Home NDC 77333-035 Aspirin
Product NDC 77333-035
11-digit product format 773330035
Labeler code 77333
Product ID 77333-035_50fc4202-32ea-7849-e063-6394a90a5a73
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 2026-05-15
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 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
Brand name suffix Enteric Coated, Regular Strength
Listing expiration 2027-12-31 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 198467 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 77333-035-20 AspirinEnteric Coated, Regular Strength 150 in 1 BOX TABLET, DELAYED RELEASE 150 1 77333-035-25 AspirinEnteric Coated, Regular Strength 1 in 1 BLISTER PACK TABLET, DELAYED RELEASE 1 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 2 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 77333-035-20 77333003520 150 BLISTER PACK in 1 BOX (77333-035-20) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (77333-035-25) 150 blister pack 2026-05-15 No No Current 77333-035-25 77333003525 1 in 1 BLISTER PACK Historical