Home NDC 82568-0001-3 ACETAMINOPHEN
Product NDC 82568-0001
Requested package NDC 82568-0001-3
11-digit product format 825680001
Labeler code 82568
Product ID 82568-0001_33f0e822-28b0-9bb2-e063-6294a90a5175
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN
Dosage form TABLET
Route ORAL
Labeler AARNA USA INC.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-05-15
Substance ACETAMINOPHEN
Active strength 325 mg/1
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 ACETAMINOPHEN
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 313782 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 82568-0001-1 ACETAMINOPHEN 100 in 1 BOTTLE TABLET 100 1 82568-0001-2 ACETAMINOPHEN 1000 in 1 BOTTLE TABLET 1000 1 82568-0001-3 ACETAMINOPHEN 100 in 1 PACKAGE TABLET 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82568-0001 ACETAMINOPHEN TABLET [AARNA USA INC.] 1 Current NDC, 3 package rows 20250515_33f0e822-28af-9bb2-e063-6294a90a5175.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 82568-0001-3 82568000103 100 TABLET in 1 PACKAGE (82568-0001-3) 100 tablet 2025-05-15 No No Current