dye free childrens 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 dye free childrens acetaminophen
Generic Name acetaminophen
Labeler pai holdings, llc dba pai pharma
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

acetaminophen 160 mg/5mL

Manufacturer
PAI Holdings, LLC dba PAI Pharma

Identifiers & Regulatory

Product NDC 0121-0966
Product ID 0121-0966_89d3db5b-5a3b-41d3-b2d1-223932ba25d1
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M013
Listing Expiration 2026-12-31
Marketing Start 2022-03-09

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01210966
Hyphenated Format 0121-0966

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 dye free childrens 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
  • 10 TRAY in 1 CASE (0121-0966-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0966-05)
  • 3 TRAY in 1 CASE (0121-0966-94) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0966-05)
source: ndc

Packages (2)

0121-0966-00 10 TRAY in 1 CASE (0121-0966-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0966-05) 0121-0966-94 3 TRAY in 1 CASE (0121-0966-94) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0966-05)

Ingredients (1)

acetaminophen (160 mg/5mL)

Linked Drug Pages (1)

Dye Free Childrens Acetaminophen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "89d3db5b-5a3b-41d3-b2d1-223932ba25d1", "openfda": {"unii": ["362O9ITL9D"], "rxcui": ["307668"], "spl_set_id": ["a69fca9d-c0a0-4321-bf03-5c8e99cc07cc"], "manufacturer_name": ["PAI Holdings, LLC dba PAI Pharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 TRAY in 1 CASE (0121-0966-00)  / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0966-05)", "package_ndc": "0121-0966-00", "marketing_start_date": "20220309"}, {"sample": false, "description": "3 TRAY in 1 CASE (0121-0966-94)  / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0966-05)", "package_ndc": "0121-0966-94", "marketing_start_date": "20220309"}], "brand_name": "Dye Free Childrens Acetaminophen", "product_id": "0121-0966_89d3db5b-5a3b-41d3-b2d1-223932ba25d1", "dosage_form": "SUSPENSION", "product_ndc": "0121-0966", "generic_name": "Acetaminophen", "labeler_name": "PAI Holdings, LLC dba PAI Pharma", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Dye Free Childrens Acetaminophen", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "160 mg/5mL"}], "application_number": "M013", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20220309", "listing_expiration_date": "20261231"}