Aspirin

Product NDC
0363-6450
11-digit product format
003636450
Labeler code
0363
Product ID
0363-6450_d5928f5a-b76a-4f18-836e-63c3a3089405
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Walgreen Company
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-07-25
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

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 packagepackage0363-64500363-6450-07DDiscontinued by firm2026-07-31
excluded packagepackage0363-64500363-6450-12DDiscontinued by firm2026-07-31
excluded packagepackage0363-64500363-6450-32DDiscontinued by firm2026-07-31
excluded packagepackage0363-64500363-6450-60DDiscontinued 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
Aspirin Enteric Coated Low DoseASPIRINWalgreen Companyb11a4c4e-374c-403e-a757-5e9700f9f03b2025-08-27WarningsExact 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 shock asthma (wheezing) Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you take more or for a longer time than directed take a blood thinning (anticoagulant) or steroid drug have had stomach ulcers or bleeding problems have 3 or more alcoholic drinks every day while using this product are age 60 or older take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] 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 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 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: have bloody or black stools feel faint vomit blood 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 fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur 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
Brand name suffix
Enteric Coated Low Dose
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN81 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR16CO5Y76E
Rxcui308416

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
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
0363-6450-07AspirinEnteric Coated Low Dose1 in 1 CARTONTABLET, DELAYED RELEASE120
0363-6450-07AspirinEnteric Coated Low Dose36 in 1 BOTTLETABLET, DELAYED RELEASE3620
0363-6450-12AspirinEnteric Coated Low Dose100 in 1 BOTTLETABLET, DELAYED RELEASE10020
0363-6450-12AspirinEnteric Coated Low Dose1 in 1 CARTONTABLET, DELAYED RELEASE120
0363-6450-14AspirinEnteric Coated Low Dose500 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE50020
0363-6450-32AspirinEnteric Coated Low Dose120 in 1 BOTTLETABLET, DELAYED RELEASE12020
0363-6450-32AspirinEnteric Coated Low Dose1 in 1 CARTONTABLET, DELAYED RELEASE120
0363-6450-60AspirinEnteric Coated Low Dose1 in 1 CARTONTABLET, DELAYED RELEASE120
0363-6450-60AspirinEnteric Coated Low Dose180 in 1 BOTTLETABLET, DELAYED RELEASE18020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-6450-14EA - Each0363-6450be9c8fbb-0404-4607-b85e-23a09341855112019-03-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76EASPIRIN ENTERIC COATED LOW DOSE (ASPIRIN) TABLET, COATED [WALGREEN CO.]3
ASPIRINACTIVE MOIETYR16CO5Y76EASPIRIN ENTERIC COATED LOW DOSE (ASPIRIN) TABLET, COATED [WALGREEN CO.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UASPIRIN ENTERIC COATED LOW DOSE (ASPIRIN) TABLET, COATED [WALGREEN CO.]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAASPIRIN ENTERIC COATED LOW DOSE (ASPIRIN) TABLET, COATED [WALGREEN CO.]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ASPIRIN ENTERIC COATED LOW DOSE (ASPIRIN) TABLET, COATED [WALGREEN CO.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOASPIRIN ENTERIC COATED LOW DOSE (ASPIRIN) TABLET, COATED [WALGREEN CO.]3
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656ASPIRIN ENTERIC COATED LOW DOSE (ASPIRIN) TABLET, COATED [WALGREEN CO.]3
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEASPIRIN ENTERIC COATED LOW DOSE (ASPIRIN) TABLET, COATED [WALGREEN CO.]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AASPIRIN ENTERIC COATED LOW DOSE (ASPIRIN) TABLET, COATED [WALGREEN CO.]3
SHELLACINACTIVE INGREDIENT46N107B71OASPIRIN ENTERIC COATED LOW DOSE (ASPIRIN) TABLET, COATED [WALGREEN CO.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ASPIRIN ENTERIC COATED LOW DOSE (ASPIRIN) TABLET, COATED [WALGREEN CO.]3
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOASPIRIN ENTERIC COATED LOW DOSE (ASPIRIN) TABLET, COATED [WALGREEN CO.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JASPIRIN ENTERIC COATED LOW DOSE (ASPIRIN) TABLET, COATED [WALGREEN CO.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJASPIRIN ENTERIC COATED LOW DOSE (ASPIRIN) TABLET, COATED [WALGREEN CO.]3
TALCINACTIVE INGREDIENT7SEV7J4R1UASPIRIN ENTERIC COATED LOW DOSE (ASPIRIN) TABLET, COATED [WALGREEN CO.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPASPIRIN ENTERIC COATED LOW DOSE (ASPIRIN) TABLET, COATED [WALGREEN CO.]3
TRIACETININACTIVE INGREDIENTXHX3C3X673ASPIRIN ENTERIC COATED LOW DOSE (ASPIRIN) TABLET, COATED [WALGREEN CO.]3
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMASPIRIN ENTERIC COATED LOW DOSE (ASPIRIN) TABLET, COATED [WALGREEN CO.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-6450ASPIRIN ENTERIC COATED LOW DOSE (ASPIRIN) TABLET, DELAYED RELEASE [WALGREEN COMPANY]19Current NDC, Legacy NDC, 9 package rows20240829_b11a4c4e-374c-403e-a757-5e9700f9f03b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSNb11a4c4e-374c-403e-a757-5e9700f9f03b20
308416aspirin 81 MG Delayed Release Oral TabletSCDb11a4c4e-374c-403e-a757-5e9700f9f03b20
308416ASA 81 MG Delayed Release Oral TabletSYb11a4c4e-374c-403e-a757-5e9700f9f03b20
308416aspirin 81 MG Enteric Coated Oral TabletSYb11a4c4e-374c-403e-a757-5e9700f9f03b20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-6450-07003636450071 in 1 CARTONHistorical
0363-6450-1200363645012100 in 1 BOTTLEHistorical
0363-6450-1400363645014500 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0363-6450-14) 2014-07-250000-00-00NoNoCurrent
0363-6450-32003636450321 BOTTLE in 1 CARTON (0363-6450-32) > 120 TABLET, COATED in 1 BOTTLE1 bottle2014-07-252023-04-22NoNoCurrent
0363-6450-60003636450601 BOTTLE in 1 CARTON (0363-6450-60) > 180 TABLET, COATED in 1 BOTTLE1 bottle2014-07-252022-04-27NoNoCurrent