Home NDC 54859-809 Liquid Acetaminophen
Product NDC 54859-809
11-digit product format 548590809
Labeler code 54859
Product ID 54859-809_47461076-1bb2-ffd6-e063-6294a90a5885
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form LIQUID
Route ORAL
Labeler LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-10-01
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 Liquid 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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 54859-809-16 Liquid Acetaminophen 473 mL in 1 BOTTLE LIQUID 473 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54859-809 LIQUID ACETAMINOPHEN (ACETAMINOPHEN) LIQUID [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION] 4 Current NDC, Legacy NDC, 1 package rows 20241222_a7dbd4c0-53eb-4368-917b-1432c09ce6b4.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 49 of 79 · 1,579 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 54859-809-16 54859080916 473 mL in 1 BOTTLE (54859-809-16) 473 ml 2019-10-01 0000-00-00 No No Current