Home NDC 0615-8613 Adult Low Dose Aspirin
Product NDC 0615-8613
11-digit product format 006158613
Labeler code 0615
Product ID 0615-8613_b4d7ffaf-5325-4a54-a11d-b1cef2faeb94
Type HUMAN OTC DRUG
Nonproprietary name Aspirin
Dosage form TABLET, DELAYED RELEASE
Route ORAL
Labeler NCS HealthCare of KY, LLC dba Vangard Labs
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-07-09
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 2027-12-31
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
Listing expiration 2027-12-31 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 0615-8613-05 Adult Low Dose Aspirin 15 in 1 BLISTER PACK TABLET, DELAYED RELEASE 15 1 0615-8613-39 Adult Low Dose Aspirin 30 in 1 BLISTER PACK TABLET, DELAYED RELEASE 30 1
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 Sample Exclude flag Status 0615-8613-05 00615861305 15 TABLET, DELAYED RELEASE in 1 BLISTER PACK (0615-8613-05) 2026-01-16 No No Current 0615-8613-39 00615861339 30 TABLET, DELAYED RELEASE in 1 BLISTER PACK (0615-8613-39) 2026-01-16 No No Current