Home NDC 82568-0010 CHILDRENS ACETAMINOPHEN
Product NDC 82568-0010
11-digit product format 825680010
Labeler code 82568
Product ID 82568-0010_38070d2d-e016-7d5c-e063-6394a90a71ac
Type HUMAN OTC DRUG
Nonproprietary name CHILDRENS ACETAMINOPHEN ORAL
Dosage form SUSPENSION
Route ORAL
Labeler AARNA USA INC.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-06-20
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 CHILDRENS 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 82568-0010-2 CHILDRENS ACETAMINOPHEN 60 mL in 1 BOTTLE SUSPENSION 60 1 82568-0010-4 CHILDRENS ACETAMINOPHEN 118 mL in 1 BOTTLE SUSPENSION 118 1 82568-0010-6 CHILDRENS ACETAMINOPHEN 473 mL in 1 BOTTLE SUSPENSION 473 1 82568-0010-8 CHILDRENS ACETAMINOPHEN 236 mL in 1 BOTTLE SUSPENSION 236 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 82568-0010-2 82568001002 60 mL in 1 BOTTLE (82568-0010-2) 60 ml 2025-06-20 No No Current 82568-0010-4 82568001004 118 mL in 1 BOTTLE (82568-0010-4) 118 ml 2025-06-20 No No Current 82568-0010-6 82568001006 473 mL in 1 BOTTLE (82568-0010-6) 473 ml 2025-06-20 No No Current 82568-0010-8 82568001008 236 mL in 1 BOTTLE (82568-0010-8) 236 ml 2025-06-20 No No Current