FDA.reportPublic FDA data

Aspirin

Product NDC
63981-563
11-digit product format
639810563
Labeler code
63981
Product ID
63981-563_926a6f8d-a449-4f89-9bee-3bc6fad45ff6
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
COSTCO WHOLESALE CORPORATION
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
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
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
63981-563-51AspirinLow Dose365 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE36519
63981-563-51AspirinLow Dose2 in 1 CARTONTABLET, DELAYED RELEASE219
63981-563-62AspirinLow Dose15 in 1 BOTTLETABLET, DELAYED RELEASE1519
63981-563-62AspirinLow Dose1 in 1 PACKAGETABLET, DELAYED RELEASE119
63981-563-96AspirinLow Dose365 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE36519
63981-563-96AspirinLow Dose2 in 1 PACKAGETABLET, DELAYED RELEASE219

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63981-563-51EA - Each63981-563d9c8425b-6e9e-4ff1-b27e-98ac872c425b12012-07-24
63981-563-96EA - Each63981-56382220c7d-9c14-412d-a9a1-699d8ac2708212019-12-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76EASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [COSTCO WHOLESALE CORPORATION]2
ASPIRINACTIVE MOIETYR16CO5Y76EASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [COSTCO WHOLESALE CORPORATION]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [COSTCO WHOLESALE CORPORATION]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [COSTCO WHOLESALE CORPORATION]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [COSTCO WHOLESALE CORPORATION]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [COSTCO WHOLESALE CORPORATION]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [COSTCO WHOLESALE CORPORATION]2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [COSTCO WHOLESALE CORPORATION]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [COSTCO WHOLESALE CORPORATION]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [COSTCO WHOLESALE CORPORATION]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [COSTCO WHOLESALE CORPORATION]2
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [COSTCO WHOLESALE CORPORATION]2
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [COSTCO WHOLESALE CORPORATION]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [COSTCO WHOLESALE CORPORATION]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [COSTCO WHOLESALE CORPORATION]2
TALCINACTIVE INGREDIENT7SEV7J4R1UASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [COSTCO WHOLESALE CORPORATION]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [COSTCO WHOLESALE CORPORATION]2
TRIACETININACTIVE INGREDIENTXHX3C3X673ASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [COSTCO WHOLESALE CORPORATION]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMASPIRIN LOW DOSE (ASPIRIN) TABLET, COATED [COSTCO WHOLESALE CORPORATION]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63981-563ASPIRIN LOW DOSE (ASPIRIN) TABLET, DELAYED RELEASE [COSTCO WHOLESALE CORPORATION]18Current NDC, Legacy NDC, 6 package rows20250502_c8a8986b-1ab4-9da0-71da-42595db08b44.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSNc8a8986b-1ab4-9da0-71da-42595db08b4419
308416aspirin 81 MG Delayed Release Oral TabletSCDc8a8986b-1ab4-9da0-71da-42595db08b4419
308416ASA 81 MG Delayed Release Oral TabletSYc8a8986b-1ab4-9da0-71da-42595db08b4419
308416aspirin 81 MG Enteric Coated Oral TabletSYc8a8986b-1ab4-9da0-71da-42595db08b4419

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63981-563-51639810563512 BOTTLE, PLASTIC in 1 CARTON (63981-563-51) > 365 TABLET, COATED in 1 BOTTLE, PLASTIC2011-05-012021-05-28NoNoCurrent
63981-563-62639810563621 BOTTLE in 1 PACKAGE (63981-563-62) > 15 TABLET, COATED in 1 BOTTLE1 bottle2011-05-010000-00-00YesNoCurrent
63981-563-96639810563962 BOTTLE, PLASTIC in 1 PACKAGE (63981-563-96) / 365 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC2011-05-010000-00-00NoNoCurrent