Home NDC 68391-063 Aspirin
Product NDC 68391-063
11-digit product format 683910063
Labeler code 68391
Product ID 68391-063_fa0a766e-b881-48b2-8234-4b400ece2d51
Type HUMAN OTC DRUG
Nonproprietary name Aspirin
Dosage form TABLET, COATED
Route ORAL
Labeler BJWC (Berkley & Jensen / BJ's)
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-08-20
Marketing end 2026-12-30
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
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Aspirin
Brand name suffix Low Dose Safety Coated 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 68391-063-50 AspirinLow Dose Safety Coated 500 in 1 BOTTLE, PLASTIC TABLET, COATED 500 4 68391-063-50 AspirinLow Dose Safety Coated 1 in 1 BOX TABLET, COATED 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68391-063 ASPIRIN LOW DOSE SAFETY COATED (ASPIRIN) TABLET, COATED [BJWC (BERKLEY & JENSEN / BJ'S)] 3 Current NDC, Legacy NDC, 2 package rows 20240224_577035a5-88ab-431c-8598-7a19dd633fe9.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 85 · 1,681 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 68391-063-50 68391006350 1 BOTTLE, PLASTIC in 1 BOX (68391-063-50) / 500 TABLET, COATED in 1 BOTTLE, PLASTIC 2021-08-20 2026-12-30 No No Current