aspirin

Product NDC
0904-4040
11-digit product format
009044040
Labeler code
0904
Product ID
0904-4040_6df8fec2-6cf9-4c90-98b5-3d53901f21d6
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2007-12-12
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
aspirinASPIRINMajor Pharmaceuticals58684138-04d1-44a4-bc52-c5b85d93d7a62024-08-23WarningsExact 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 have ever had an allergic reaction to any other pain reliever/fever reducer • for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor 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 help 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 for more than 10 days • fever gets worse or lasts for more than 3 days • redness or swelling is present • new symptoms occur • ringing in the ears or loss of hearing occurs These could be signs of a serious condition If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in 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 (1-80...

Additional Listing Data#

Finished product
Yes
Brand name base
aspirin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN81 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR16CO5Y76E
Rxcui318272

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
0904-4040-73aspirin1 in 1 CARTONTABLET, CHEWABLE16
0904-4040-73aspirin36 in 1 BOTTLETABLET, CHEWABLE366

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-4040-73EA - Each0904-4040bb5cc8ec-5b24-4182-ad88-2e3f6251767912012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-4040ASPIRIN TABLET, CHEWABLE [MAJOR PHARMACEUTICALS]6Current NDC, Legacy NDC, 2 package rows20240915_58684138-04d1-44a4-bc52-c5b85d93d7a6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
318272aspirin 81 MG Chewable TabletPSN65c41c20-2f9c-4012-900b-c2ffdf66514410
318272aspirin 81 MG Chewable TabletSCD65c41c20-2f9c-4012-900b-c2ffdf66514410
318272ASA 81 MG Chewable TabletSY65c41c20-2f9c-4012-900b-c2ffdf66514410
318272aspirin 81 MG Chewable TabletPSN58684138-04d1-44a4-bc52-c5b85d93d7a66
318272aspirin 81 MG Chewable TabletSCD58684138-04d1-44a4-bc52-c5b85d93d7a66
318272ASA 81 MG Chewable TabletSY58684138-04d1-44a4-bc52-c5b85d93d7a66
318272aspirin 81 MG Chewable TabletPSN3c7783a7-2b28-4968-b766-0a49dc70ce6d5
318272aspirin 81 MG Chewable TabletSCD3c7783a7-2b28-4968-b766-0a49dc70ce6d5
318272ASA 81 MG Chewable TabletSY3c7783a7-2b28-4968-b766-0a49dc70ce6d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-4040-73009044040731 BOTTLE in 1 CARTON (0904-4040-73) / 36 TABLET, CHEWABLE in 1 BOTTLE1 bottle2007-12-120000-00-00NoNoCurrent