children acetaminophen

Generic: acetaminophen

Labeler: aarna usa inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name children acetaminophen
Generic Name acetaminophen
Labeler aarna usa inc.
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

acetaminophen 160 mg/5mL

Manufacturer
AARNA USA INC.

Identifiers & Regulatory

Product NDC 82568-0008
Product ID 82568-0008_354289e0-a1d5-590d-e063-6394a90a2ec3
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M013
Listing Expiration 2026-12-31
Marketing Start 2025-02-18

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 825680008
Hyphenated Format 82568-0008

Supplemental Identifiers

RxCUI
307668
UPC
0382568000884
UNII
362O9ITL9D

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name children acetaminophen (source: ndc)
Generic Name acetaminophen (source: ndc)
Application Number M013 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 160 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 PACKAGE (82568-0008-4) / 118 mL in 1 BOTTLE
  • 473 mL in 1 BOTTLE (82568-0008-6)
  • 1 BOTTLE in 1 PACKAGE (82568-0008-8) / 236 mL in 1 BOTTLE
source: ndc

Packages (3)

82568-0008-4 1 BOTTLE in 1 PACKAGE (82568-0008-4) / 118 mL in 1 BOTTLE 82568-0008-6 473 mL in 1 BOTTLE (82568-0008-6) 82568-0008-8 1 BOTTLE in 1 PACKAGE (82568-0008-8) / 236 mL in 1 BOTTLE

Ingredients (1)

acetaminophen (160 mg/5mL)

Linked Drug Pages (1)

Children Acetaminophen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "354289e0-a1d5-590d-e063-6394a90a2ec3", "openfda": {"upc": ["0382568000884"], "unii": ["362O9ITL9D"], "rxcui": ["307668"], "spl_set_id": ["25bcb9d5-f388-4ae7-8037-970ffe8d17f0"], "manufacturer_name": ["AARNA USA INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 PACKAGE (82568-0008-4)  / 118 mL in 1 BOTTLE", "package_ndc": "82568-0008-4", "marketing_start_date": "20250218"}, {"sample": false, "description": "473 mL in 1 BOTTLE (82568-0008-6)", "package_ndc": "82568-0008-6", "marketing_start_date": "20250218"}, {"sample": false, "description": "1 BOTTLE in 1 PACKAGE (82568-0008-8)  / 236 mL in 1 BOTTLE", "package_ndc": "82568-0008-8", "marketing_start_date": "20250218"}], "brand_name": "Children Acetaminophen", "product_id": "82568-0008_354289e0-a1d5-590d-e063-6394a90a2ec3", "dosage_form": "LIQUID", "product_ndc": "82568-0008", "generic_name": "Acetaminophen", "labeler_name": "AARNA USA INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Children Acetaminophen", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "160 mg/5mL"}], "application_number": "M013", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250218", "listing_expiration_date": "20261231"}