Home NDC 84289-366-36 Pain Reliever / Low Dose Aspirin
Product NDC 84289-366
Requested package NDC 84289-366-36
11-digit product format 842890366
Labeler code 84289
Product ID 84289-366_4aa69fbd-12a9-5078-e063-6294a90aade7
Type HUMAN OTC DRUG
Nonproprietary name Aspirin
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler PHARMAMED USA INC
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-10-01
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 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 Pain Reliever / 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 318272 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 84289-366-36 Pain Reliever / Low Dose Aspirin 36 in 1 BOTTLE, PLASTIC TABLET, CHEWABLE 36 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84289-366 PAIN RELIEVER / LOW DOSE ASPIRIN (ASPIRIN) TABLET, CHEWABLE [PHARMAMED USA INC] 4 Current NDC, 1 package rows 20241001_1a3ff0da-85eb-542c-e063-6294a90a9cca.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 1 · 1 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 84289-366-36 84289036636 36 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (84289-366-36) 2024-10-01 Yes No Current