FDA.reportPublic FDA data

Aspirin

Product NDC
0363-0227
11-digit product format
003630227
Labeler code
0363
Product ID
0363-0227_dc59a437-ff45-4022-a5da-41f415cd00a4
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
1992-12-14
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

Additional Listing Data#

Finished product
Yes
Brand name base
Aspirin
Brand name suffix
Enteric Coated, Regular Strength
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN325 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR16CO5Y76E
Rxcui198467

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
0363-0227-14AspirinEnteric Coated, Regular Strength500 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE50019
0363-0227-57AspirinEnteric Coated, Regular Strength1 in 1 CARTONTABLET, DELAYED RELEASE119
0363-0227-57AspirinEnteric Coated, Regular Strength125 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE12519

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0227-14EA - Each0363-0227fa72a133-c1fc-4231-8631-aa967e063ad212013-02-13
0363-0227-57EA - Each0363-0227ae54bf10-25c0-43d0-9794-34c9d00ffb7312013-06-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76EASPIRIN ENTERIC COATED, REGULAR STRENGTH (ASPIRIN) TABLET, COATED [WALGREEN CO.]4
ASPIRINACTIVE MOIETYR16CO5Y76EASPIRIN ENTERIC COATED, REGULAR STRENGTH (ASPIRIN) TABLET, COATED [WALGREEN CO.]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GASPIRIN ENTERIC COATED, REGULAR STRENGTH (ASPIRIN) TABLET, COATED [WALGREEN CO.]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ASPIRIN ENTERIC COATED, REGULAR STRENGTH (ASPIRIN) TABLET, COATED [WALGREEN CO.]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ASPIRIN ENTERIC COATED, REGULAR STRENGTH (ASPIRIN) TABLET, COATED [WALGREEN CO.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOASPIRIN ENTERIC COATED, REGULAR STRENGTH (ASPIRIN) TABLET, COATED [WALGREEN CO.]4
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEASPIRIN ENTERIC COATED, REGULAR STRENGTH (ASPIRIN) TABLET, COATED [WALGREEN CO.]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AASPIRIN ENTERIC COATED, REGULAR STRENGTH (ASPIRIN) TABLET, COATED [WALGREEN CO.]4
Polyvinyl Acetate PhthalateINACTIVE INGREDIENT58QVG85GW3ASPIRIN ENTERIC COATED, REGULAR STRENGTH (ASPIRIN) TABLET, COATED [WALGREEN CO.]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ASPIRIN ENTERIC COATED, REGULAR STRENGTH (ASPIRIN) TABLET, COATED [WALGREEN CO.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ASPIRIN ENTERIC COATED, REGULAR STRENGTH (ASPIRIN) TABLET, COATED [WALGREEN CO.]4
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQASPIRIN ENTERIC COATED, REGULAR STRENGTH (ASPIRIN) TABLET, COATED [WALGREEN CO.]4
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOASPIRIN ENTERIC COATED, REGULAR STRENGTH (ASPIRIN) TABLET, COATED [WALGREEN CO.]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APASPIRIN ENTERIC COATED, REGULAR STRENGTH (ASPIRIN) TABLET, COATED [WALGREEN CO.]4
TALCINACTIVE INGREDIENT7SEV7J4R1UASPIRIN ENTERIC COATED, REGULAR STRENGTH (ASPIRIN) TABLET, COATED [WALGREEN CO.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPASPIRIN ENTERIC COATED, REGULAR STRENGTH (ASPIRIN) TABLET, COATED [WALGREEN CO.]4
TRIACETININACTIVE INGREDIENTXHX3C3X673ASPIRIN ENTERIC COATED, REGULAR STRENGTH (ASPIRIN) TABLET, COATED [WALGREEN CO.]4
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMASPIRIN ENTERIC COATED, REGULAR STRENGTH (ASPIRIN) TABLET, COATED [WALGREEN CO.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0227ASPIRIN ENTERIC COATED, REGULAR STRENGTH (ASPIRIN) TABLET, DELAYED RELEASE [WALGREEN COMPANY]17Current NDC, Legacy NDC, 3 package rows20240825_5e1484d3-5be1-40da-a3bf-fb19f7d27d45.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198467aspirin 325 MG Delayed Release Oral TabletPSN5e1484d3-5be1-40da-a3bf-fb19f7d27d4519
198467aspirin 325 MG Delayed Release Oral TabletSCD5e1484d3-5be1-40da-a3bf-fb19f7d27d4519
198467ASA 325 MG Delayed Release Oral TabletSY5e1484d3-5be1-40da-a3bf-fb19f7d27d4519
198467aspirin 325 MG Enteric Coated Oral TabletSY5e1484d3-5be1-40da-a3bf-fb19f7d27d4519

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-0227-1400363022714500 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (0363-0227-14) 1992-12-140000-00-00NoNoCurrent
0363-0227-57003630227571 in 1 CARTONHistorical