puregen labs acetaminophen

Generic: acetaminophen

Labeler: advanced rx llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name puregen labs acetaminophen
Generic Name acetaminophen
Labeler advanced rx llc
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

acetaminophen 500 mg/15mL

Manufacturer
Advanced Rx LLC

Identifiers & Regulatory

Product NDC 80513-001
Product ID 80513-001_474580a4-7e34-16bc-e063-6394a90a927d
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M013
Listing Expiration 2026-12-31
Marketing Start 2025-12-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 80513001
Hyphenated Format 80513-001

Supplemental Identifiers

RxCUI
307684
UPC
0380513001139
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 puregen labs acetaminophen (source: ndc)
Generic Name acetaminophen (source: ndc)
Application Number M013 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/15mL
source: ndc
Packaging
  • 237 mL in 1 BOTTLE (80513-001-13)
source: ndc

Packages (1)

80513-001-13 237 mL in 1 BOTTLE (80513-001-13)

Ingredients (1)

acetaminophen (500 mg/15mL)

Linked Drug Pages (1)

Puregen Labs Acetaminophen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "474580a4-7e34-16bc-e063-6394a90a927d", "openfda": {"upc": ["0380513001139"], "unii": ["362O9ITL9D"], "rxcui": ["307684"], "spl_set_id": ["474580af-f6b0-e440-e063-6394a90aaada"], "manufacturer_name": ["Advanced Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "237 mL in 1 BOTTLE (80513-001-13)", "package_ndc": "80513-001-13", "marketing_start_date": "20251201"}], "brand_name": "Puregen Labs Acetaminophen", "product_id": "80513-001_474580a4-7e34-16bc-e063-6394a90a927d", "dosage_form": "LIQUID", "product_ndc": "80513-001", "generic_name": "Acetaminophen", "labeler_name": "Advanced Rx LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Puregen Labs Acetaminophen", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "500 mg/15mL"}], "application_number": "M013", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20251201", "listing_expiration_date": "20261231"}