PEDIATRIC ADVIL: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Haleon Us Holdings	PEDIATRIC ADVIL	ibuprofen	SUSPENSION/DROPS;ORAL	020812	NDA	Haleon US Holdings LLC	0573-0191-20	1 BOTTLE, DROPPER in 1 CARTON (0573-0191-20) / 15 mL in 1 BOTTLE, DROPPER	1998-01-30
Haleon Us Holdings	PEDIATRIC ADVIL	ibuprofen	SUSPENSION/DROPS;ORAL	020812	NDA	Haleon US Holdings LLC	0573-0191-22	1 BOTTLE, DROPPER in 1 CARTON (0573-0191-22) / 15 mL in 1 BOTTLE, DROPPER	1998-01-30
Haleon Us Holdings	PEDIATRIC ADVIL	ibuprofen	SUSPENSION/DROPS;ORAL	020812	NDA	Haleon US Holdings LLC	0573-0191-50	1 BOTTLE, DROPPER in 1 CARTON (0573-0191-50) / 30 mL in 1 BOTTLE, DROPPER	1998-01-30
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: May 25, 2026

Pediatric Advil (Ibuprofen) Suppliers: Who Manufactures, Sells, and Supplies the U.S. Market

Executive summary: Pediatric Advil is a U.S. branded ibuprofen pediatric formulation (oral suspension) supplied through a network of brand-owning, manufacturing, and distribution entities. In the U.S., Advil brands are marketed by McNeil Consumer Healthcare (J&J Consumer/OTC segment), with manufacturing and finished-goods supply typically sourced via contracted domestic and international drug substance and finished dosage suppliers. Without the exact Pediatric Advil product configuration (strength, dosage form, package size, NDC) and the current FDA Orange Book/NDC package data, supplier identification cannot be completed accurately.

Who are the suppliers for Pediatric Advil (ibuprofen) oral suspension?

Fast answer: Pediatric Advil suppliers map to three layers:

Brand owner/marketing authorization holder (OTC): entity responsible for OTC brand labeling and FDA compliance.
Finished dosage manufacturer: contract or in-house site(s) producing the pediatric ibuprofen suspension under cGMP.
Distribution channel: wholesale distributors and secondary logistics suppliers supplying pharmacies, mass retailers, and e-commerce channels.

What determines “supplier” for Pediatric Advil searches?

Searchers usually mean one of the following:

Who makes the finished suspension (cGMP manufacturer)
Who makes the API (ibuprofen) (drug substance supplier)
Who is listed on the bottle/label (manufacturer, packer, or distributor)
Which NDC labeler is on FDA systems (labeler on NDC)
Who supplies through wholesalers (distribution firms)

Each maps to different data fields, and conflating them leads to incorrect supplier lists.

What companies manufacture Pediatric Advil ibuprofen suspension in the U.S.?

Fast answer: Finished dosage manufacturing for Advil-branded pediatric ibuprofen is typically executed by one or more contract/manufacturing sites listed on:

the product label (manufacturer/packager)
the FDA NDC Directory labeler and establishment details
OTC product listings in FDA records linked to the specific NDC

Why multiple manufacturers show up for the same brand

Scale-up or site-specific scheduling
Package configuration changes
Regulatory submissions and annual re-qualification of labeling
Contracting arrangements that shift over time

Which suppliers provide ibuprofen drug substance for Pediatric Advil?

Fast answer: Ibuprofen drug substance is sourced through specialized API supply chains. For brand OTC pediatric ibuprofen, API sourcing commonly involves:

API producers that supply ibuprofen API (and polymorph or grade specifications)
Contract manufacturers that formulate finished suspensions

How API and finished dosage suppliers differ

API suppliers supply ibuprofen meeting pharmacopeial/specification requirements.
Finished dosage suppliers produce the ibuprofen suspension with specified excipient systems, viscosity control, flavoring, and pediatric dosing accuracy.

What is the Orange Book status of Pediatric Advil (ibuprofen) and does it list suppliers?

Fast answer: Orange Book listing is typically for approved prescription products with active ingredients supported by patent/regulatory exclusivity. Many OTC products are not listed in the Orange Book in the same way as prescription NDAs. Supplier details for OTC products more reliably come from the FDA NDC Directory and product labeling rather than Orange Book patent tables.

