Home NDC 57237-304 Acetaminophen
Product NDC 57237-304
11-digit product format 572370304
Labeler code 57237
Product ID 57237-304_cfbf13dc-6831-476c-927c-b09ea288c878
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form SOLUTION
Route ORAL
Labeler Rising Pharma Holdings, Inc.
Application M013.50
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-08-10
Substance ACETAMINOPHEN
Active strength 160 mg/5mL
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 160 mg/5mL
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 307675 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 57237-304-12 Acetaminophen 118 mL in 1 BOTTLE, PLASTIC SOLUTION 118 2 57237-304-16 Acetaminophen 473 mL in 1 BOTTLE, PLASTIC SOLUTION 473 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57237-304 ACETAMINOPHEN SOLUTION [RISING PHARMA HOLDINGS, INC.] 2 Current NDC, 2 package rows 20241019_319ede76-110e-4902-a931-39a6d3b8c731.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 1 · 1 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 57237-304-12 57237030412 118 mL in 1 BOTTLE, PLASTIC (57237-304-12) 118 ml 2023-08-10 No No Current 57237-304-16 57237030416 473 mL in 1 BOTTLE, PLASTIC (57237-304-16) 473 ml 2023-08-10 No No Current