Home NDC 77333-031 Aspirin 81mg Enteric Coated
Product NDC 77333-031
11-digit product format 773330031
Labeler code 77333
Product ID 77333-031_327b3759-64de-dc54-e063-6394a90ac525
Type HUMAN OTC DRUG
Nonproprietary name Aspirin
Dosage form TABLET, DELAYED RELEASE
Route ORAL
Labeler Gendose Pharmaceuticals, LLC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-05-01
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 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 Aspirin 81mg Enteric Coated
Listing expiration 2026-12-31 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 77333-031-20 Aspirin 81mg Enteric Coated 150 in 1 CARTON TABLET, DELAYED RELEASE 150 1 77333-031-25 Aspirin 81mg Enteric Coated 1 in 1 BLISTER PACK TABLET, DELAYED RELEASE 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 77333-031 ASPIRIN 81MG ENTERIC COATED (ASPIRIN) TABLET, DELAYED RELEASE [GENDOSE PHARMACEUTICALS, LLC] 1 Current NDC, 2 package rows 20250501_7342bbf4-ebb9-446d-83bb-6ddcb3a44fa7.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 Units Marketing start Sample Exclude flag Status 77333-031-20 77333003120 150 BLISTER PACK in 1 CARTON (77333-031-20) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (77333-031-25) 150 blister pack 2025-05-01 No No Current 77333-031-25 77333003125 1 in 1 BLISTER PACK Historical