Home NDC 81522-104 Acetaminophen
Product NDC 81522-104
11-digit product format 815220104
Labeler code 81522
Product ID 81522-104_24996677-f6f7-01be-e063-6394a90a10d7
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 2023-01-11
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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 81522-104-04 AcetaminophenExtra Strength 1 in 1 CARTON TABLET, COATED 1 4 81522-104-04 AcetaminophenExtra Strength 100 in 1 BOTTLE, PLASTIC TABLET, COATED 100 4 81522-104-06 AcetaminophenExtra Strength 500 in 1 BOTTLE, PLASTIC TABLET, COATED 500 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81522-104 ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [FSA STORE INC.] 4 Current NDC, Legacy NDC, 3 package rows 20241018_ec6add55-f4a3-7818-e053-2a95a90aee04.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 Marketing end Sample Exclude flag Status 81522-104-04 81522010404 1 BOTTLE, PLASTIC in 1 CARTON (81522-104-04) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC 2023-01-11 0000-00-00 No No Current 81522-104-06 81522010406 500 TABLET, COATED in 1 BOTTLE, PLASTIC (81522-104-06) 2023-05-03 No No Current