FDA.reportPublic FDA data

Aspirin

Product NDC
63868-469
11-digit product format
638680469
Labeler code
63868
Product ID
63868-469_284aea17-a286-78fa-e063-6394a90a46bd
Type
HUMAN OTC DRUG
Nonproprietary name
ASPIRIN
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Chain Drug Marketing Association
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-09-26
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
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
63868-469-36Aspirin36 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE364
63868-469-36Aspirin1 in 1 CARTONTABLET, DELAYED RELEASE14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-469-36EA - Each63868-469b5b3e67e-2fc6-4040-a5f5-a4290af3aa2b12022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-469ASPIRIN TABLET, DELAYED RELEASE [CHAIN DRUG MARKETING ASSOCIATION]4Current NDC, Legacy NDC, 2 package rows20241204_0e3be5f4-bc1b-4b44-a86a-ace89f6ee592.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSN0e3be5f4-bc1b-4b44-a86a-ace89f6ee5924
308416aspirin 81 MG Delayed Release Oral TabletSCD0e3be5f4-bc1b-4b44-a86a-ace89f6ee5924
308416ASA 81 MG Delayed Release Oral TabletSY0e3be5f4-bc1b-4b44-a86a-ace89f6ee5924
308416aspirin 81 MG Enteric Coated Oral TabletSY0e3be5f4-bc1b-4b44-a86a-ace89f6ee5924

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63868-469-36638680469361 BOTTLE, PLASTIC in 1 CARTON (63868-469-36) / 36 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC2018-09-260000-00-00NoNoCurrent