Aspirin 81 mg

Product NDC
55681-402
Requested package NDC
55681-402-03
11-digit product format
556810402
Labeler code
55681
Product ID
55681-402_f0398170-c8fd-4dcc-e053-2995a90a1c93
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin Enteric Coated Tablets 81 mg
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
TWIN MED LLC
Application
part343
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-11-01
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 packagepackage55681-40255681-402-03DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55681-402ASPIRIN 81 MG (ASPIRIN ENTERIC COATED TABLETS 81 MG) TABLET, DELAYED RELEASE [TWIN MED LLC]5Legacy NDC20240119_f0390eef-22d9-134d-e053-2a95a90aa420.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55681-402-0355681040203300 TABLET, DELAYED RELEASE in 1 BOTTLE (55681-402-03) 2022-11-010000-00-00NoNoCurrent