Home NDC 57237-347-01 Acetaminophen
Product NDC 57237-347
Requested package NDC 57237-347-01
11-digit product format 572370347
Labeler code 57237
Product ID 57237-347_ffbb6e36-399b-40eb-96b4-b0406c712c0d
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 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
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 57237-347-01 Acetaminophen 100 in 1 BOTTLE TABLET, FILM COATED 100 2 57237-347-05 Acetaminophen 500 in 1 BOTTLE TABLET, FILM COATED 500 2
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 79 of 79 · 1,579 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 57237-347-01 57237034701 100 TABLET, FILM COATED in 1 BOTTLE (57237-347-01) 2025-07-09 No No Current