FDA.reportPublic FDA data

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

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