acetaminophen

Generic: acetaminophen

Labeler: pai holdings, llc dba pai pharma
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name acetaminophen
Generic Name acetaminophen
Labeler pai holdings, llc dba pai pharma
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/10.15mL

Manufacturer
PAI Holdings, LLC dba PAI Pharma

Identifiers & Regulatory

Product NDC 0121-2094
Product ID 0121-2094_b5e3c4bc-f8bd-4206-9619-00e073429c50
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M013
Listing Expiration 2026-12-31
Marketing Start 2025-12-09

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01212094
Hyphenated Format 0121-2094

Supplemental Identifiers

RxCUI
307675
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 acetaminophen (source: ndc)
Generic Name acetaminophen (source: ndc)
Application Number M013 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/10.15mL
source: ndc
Packaging
  • 10 TRAY in 1 CASE (0121-2094-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 10.15 mL in 1 CUP, UNIT-DOSE (0121-2094-11)
source: ndc

Packages (1)

0121-2094-00 10 TRAY in 1 CASE (0121-2094-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 10.15 mL in 1 CUP, UNIT-DOSE (0121-2094-11)

Ingredients (1)

acetaminophen (325 mg/10.15mL)

Linked Drug Pages (1)

Acetaminophen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b5e3c4bc-f8bd-4206-9619-00e073429c50", "openfda": {"unii": ["362O9ITL9D"], "rxcui": ["307675"], "spl_set_id": ["355a094c-bed9-4959-8cf0-619f0e246105"], "manufacturer_name": ["PAI Holdings, LLC dba PAI Pharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 TRAY in 1 CASE (0121-2094-00)  / 10 CUP, UNIT-DOSE in 1 TRAY / 10.15 mL in 1 CUP, UNIT-DOSE (0121-2094-11)", "package_ndc": "0121-2094-00", "marketing_start_date": "20251209"}], "brand_name": "Acetaminophen", "product_id": "0121-2094_b5e3c4bc-f8bd-4206-9619-00e073429c50", "dosage_form": "SOLUTION", "product_ndc": "0121-2094", "generic_name": "Acetaminophen", "labeler_name": "PAI Holdings, LLC dba PAI Pharma", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Acetaminophen", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/10.15mL"}], "application_number": "M013", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20251209", "listing_expiration_date": "20261231"}