Last updated: May 26, 2026
Suppliers for Advil Congestion Relief (ibuprofen + pseudoephedrine): who manufactures, holds licenses, and ships
Executive summary: “Advil Congestion Relief” is a private-label US OTC product that combines ibuprofen with pseudoephedrine for nasal congestion relief. In practice, supply chains are split between (1) API manufacturers for ibuprofen and pseudoephedrine and (2) OTC packaging and distribution partners that produce the finished tablets under a labeler’s US regulatory umbrella. Public supplier visibility is highest for NDC-level finished-goods manufacturing (listed on FDA product labels and via commercial/labeler reporting) and for API sources (commercially disclosed in supplier registries and some DMFs/CEP-related disclosures). Without the specific NDC/strength/form for “Advil Congestion Relief” in the question, this request cannot be answered with hard, verifiable supplier names at NDC and API level.
Which companies supply the finished tablets for “Advil Congestion Relief” by NDC?
Featured snippet answer: The identity of the finished-goods manufacturer depends on the exact NDC for the specific Advil Congestion Relief presentation (strength and pack size). The NDC maps to a specific labeler and often to a specific manufacturer of record on FDA labeling and retailer packaging.
What to map first: NDC, labeler, and “manufactured for” language
- NDC is the key for identifying:
- Labeler (marketing authorization holder for the OTC listing)
- Manufacturer of record (finished dosage form site)
- Package configuration (bottle count, blister vs bottle, etc.)
- For OTC combination products, “Advil” often appears as the brand label while the underlying manufacturing is performed by a contracted or corporate manufacturing entity.
Finished-goods manufacturing: common supplier types
- Contract manufacturers that do:
- tablet pressing and coating
- granulation, blending, and packaging
- OTC secondary packaging
- Corporate manufacturing divisions within the brand owner or its CMOs.
What API suppliers produce ibuprofen for Advil Congestion Relief (ibuprofen)
Featured snippet answer: Ibuprofen is widely sourced globally through multiple API plants. For a specific OTC branded product, the API supplier cannot be pinned down reliably without the DMF-to-product crosswalk (often not published) and the API vendor statement for the relevant lot.
Typical supply chain for ibuprofen
- API plants that produce:
- ibuprofen bulk drug substance
- polymorph-controlled grades (where applicable)
- Quality and regulatory documentation:
- DMF submissions (US) and/or CEPs (Europe)
- supplier qualification in the brand owner’s purchasing system
What “supplier” means in API terms
For ip litigation and regulatory diligence, “supplier” can mean:
- API plant (site producing the API)
- DMF holder/letter of authorization holder
- Distributor supplying into the finished-goods manufacturer
Which companies supply pseudoephedrine API for OTC congestion relief
Featured snippet answer: Pseudoephedrine API has constrained sourcing due to regulatory controls and controlled-substance-adjacent manufacturing oversight. As with ibuprofen, exact API plant attribution for “Advil Congestion Relief” requires NDC/lot-level vendor mapping.
Why pseudoephedrine supplier visibility is lower
- Pseudoephedrine is subject to:
- stringent transaction reporting frameworks in many jurisdictions
- audit and qualification requirements
- Brand owners frequently use vetted API supply networks and may change vendors by lot or region.
How do brand owners structure contracting for Advil Congestion Relief (CMO vs in-house)?
Featured snippet answer: For OTC fixed-dose combinations, the brand labeler typically contracts either:
- a specialized OTC CMO for finished tablets and packaging, or
- a corporate manufacturing affiliate that produces the tablet core and packaging under labeler oversight.
Regulatory logic behind the contracting model
- The labeler retains:
- OTC regulatory obligations for adverse event reporting and labeling
- quality agreements
- The manufacturer of record retains:
- current Good Manufacturing Practice (cGMP) responsibilities for the dosage form
- batch release documentation
What OTC manufacturers package ibuprofen + pseudoephedrine tablets under private label programs?
Featured snippet answer: OTC tablet CMO ecosystems frequently support combination analgesic/decongestant products. The actual manufacturer for Advil Congestion Relief is NDC-dependent.
Contract packaging/manufacturing categories
- Tablet CMO (core formulation and tableting)
- Secondary packer (bottling, labeling, carton packing)
- Distribution network (wholesalers, national retailers)
How do you identify the actual supplier for “Advil Congestion Relief” without guessing?
Featured snippet answer: Use the specific NDC and read:
- the “Manufactured for” block on the outer carton and blister/bottle label
- the FDA listing tied to that NDC
- the lot release labeling (sometimes includes manufacturer site)
High-confidence identification fields
- “Manufactured for [labeler name] by [manufacturer name]”
- manufacturer address or site code
- NDC mapping tables in OTC listings and commercial product directories
Timeline: when can suppliers change for Advil Congestion Relief?
Featured snippet answer: Suppliers can change at multiple points:
- API vendor changes: typically tied to qualification cycles and supply continuity needs
- Finished-goods changes: often tied to contract renewal, plant capacity, and packaging line availability
- Lot-by-lot vendor substitution can occur if approved under quality agreements.
What triggers supplier switches
- cGMP site capacity constraints
- regulatory inspection outcomes
- supply shortages in pseudoephedrine procurement
- cost and tender cycles
Key takeaways
- “Advil Congestion Relief” supply identification is NDC-dependent at the finished-goods level.
- API sourcing for ibuprofen and pseudoephedrine is multi-supplier by design, and exact plant attribution needs product-specific mapping (NDC/lot/labeler/manufacturer of record).
- For diligence, supplier confirmation should rely on:
- the manufactured-for block on the product label and
- the NDC listing that links to the manufacturer of record.
FAQs
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How do I find the finished-goods manufacturer for an Advil congestion NDC?
Use the product’s specific NDC and check the “manufactured for” and manufacturer lines on the carton and FDA-linked listing.
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Do ibuprofen and pseudoephedrine suppliers stay the same for every lot of Advil Congestion Relief?
Not necessarily; vendors can change after qualification and approved quality agreements.
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Are there CMO manufacturers that specialize in OTC ibuprofen + pseudoephedrine tablets?
Yes, but the correct one for Advil Congestion Relief is determined by the NDC manufacturer-of-record.
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What documents show the pseudoephedrine API source for an OTC branded product?
DMF-linked references and commercial supply qualification records, plus regulatory submissions that are not always public at the finished-product level.
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When do supplier changes require regulatory updates for OTC combination drugs?
Changes typically require updated quality documentation and, when relevant, regulatory notifications or supplements tied to manufacturing site and controls.
References (APA)
(No sources were cited because the question does not provide an NDC/strength/form, and naming specific suppliers would require verifiable product-specific documentation.)
