Home NDC 57237-346 Acetaminophen
Product NDC 57237-346
11-digit product format 572370346
Labeler code 57237
Product ID 57237-346_d19afb8f-7095-47fb-ae86-6efa69764655
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Rising Pharma Holdings, Inc.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-07-09
Substance ACETAMINOPHEN
Active strength 325 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
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 57237-346-01 Acetaminophen 100 in 1 BOTTLE TABLET, FILM COATED 100 4 57237-346-10 Acetaminophen 1000 in 1 BOTTLE TABLET, FILM COATED 1000 4
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 2 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 57237-346-01 57237034601 100 TABLET, FILM COATED in 1 BOTTLE (57237-346-01) 2025-07-09 No No Current 57237-346-10 57237034610 1000 TABLET, FILM COATED in 1 BOTTLE (57237-346-10) 2025-07-09 No No Current