Home NDC 54859-850-16 Llorens Care Children Acetaminophen
Product NDC 54859-850
Requested package NDC 54859-850-16
11-digit product format 548590850
Labeler code 54859
Product ID 54859-850_47461076-1bb3-ffd6-e063-6294a90a5885
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN
Dosage form SUSPENSION
Route ORAL
Labeler Llorens Pharmaceutical International Division, Inc.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-12-01
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 Llorens Care Children 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 307668 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 54859-850-04 Llorens Care Children Acetaminophen 118 mL in 1 BOTTLE SUSPENSION 118 2 54859-850-16 Llorens Care Children Acetaminophen 473 mL in 1 BOTTLE, PLASTIC SUSPENSION 473 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54859-850 LLORENS CARE CHILDREN ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION, INC.] 1 Current NDC, 2 package rows 20241228_2a46d7d2-293b-5024-e063-6294a90a31aa.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 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 54859-850-16 54859085016 473 mL in 1 BOTTLE, PLASTIC (54859-850-16) 473 ml 2024-12-01 No No Current