infants tylenol

Generic: acetaminophen

Labeler: kenvue brands llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name infants tylenol
Generic Name acetaminophen
Labeler kenvue brands llc
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

acetaminophen 160 mg/5mL

Manufacturer
Kenvue Brands LLC

Identifiers & Regulatory

Product NDC 50580-325
Product ID 50580-325_216fda4f-79f4-5cca-e063-6294a90a27a8
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M013
Listing Expiration 2026-12-31
Marketing Start 2017-09-25

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50580325
Hyphenated Format 50580-325

Supplemental Identifiers

RxCUI
307668 828555
UPC
0300450186607
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 infants tylenol (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 CARTON (50580-325-01) / 60 mL in 1 BOTTLE
source: ndc

Packages (1)

50580-325-01 1 BOTTLE in 1 CARTON (50580-325-01) / 60 mL in 1 BOTTLE

Ingredients (1)

acetaminophen (160 mg/5mL)

Linked Drug Pages (1)

Infants TYLENOL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "216fda4f-79f4-5cca-e063-6294a90a27a8", "openfda": {"upc": ["0300450186607"], "unii": ["362O9ITL9D"], "rxcui": ["307668", "828555"], "spl_set_id": ["997b9551-c222-4a9c-8ba1-09a5f97495fa"], "manufacturer_name": ["Kenvue Brands LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (50580-325-01)  / 60 mL in 1 BOTTLE", "package_ndc": "50580-325-01", "marketing_start_date": "20170925"}], "brand_name": "Infants TYLENOL", "product_id": "50580-325_216fda4f-79f4-5cca-e063-6294a90a27a8", "dosage_form": "SUSPENSION", "product_ndc": "50580-325", "generic_name": "Acetaminophen", "labeler_name": "Kenvue Brands LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Infants TYLENOL", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "160 mg/5mL"}], "application_number": "M013", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20170925", "listing_expiration_date": "20261231"}