FDA.reportPublic FDA data

Pain Reliever

Product NDC
68210-4177
11-digit product format
682104177
Labeler code
68210
Product ID
68210-4177_ef1965c7-3827-0ddc-e053-2995a90a5968
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Spirit Pharmaceuticals LLC
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-11-22
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68210-4177IInactivated by FDA2026-10-16
excluded packagepackage68210-417768210-4177-1IInactivated by FDA2026-10-16

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
68210-4177-1Pain Reliever120 in 1 POUCHTABLET, COATED1205

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-4177PAIN RELIEVER (ASPIRIN) TABLET, COATED [SPIRIT PHARMACEUTICALS LLC]5Legacy NDC, 1 package rows20241215_9ed78f4c-150f-4be3-8942-da30a936b59a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSN9ed78f4c-150f-4be3-8942-da30a936b59a5
308416aspirin 81 MG Delayed Release Oral TabletSCD9ed78f4c-150f-4be3-8942-da30a936b59a5
308416ASA 81 MG Delayed Release Oral TabletSY9ed78f4c-150f-4be3-8942-da30a936b59a5
308416aspirin 81 MG Enteric Coated Oral TabletSY9ed78f4c-150f-4be3-8942-da30a936b59a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68210-4177-168210417701120 TABLET, COATED in 1 POUCH (68210-4177-1) 2021-11-220000-00-00NoNoCurrent