Where to find manufacturer/labeler data for OTC Pediatric Advil

FDA NDC Directory: labeler and NDC-linked product details
Product labeling: “manufactured for” / “distributed by” and packager/manufacturer lines
WHOLESALER listings: item master and trading partner data

How can distributors and wholesalers supply Pediatric Advil?

Fast answer: Pediatric Advil is distributed through:

national pharmaceutical wholesalers
regional distributors
direct-to-retail and retail distribution agreements

Typical distribution route (U.S.)

Finished goods manufacturer produces under labeler branding
Product released to distribution channel
Wholesaler warehouses and delivers to pharmacies and retailers
Retail shelves and e-commerce fulfill orders

What suppliers support Pediatric Advil manufacturing and packaging (bottling, labeling, fill-finish)?

Fast answer: The supply chain commonly includes:

Bulk suspension formulation sites (mixing, milling if needed)
Fill-finish sites (filling into bottles and caps)
Primary packaging and labeling (bottle label printing, cartons, child-resistant packaging)

Packaging-specific suppliers matter for recalls and shortages

Bottling/labeling sites can differ across NDCs and package sizes.
Lot-level traceability depends on fill-finish and pack-out sites, not only API producers.

What supplier risks affect Pediatric Advil availability (shortages and recalls)?

Fast answer: The main drivers of supply disruption for pediatric ibuprofen suspension include:

fill-finish capacity constraints
excipient supply availability (viscosity modifiers, suspending agents)
QA/QC release delays
packaging procurement issues (bottle size, child-resistant closures)

Which generics compete with Pediatric Advil and who supplies them?

Fast answer: Pediatric ibuprofen suspension has many branded and generic equivalents. Generic suppliers can differ by:

NDC labeler
formulation (same strength but different excipient system)
distribution agreements

Comparison: branded Pediatric Advil vs generic ibuprofen suspension supply chains

Branded supply can use fewer manufacturing sites but higher branding overhead.
Generics often add more labelers and more sites to maintain volume and pricing competitiveness.

How to map Pediatric Advil suppliers for procurement and sourcing (pharma-grade due diligence)?

Fast answer: For sourcing and supplier qualification, procurement teams typically need:

manufacturer site name and address from label/NDC
establishment registration and cGMP inspection history for that site
quality agreement requirements (CoA, testing, stability, microbiology controls)
lot traceability and recall capability (fill-finish lot mapping)

Due diligence items procurement teams require

Quality agreement scope (GMP, QC release responsibilities)
Change control history for formulation and packaging
Serialization/track-and-trace readiness if applicable
Excipient supplier qualification chain

Key Takeaways

“Pediatric Advil suppliers” breaks into brand owner, finished dosage manufacturer, and distribution channel, and each is sourced from different FDA and commercial datasets.
Finished dosage manufacturing and packaging suppliers are best identified from the specific product NDC and label line.
API supply is a separate upstream category and does not always align with the finished-dose manufacturer.
Supplier risk for pediatric ibuprofen suspension is frequently tied to fill-finish and packaging capacity as much as API availability.
A definitive supplier list requires exact product identification (NDC or bottle label manufacturer/labeler lines), because Pediatric Advil configurations can vary.

FAQs

How do I identify the manufacturer of a specific Pediatric Advil bottle?
Use the exact NDC printed on the carton/bottle and cross-reference the FDA NDC Directory labeler and manufacturer/packager lines.
Do Pediatric Advil OTC products have Orange Book patents listed?
Many OTC ibuprofen formulations are not handled in the same Orange Book patent framework as prescription products; supplier identification is usually done via NDC and labeling.
Which data points matter most for supplier qualification of Pediatric Advil?
cGMP manufacturing site, quality agreement scope, batch release testing, excipient controls, and lot traceability mapping.
Why do the same Pediatric Advil strength have different suppliers across NDCs?
Different package sizes and distribution runs can be produced by different contracted sites to meet capacity and compliance requirements.
What typically causes Pediatric ibuprofen suspension shortages?
Fill-finish and packaging constraints, excipient supply issues, and QA release timing are common contributors.

References (APA)

U.S. Food and Drug Administration. FDA NDC Directory. https://www.accessdata.fda.gov/scripts/cder/ndc/
U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/

Suppliers and packagers for PEDIATRIC ADVIL

PEDIATRIC ADVIL