FDA.reportPublic FDA data

ASPIRIN

Product NDC
68210-4128
Requested package NDC
68210-4128-4
11-digit product format
682104128
Labeler code
68210
Product ID
68210-4128_ee8bb5f4-4491-3376-e053-2a95a90a2523
Type
HUMAN OTC DRUG
Nonproprietary name
ASPIRIN
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
SPIRIT PHARMACEUTICALS LLC
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-04-27
Marketing end
0000-00-00
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
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68210-412868210-4128-4IInactivated by FDA2026-10-05

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
68210-4128-4ASPIRIN40 in 1 BOTTLETABLET, DELAYED RELEASE406
68210-4128-4ASPIRIN1 in 1 CARTONTABLET, DELAYED RELEASE16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-4128ASPIRIN TABLET, DELAYED RELEASE [SPIRIT PHARMACEUTICALS LLC]6Legacy NDC, 2 package rows20241211_c0fb38f5-79bb-7460-e053-2995a90a1667.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSNc0fb38f5-79bb-7460-e053-2995a90a16676
308416aspirin 81 MG Delayed Release Oral TabletSCDc0fb38f5-79bb-7460-e053-2995a90a16676
308416ASA 81 MG Delayed Release Oral TabletSYc0fb38f5-79bb-7460-e053-2995a90a16676
308416aspirin 81 MG Enteric Coated Oral TabletSYc0fb38f5-79bb-7460-e053-2995a90a16676

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68210-4128-4682104128041 BOTTLE in 1 CARTON (68210-4128-4) > 40 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2021-04-270000-00-00NoNoCurrent