FDA.reportPublic FDA data

Aspirin

Product NDC
0363-0563
11-digit product format
003630563
Labeler code
0363
Product ID
0363-0563_5ebfb61b-08ed-49ca-b88a-c58e61a96ab1
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
2011-05-01
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Aspirin
Brand name suffix
enteric coated low dose
Listing expiration
2027-12-31

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
0363-0563-06Aspirinenteric coated low dose200 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE20022
0363-0563-06Aspirinenteric coated low dose1 in 1 CARTONTABLET, DELAYED RELEASE122
0363-0563-14Aspirinenteric coated low dose500 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE50022
0363-0563-17Aspirinenteric coated low dose1 in 1 CARTONTABLET, DELAYED RELEASE122
0363-0563-17Aspirinenteric coated low dose300 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE30022
0363-0563-22Aspirinenteric coated low dose1 in 1 CARTONTABLET, DELAYED RELEASE122
0363-0563-22Aspirinenteric coated low dose48 in 1 BOTTLETABLET, DELAYED RELEASE4822
0363-0563-27Aspirinenteric coated low dose32 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE3222
0363-0563-27Aspirinenteric coated low dose1 in 1 CARTONTABLET, DELAYED RELEASE122
0363-0563-32Aspirinenteric coated low dose120 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE12022
0363-0563-32Aspirinenteric coated low dose1 in 1 CARTONTABLET, DELAYED RELEASE122
0363-0563-62Aspirinenteric coated low dose15 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE1522
0363-0563-62Aspirinenteric coated low dose1 in 1 CARTONTABLET, DELAYED RELEASE122
0363-0563-63Aspirinenteric coated low dose2 in 1 CARTONTABLET, DELAYED RELEASE222
0363-0563-63Aspirinenteric coated low dose120 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE12022
0363-0563-90Aspirinenteric coated low dose150 in 1 BOTTLETABLET, DELAYED RELEASE15022
0363-0563-90Aspirinenteric coated low dose1 in 1 CARTONTABLET, DELAYED RELEASE122

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0563-14EA - Each0363-0563b53d7133-8ebc-4bf9-894f-bf03cf1b220d12016-04-04
0363-0563-17EA - Each0363-056362c5b1dc-ef6f-40f7-8fa4-5404c1a6d48312013-05-02
0363-0563-22EA - Each0363-05635a2036ed-798a-49bc-a3e7-e8df52aa0c3f12016-04-04
0363-0563-27EA - Each0363-0563cc0d1e94-9b36-40ce-a397-9cd3548e7d8b12024-07-12
0363-0563-29EA - Each0363-05633ed391bb-6b7b-40dd-bf39-05c307b5d94b12013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76EENTERIC COATED LOW DOSE ASPIRIN (ASPIRIN) TABLET, COATED [WALGREEN CO.]5
ASPIRINACTIVE MOIETYR16CO5Y76EENTERIC COATED LOW DOSE ASPIRIN (ASPIRIN) TABLET, COATED [WALGREEN CO.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UENTERIC COATED LOW DOSE ASPIRIN (ASPIRIN) TABLET, COATED [WALGREEN CO.]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GENTERIC COATED LOW DOSE ASPIRIN (ASPIRIN) TABLET, COATED [WALGREEN CO.]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOENTERIC COATED LOW DOSE ASPIRIN (ASPIRIN) TABLET, COATED [WALGREEN CO.]5
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656ENTERIC COATED LOW DOSE ASPIRIN (ASPIRIN) TABLET, COATED [WALGREEN CO.]5
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEENTERIC COATED LOW DOSE ASPIRIN (ASPIRIN) TABLET, COATED [WALGREEN CO.]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AENTERIC COATED LOW DOSE ASPIRIN (ASPIRIN) TABLET, COATED [WALGREEN CO.]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ENTERIC COATED LOW DOSE ASPIRIN (ASPIRIN) TABLET, COATED [WALGREEN CO.]5
SHELLACINACTIVE INGREDIENT46N107B71OENTERIC COATED LOW DOSE ASPIRIN (ASPIRIN) TABLET, COATED [WALGREEN CO.]5
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOENTERIC COATED LOW DOSE ASPIRIN (ASPIRIN) TABLET, COATED [WALGREEN CO.]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JENTERIC COATED LOW DOSE ASPIRIN (ASPIRIN) TABLET, COATED [WALGREEN CO.]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJENTERIC COATED LOW DOSE ASPIRIN (ASPIRIN) TABLET, COATED [WALGREEN CO.]5
TALCINACTIVE INGREDIENT7SEV7J4R1UENTERIC COATED LOW DOSE ASPIRIN (ASPIRIN) TABLET, COATED [WALGREEN CO.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPENTERIC COATED LOW DOSE ASPIRIN (ASPIRIN) TABLET, COATED [WALGREEN CO.]5
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMENTERIC COATED LOW DOSE ASPIRIN (ASPIRIN) TABLET, COATED [WALGREEN CO.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0563ASPIRIN ENTERIC COATED LOW DOSE (ASPIRIN) TABLET, DELAYED RELEASE [WALGREEN COMPANY]21Current NDC, Legacy NDC, 17 package rows20250116_186a6270-e3de-4499-88a4-5f723fee3e34.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSN186a6270-e3de-4499-88a4-5f723fee3e3422
308416aspirin 81 MG Delayed Release Oral TabletSCD186a6270-e3de-4499-88a4-5f723fee3e3422
308416ASA 81 MG Delayed Release Oral TabletSY186a6270-e3de-4499-88a4-5f723fee3e3422
308416aspirin 81 MG Enteric Coated Oral TabletSY186a6270-e3de-4499-88a4-5f723fee3e3422

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0563-06003630563061 BOTTLE, PLASTIC in 1 CARTON (0363-0563-06) / 200 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC2011-05-010000-00-00NoNoCurrent
0363-0563-1400363056314500 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0363-0563-14) 2011-05-010000-00-00NoNoCurrent
0363-0563-17003630563171 BOTTLE, PLASTIC in 1 CARTON (0363-0563-17) / 300 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC2011-05-010000-00-00NoNoCurrent
0363-0563-22003630563221 BOTTLE in 1 CARTON (0363-0563-22) > 48 TABLET, COATED in 1 BOTTLE1 bottle2011-05-012021-08-14NoNoCurrent
0363-0563-27003630563271 BOTTLE, PLASTIC in 1 CARTON (0363-0563-27) / 32 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC2011-05-010000-00-00NoNoCurrent
0363-0563-32003630563321 BOTTLE, PLASTIC in 1 CARTON (0363-0563-32) / 120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC2011-05-010000-00-00NoNoCurrent
0363-0563-620036305636215 in 1 BOTTLE, PLASTICHistorical
0363-0563-63003630563632 BOTTLE, PLASTIC in 1 CARTON (0363-0563-63) / 120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC2011-05-010000-00-00NoNoCurrent
0363-0563-90003630563901 BOTTLE in 1 CARTON (0363-0563-90) > 150 TABLET, COATED in 1 BOTTLE1 bottle2011-05-010000-00-00NoNoCurrent