Home NDC 61245-616 Direct Safety Aspirin
Product NDC 61245-616
11-digit product format 612450616
Labeler code 61245
Product ID 61245-616_3e5d77e9-913f-41d7-e063-6294a90a365e
Type HUMAN OTC DRUG
Nonproprietary name Aspirin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Direct Safety
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-02-15
Substance ASPIRIN
Active strength 325 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 2026-12-31
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 Direct Safety Aspirin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ASPIRIN 325 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 212033 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 61245-616-13 Direct Safety Aspirin 2 in 1 PACKET TABLET, FILM COATED 2 7 61245-616-13 Direct Safety Aspirin 250 in 1 BOX TABLET, FILM COATED 250 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61245-616 DIRECT SAFETY ASPIRIN (ASPIRIN) TABLET, COATED DIRECT SAFETY ASPIRIN (ASPIRIN) TABLET, FILM COATED [DIRECT SAFETY] 6 Current NDC, Legacy NDC, 2 package rows 20241030_ba9ba697-d3df-49d7-e053-2a95a90af406.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 84 · 1,663 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 61245-616-13 61245061613 250 PACKET in 1 BOX (61245-616-13) / 2 TABLET, FILM COATED in 1 PACKET 250 packet 2021-02-15 0000-00-00 No No Current