Aspirin

Product NDC
36800-157
11-digit product format
368000157
Labeler code
36800
Product ID
36800-157_0c7347e3-ceff-4b00-9ddb-9e0e70b6f161
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Topco Associates, LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1996-02-10
Substance
ASPIRIN
Active strength
325 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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage36800-15736800-157-87DDiscontinued by firm2026-07-31

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
AspirinASPIRINTopco Associates, LLC5f32cf74-dbea-496c-ba23-2040ea354f402026-06-25WarningsExact 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 shock facial swelling asthma (wheezing) Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you take a blood thinning (anticoagulant) or steroid drug have had stomach ulcers or bleeding problems take more or for a longer time than directed 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 are age 60 or older Do not use if you are allergic to aspirin or any other pain reliever/fever reducer if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if stomach bleeding warning applies to you you have asthma you have a history of stomach problems, such as heartburn you are taking a diuretic you have high blood pressure, heart disease, liver cirrhosis, or kidney disease 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 ringing in the ears or a loss of hearing occurs pain gets worse or lasts more than 10 days new symptoms occur fever gets worse or lasts more than 3 days redness or swelling is present 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.

Additional Listing Data#

Finished product
Yes
Brand name base
Aspirin
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN325 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR16CO5Y76E
Rxcui212033

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
36800-157-12Aspirin100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10012
36800-157-14Aspirin500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50012
36800-157-17Aspirin300 in 1 BOTTLE, PLASTICTABLET, FILM COATED30012
36800-157-87Aspirin1 in 1 CARTONTABLET, FILM COATED112
36800-157-87Aspirin100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-157-12EA - Each36800-1570f0db46a-96c9-4821-bebe-b9e6a649555312024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-157ASPIRIN TABLET, FILM COATED [TOPCO ASSOCIATES, LLC]11Current NDC, Legacy NDC, 5 package rows20240615_5f32cf74-dbea-496c-ba23-2040ea354f40.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
212033aspirin 325 MG Oral TabletPSN5f32cf74-dbea-496c-ba23-2040ea354f4012
212033aspirin 325 MG Oral TabletSCD5f32cf74-dbea-496c-ba23-2040ea354f4012
212033ASA 325 MG Oral TabletSY5f32cf74-dbea-496c-ba23-2040ea354f4012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
36800-157-1236800015712100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (36800-157-12) 1996-02-100000-00-00NoNoCurrent
36800-157-1436800015714500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (36800-157-14) 1996-02-100000-00-00NoNoCurrent
36800-157-1736800015717300 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (36800-157-17) 1996-02-100000-00-00NoNoCurrent
36800-157-87368000157871 BOTTLE, PLASTIC in 1 CARTON (36800-157-87) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1996-02-102026-06-13NoNoCurrent