FDA.reportPublic FDA data

Aspirin

Product NDC
63868-352
11-digit product format
638680352
Labeler code
63868
Product ID
63868-352_67d8f977-d0de-4f94-a6b7-1fb6e27f01df
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
CHAIN DRUG MARKETING ASSOCIATION INC
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
1996-02-10
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63868-352DDiscontinued by firm2026-10-16
excluded packagepackage63868-35263868-352-03DDiscontinued by firm2026-10-16
excluded packagepackage63868-35263868-352-10DDiscontinued by firm2026-10-16

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
63868-352-03Aspirin300 in 1 BOTTLETABLET, FILM COATED30017
63868-352-10Aspirin100 in 1 BOTTLETABLET, FILM COATED10017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-352-03EA - Each63868-352e2a22685-9985-4615-a889-63cb31d4cb9212014-07-02
63868-352-10EA - Each63868-3527cce773e-54b9-42c7-8f8e-9ffb335d11aa12014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76EASPIRIN TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]5
ASPIRINACTIVE MOIETYR16CO5Y76EASPIRIN TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOASPIRIN TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AASPIRIN TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ASPIRIN TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJASPIRIN TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-352ASPIRIN TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]16Legacy NDC, 2 package rows20241121_ea4cf2d5-477c-4c3f-b50c-f695a9b38be8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
212033aspirin 325 MG Oral TabletPSNea4cf2d5-477c-4c3f-b50c-f695a9b38be817
212033aspirin 325 MG Oral TabletSCDea4cf2d5-477c-4c3f-b50c-f695a9b38be817
212033ASA 325 MG Oral TabletSYea4cf2d5-477c-4c3f-b50c-f695a9b38be817

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63868-352-0363868035203300 TABLET, FILM COATED in 1 BOTTLE (63868-352-03) 1996-02-100000-00-00NoNoCurrent
63868-352-1063868035210100 TABLET, FILM COATED in 1 BOTTLE (63868-352-10) 1996-02-100000-00-00NoNoCurrent