Home NDC 80513-001 Puregen Labs Acetaminophen
Product NDC 80513-001
11-digit product format 805130001
Labeler code 80513
Product ID 80513-001_474580a4-7e34-16bc-e063-6394a90a927d
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form LIQUID
Route ORAL
Labeler Advanced Rx LLC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-12-01
Substance ACETAMINOPHEN
Active strength 500 mg/15mL
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 Puregen Labs Acetaminophen
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 500 mg/15mL
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 307684 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 80513-001-13 Puregen Labs Acetaminophen 237 mL in 1 BOTTLE LIQUID 237 1
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 80513-001-13 80513000113 237 mL in 1 BOTTLE (80513-001-13) 237 ml 2025-12-01 No No Current