Home NDC 82568-0009-8 Childrens Acetaminophen Oral Liquid
Product NDC 82568-0009
Requested package NDC 82568-0009-8
11-digit product format 825680009
Labeler code 82568
Product ID 82568-0009_39347f6d-dea6-d2c5-e063-6394a90a54b0
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form LIQUID
Route ORAL
Labeler AARNA USA INC.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-07-01
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 Childrens Acetaminophen Oral Liquid
Brand name suffix Grape Flavor
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 82568-0009-4 Childrens Acetaminophen Oral LiquidGrape Flavor 118 mL in 1 BOTTLE LIQUID 118 1 82568-0009-4 Childrens Acetaminophen Oral LiquidGrape Flavor 1 in 1 CARTON LIQUID 1 1 82568-0009-6 Childrens Acetaminophen Oral LiquidGrape Flavor 473 mL in 1 BOTTLE LIQUID 473 1 82568-0009-8 Childrens Acetaminophen Oral LiquidGrape Flavor 236 mL in 1 BOTTLE LIQUID 236 1 82568-0009-8 Childrens Acetaminophen Oral LiquidGrape Flavor 1 in 1 CARTON LIQUID 1 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 82568-0009-8 82568000908 1 BOTTLE in 1 CARTON (82568-0009-8) / 236 mL in 1 BOTTLE 1 bottle 2024-07-01 No No Current