Home NDC 72090-038-01 ACETAMINOPHEN 500 MG
Product NDC 72090-038
Requested package NDC 72090-038-01
11-digit product format 720900038
Labeler code 72090
Product ID 72090-038_e622e006-df18-4e5d-ae1b-03e1bea9bf21
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 2025-01-09
Substance ACETAMINOPHEN
Active strength 500 mg/1
NDC exclude flag No
Listing certified through 2027-12-31
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 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 500 mg/1
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72090-038-01 ACETAMINOPHEN 500 MG 500 in 1 BOTTLE TABLET 500 1 72090-038-02 ACETAMINOPHEN 500 MG 300 in 1 PACKAGE TABLET 300 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72090-038 ACETAMINOPHEN 500 MG (ACETAMINOPHEN) TABLET [PIONEER LIFE SCIENCES, LLC] 1 Current NDC, 2 package rows 20250110_e817bc4a-43ef-4126-b903-aabd1390cd0c.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 78 of 79 · 1,576 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 72090-038-01 72090003801 500 TABLET in 1 BOTTLE (72090-038-01) 500 tablet 2025-01-09 No No Current