ears or a loss of hearing occurs If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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 Identifiers#

Field, Values table
FieldValues
UniiR16CO5Y76E
Rxcui308416, 794229

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

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