Home NDC 80513-289 Adult Low Dose Aspirin
Product NDC 80513-289
11-digit product format 805130289
Labeler code 80513
Product ID 80513-289_38ec4680-85ec-6450-e063-6294a90aeb69
Type HUMAN OTC DRUG
Nonproprietary name Aspirin
Dosage form TABLET, DELAYED RELEASE
Route ORAL
Labeler Advanced Rx LLC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-12-01
Marketing end 2028-06-30
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
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Adult Low Dose Aspirin Active Ingredients# Ingredient, Strength table Ingredient Strength ASPIRIN 81 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination R16CO5Y76E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 308416 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 80513-289-03 Adult Low Dose Aspirin 300 in 1 BOTTLE TABLET, DELAYED RELEASE 300 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80513-289 ADULT LOW DOSE ASPIRIN (ASPIRIN) TABLET, DELAYED RELEASE [ADVANCED RX LLC] 1 Current NDC, 1 package rows 20250110_ad0d6a5c-eee9-406c-8d7f-1df9b45f5340.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 83 · 1,657 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 80513-289-03 80513028903 300 TABLET, DELAYED RELEASE in 1 BOTTLE (80513-289-03) 2024-12-01 2028-06-30 No No Historical