Home NDC 81522-070 Acetaminophen
Product NDC 81522-070
11-digit product format 815220070
Labeler code 81522
Product ID 81522-070_1e780586-ce16-1d40-e063-6294a90a79ac
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form TABLET, COATED
Route ORAL
Labeler FSA STORE INC.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-07-30
Substance ACETAMINOPHEN
Active strength 500 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
Brand name suffix Extra Strength
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 500 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 198440 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 81522-070-13 AcetaminophenExtra Strength 225 in 1 BOTTLE, PLASTIC TABLET, COATED 225 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81522-070 ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [FSA STORE INC.] 2 Current NDC, 1 package rows 20240731_1cd6a3e6-1376-0b7b-e063-6394a90af3d1.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 Marketing start Sample Exclude flag Status 81522-070-13 81522007013 225 TABLET, COATED in 1 BOTTLE, PLASTIC (81522-070-13) 2024-07-30 No No Current