Home NDC 36800-545 Aspirin
Product NDC 36800-545
11-digit product format 368000545
Labeler code 36800
Product ID 36800-545_035fcef2-398e-401b-90b2-33cf5b522c04
Type HUMAN OTC DRUG
Nonproprietary name Aspirin
Dosage form TABLET, DELAYED RELEASE
Route ORAL
Labeler Topco Associates, LLC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-03-19
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 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 36800-545-60 Aspirin 180 in 1 BOTTLE, PLASTIC TABLET, DELAYED RELEASE 180 8 36800-545-60 Aspirin 1 in 1 CARTON TABLET, DELAYED RELEASE 1 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-545 ASPIRIN TABLET, DELAYED RELEASE [TOPCO ASSOCIATES, LLC] 6 Current NDC, Legacy NDC, 2 package rows 20250309_56c125de-fabf-41fa-88a4-760d2793f202.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 36800-545-60 36800054560 1 BOTTLE, PLASTIC in 1 CARTON (36800-545-60) / 180 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC 2021-03-19 0000-00-00 No No Current