FDA.reportPublic FDA data

Aspirin

Product NDC
63868-363
11-digit product format
638680363
Labeler code
63868
Product ID
63868-363_ec1fb7bc-b213-45e3-841e-9ad575e5b810
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
CHAIN DRUG MARKETING ASSOCIATION INC
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Aspirin
Brand name suffix
Enteric Coated
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
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
63868-363-20AspirinEnteric Coated1 in 1 CARTONTABLET, DELAYED RELEASE119
63868-363-20AspirinEnteric Coated120 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE12019
63868-363-36AspirinEnteric Coated365 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE36519

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-363-20EA - Each63868-363cd1a469f-cbc9-4cba-ae87-72fe5b20d80612017-04-05
63868-363-36EA - Each63868-363559adcf4-7784-4e46-be33-d87c277cc16d12019-03-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76EASPIRIN ENTERIC COATED (ASPIRIN) TABLET, DELAYED RELEASE [CHAIN DRUG MARKETING ASSOCIATION INC]5
ASPIRINACTIVE MOIETYR16CO5Y76EASPIRIN ENTERIC COATED (ASPIRIN) TABLET, DELAYED RELEASE [CHAIN DRUG MARKETING ASSOCIATION INC]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UASPIRIN ENTERIC COATED (ASPIRIN) TABLET, DELAYED RELEASE [CHAIN DRUG MARKETING ASSOCIATION INC]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GASPIRIN ENTERIC COATED (ASPIRIN) TABLET, DELAYED RELEASE [CHAIN DRUG MARKETING ASSOCIATION INC]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ASPIRIN ENTERIC COATED (ASPIRIN) TABLET, DELAYED RELEASE [CHAIN DRUG MARKETING ASSOCIATION INC]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOASPIRIN ENTERIC COATED (ASPIRIN) TABLET, DELAYED RELEASE [CHAIN DRUG MARKETING ASSOCIATION INC]5
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656ASPIRIN ENTERIC COATED (ASPIRIN) TABLET, DELAYED RELEASE [CHAIN DRUG MARKETING ASSOCIATION INC]5
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEASPIRIN ENTERIC COATED (ASPIRIN) TABLET, DELAYED RELEASE [CHAIN DRUG MARKETING ASSOCIATION INC]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AASPIRIN ENTERIC COATED (ASPIRIN) TABLET, DELAYED RELEASE [CHAIN DRUG MARKETING ASSOCIATION INC]5
SHELLACINACTIVE INGREDIENT46N107B71OASPIRIN ENTERIC COATED (ASPIRIN) TABLET, DELAYED RELEASE [CHAIN DRUG MARKETING ASSOCIATION INC]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ASPIRIN ENTERIC COATED (ASPIRIN) TABLET, DELAYED RELEASE [CHAIN DRUG MARKETING ASSOCIATION INC]5
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOASPIRIN ENTERIC COATED (ASPIRIN) TABLET, DELAYED RELEASE [CHAIN DRUG MARKETING ASSOCIATION INC]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JASPIRIN ENTERIC COATED (ASPIRIN) TABLET, DELAYED RELEASE [CHAIN DRUG MARKETING ASSOCIATION INC]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJASPIRIN ENTERIC COATED (ASPIRIN) TABLET, DELAYED RELEASE [CHAIN DRUG MARKETING ASSOCIATION INC]5
TALCINACTIVE INGREDIENT7SEV7J4R1UASPIRIN ENTERIC COATED (ASPIRIN) TABLET, DELAYED RELEASE [CHAIN DRUG MARKETING ASSOCIATION INC]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPASPIRIN ENTERIC COATED (ASPIRIN) TABLET, DELAYED RELEASE [CHAIN DRUG MARKETING ASSOCIATION INC]5
TRIACETININACTIVE INGREDIENTXHX3C3X673ASPIRIN ENTERIC COATED (ASPIRIN) TABLET, DELAYED RELEASE [CHAIN DRUG MARKETING ASSOCIATION INC]5
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMASPIRIN ENTERIC COATED (ASPIRIN) TABLET, DELAYED RELEASE [CHAIN DRUG MARKETING ASSOCIATION INC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-363ASPIRIN ENTERIC COATED (ASPIRIN) TABLET, DELAYED RELEASE [CHAIN DRUG MARKETING ASSOCIATION INC]18Current NDC, Legacy NDC, 3 package rows20250502_f1ce15a3-9824-4eb5-910a-39078165f385.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSNf1ce15a3-9824-4eb5-910a-39078165f38519
308416aspirin 81 MG Delayed Release Oral TabletSCDf1ce15a3-9824-4eb5-910a-39078165f38519
308416ASA 81 MG Delayed Release Oral TabletSYf1ce15a3-9824-4eb5-910a-39078165f38519
308416aspirin 81 MG Enteric Coated Oral TabletSYf1ce15a3-9824-4eb5-910a-39078165f38519

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63868-363-20638680363201 BOTTLE, PLASTIC in 1 CARTON (63868-363-20) / 120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC2011-05-012027-12-31NoNoCurrent
63868-363-3663868036336365 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (63868-363-36) 2011-05-010000-00-00NoNoCurrent