Home NDC 72090-008 ACETAMINOPHEN 500 MG
Product NDC 72090-008
11-digit product format 720900008
Labeler code 72090
Product ID 72090-008_5fa2212a-3bf2-43db-aedd-858124e4ed1d
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN
Dosage form TABLET
Route ORAL
Labeler Pioneer Life Sciences, LLC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-06-11
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 500 MG
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 72090-008-30 ACETAMINOPHEN 500 MG 300 in 1 BOTTLE TABLET 300 3 72090-008-01 ACETAMINOPHEN 500 MG 500 in 1 BOTTLE TABLET 500 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72090-008 ACETAMINOPHEN 500 MG (ACETAMINOPHEN) TABLET [PIONEER LIFE SCIENCES, LLC] 2 Current NDC, 1 package rows 20240423_11e6ec2a-5171-4496-a15f-6ff744bd1f2f.zip 72090-008 ACETAMINOPHEN 500 MG (ACETAMINOPHEN) TABLET [PIONEER LIFE SCIENCES, LLC] 1 Current NDC, 1 package rows 20240612_0d67bb52-7ae3-439e-9e47-4e21eb0ca352.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 72090-008-01 72090000801 500 TABLET in 1 BOTTLE (72090-008-01) 500 tablet 2024-06-11 No No Current 72090-008-30 72090000830 300 TABLET in 1 BOTTLE (72090-008-30) 300 tablet 2023-05-11 No No Current