childrens acetaminophen

Generic: childrens acetaminophen oral

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

Drug Facts

Product Profile

Brand Name childrens acetaminophen
Generic Name childrens acetaminophen oral
Labeler aarna usa inc.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

acetaminophen 160 mg/5mL

Manufacturer
AARNA USA INC.

Identifiers & Regulatory

Product NDC 82568-0010
Product ID 82568-0010_38070d2d-e016-7d5c-e063-6394a90a71ac
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M013
Listing Expiration 2026-12-31
Marketing Start 2025-06-20

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 825680010
Hyphenated Format 82568-0010

Supplemental Identifiers

RxCUI
307668
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 childrens acetaminophen (source: ndc)
Generic Name childrens acetaminophen oral (source: ndc)
Application Number M013 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 160 mg/5mL
source: ndc
Packaging
  • 60 mL in 1 BOTTLE (82568-0010-2)
  • 118 mL in 1 BOTTLE (82568-0010-4)
  • 473 mL in 1 BOTTLE (82568-0010-6)
  • 236 mL in 1 BOTTLE (82568-0010-8)
source: ndc

Packages (4)

82568-0010-2 60 mL in 1 BOTTLE (82568-0010-2) 82568-0010-4 118 mL in 1 BOTTLE (82568-0010-4) 82568-0010-6 473 mL in 1 BOTTLE (82568-0010-6) 82568-0010-8 236 mL in 1 BOTTLE (82568-0010-8)

Ingredients (1)

acetaminophen (160 mg/5mL)

Linked Drug Pages (1)

CHILDRENS ACETAMINOPHEN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "38070d2d-e016-7d5c-e063-6394a90a71ac", "openfda": {"unii": ["362O9ITL9D"], "rxcui": ["307668"], "spl_set_id": ["38070d15-2678-4e59-e063-6294a90ab690"], "manufacturer_name": ["AARNA USA INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 mL in 1 BOTTLE (82568-0010-2)", "package_ndc": "82568-0010-2", "marketing_start_date": "20250620"}, {"sample": false, "description": "118 mL in 1 BOTTLE (82568-0010-4)", "package_ndc": "82568-0010-4", "marketing_start_date": "20250620"}, {"sample": false, "description": "473 mL in 1 BOTTLE (82568-0010-6)", "package_ndc": "82568-0010-6", "marketing_start_date": "20250620"}, {"sample": false, "description": "236 mL in 1 BOTTLE (82568-0010-8)", "package_ndc": "82568-0010-8", "marketing_start_date": "20250620"}], "brand_name": "CHILDRENS ACETAMINOPHEN", "product_id": "82568-0010_38070d2d-e016-7d5c-e063-6394a90a71ac", "dosage_form": "SUSPENSION", "product_ndc": "82568-0010", "generic_name": "CHILDRENS ACETAMINOPHEN ORAL", "labeler_name": "AARNA USA INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "CHILDRENS ACETAMINOPHEN", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "160 mg/5mL"}], "application_number": "M013", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250620", "listing_expiration_date": "20261231"}