Last updated: June 1, 2026
Advil Cold and Sinus Suppliers (API, Contract Manufacturers, Packaging) and Supply Chain Risks
Executive summary: “Advil Cold and Sinus” is a branded, multi-ingredient OTC cold/cough combination marketed by GSK Consumer Healthcare (now Haleon) in the US. The supply chain is typically split across (1) API and key raw material sourcing, (2) contract manufacturing of finished dosage forms (tablets/capsules/liquids depending on the specific SKU strength), and (3) packaging/secondary processing. Supplier visibility at the API level is inconsistent in public sources for OTC combinations, so the most reliable public supplier mapping comes from FDA labeling, distributor/manufacturer-of-record statements on packaging, and corporate contracting patterns used for Haleon and its authorized manufacturers.
Result: A definitive, SKU-level list of all API and contract manufacturing suppliers cannot be produced from public data in a complete and accurate way.
Who manufactures Advil Cold and Sinus in the US?
Advil Cold and Sinus is manufactured and distributed under Haleon’s OTC consumer healthcare business in the US. Manufacturer-of-record and distributor information is reflected on the specific product’s FDA label and carton/insert (these can vary by strength, dosage form, and market). Public supplier lists that are complete at the “name every API supplier” or “name every CMO site” level are not consistently available for OTC combination products.
What dosage forms and active ingredients are typical?
Advil Cold and Sinus formulations in the US generally include ibuprofen plus a decongestant/antihistamine component and sometimes additional symptom agents depending on the SKU (for example, a pseudoephedrine- or phenylephrine-based decongestant, and in some versions an antihistamine). Exact ingredient set varies by formulation and year.
How to identify the manufacturer-of-record
The highest-signal public artifacts are:
- FDA OTC drug product labeling
- National Drug Code (NDC) label content attached to the product listing
- Carton/insert “Manufactured for” and “Distributed by” statements
What suppliers provide ibuprofen and cold-and-sinus combination ingredients?
For multi-ingredient OTC combinations, the sourcing pattern usually looks like this:
- Ibuprofen API and key intermediates: sourced from global API manufacturers and intermediate suppliers with GMP compliance.
- Decongestant API (commonly phenylephrine or pseudoephedrine salt forms): sourced from specialized API suppliers.
- Other symptom APIs (antihistamines, cough/cold adjuncts depending on SKU): sourced from additional API vendors.
Public sources rarely disclose the complete vendor list for each API used in each finished SKU. Brand owners and their CMOs usually treat supplier rosters as confidential.
Which contract manufacturing organizations (CMOs) make Advil Cold and Sinus tablets or capsules?
OTC combinations are commonly produced by:
- The brand owner’s internal manufacturing network, or
- Authorized contract manufacturers with site-level GMP capability and packaging line capacity for OTC labeling requirements.
A complete CMO roster for “Advil Cold and Sinus” cannot be compiled accurately from public data for all strengths/SKUs because:
- labels and NDC assignments can change by packaging site and formulation;
- supplier-of-record language is not consistently standardized across product versions.
What API suppliers are used for ibuprofen in OTC combinations like Advil Cold and Sinus?
Public disclosure for ibuprofen API sourcing is incomplete for any specific OTC finished product SKU. However, industry-wide ibuprofen API supply is concentrated among GMP-compliant global API producers, with multiple redundant sources used to manage supply continuity.
For litigation and procurement planning, the accurate approach is to map:
- the finished product’s NDC to its specific label/manufacturing site and
- the manufacturing site to its typical procurement contracts and qualified supplier lists.
Public sources alone are not sufficient to name each ibuprofen API supplier for this specific branded OTC combination.
How does Haleon’s supply chain structure affect Advil Cold and Sinus sourcing?
Haleon’s OTC business generally operates through:
- internal GMP manufacturing for some product lines, and
- external manufacturing and packaging partners for others, depending on capacity and cost.
For a multi-ingredient product like Advil Cold and Sinus, supply continuity depends on synchronized availability across all APIs plus packaging components, such as:
- tablet/capsule press and coating materials,
- controlled-release coatings (if used for any symptom component),
- bottle/label systems and child-resistant packaging (where required).
What packaging and secondary manufacturing suppliers support Advil Cold and Sinus?
Packaging vendors typically include suppliers of:
- high-speed bottle filling lines,
- blister pack tooling (if blister forms exist for a given SKU),
- carton and label printing,
- child-resistant closure systems (if used).
Again, the complete list of packaging partners for “Advil Cold and Sinus” varies by SKU and distribution channel and is not reliably discoverable from public records alone.
What supply chain risks exist for Advil Cold and Sinus ingredients?
Key OTC combination supply risks:
- API shortages driven by batch failures, plant downtime, or raw material constraints.
- Regulatory/quality events impacting API availability or finished product release timelines.
- Decongestant API volatility due to demand swings and manufacturing capacity constraints across global suppliers.
- Packaging component lead-time risk (closures, labels, cartons, desiccants) that can delay release even when APIs are available.
How to map exact Advil Cold and Sinus suppliers by NDC for procurement or due diligence?
A procurement-grade supplier mapping for this brand requires tying every SKU to:
- its NDC,
- its “manufactured for” entity on the label,
- the listed manufacturing site(s),
- the distributor details on the carton,
- the FDA listing associated with that NDC.
Public web search alone will not deliver a complete API supplier list. The deliverable that can be built with high accuracy is the “finished product manufacturer-of-record + packaging site,” which is typically sufficient for contracting and supply qualification.
Key Takeaways
- “Advil Cold and Sinus” is supplied through Haleon’s US OTC network, with manufacturer-of-record and packaging partners that can vary by SKU and NDC.
- Public sources do not support a complete, accurate, supplier-by-supplier list for APIs and CMOs tied to this exact branded combination across all strengths.
- The most reliable method to identify suppliers for procurement is NDC-specific mapping to label “manufactured for” and manufacturing/distribution statements, then qualification of the linked manufacturing and packaging sites.
FAQs
- What is the manufacturer-of-record for Advil Cold and Sinus for a specific NDC?
- Do different NDCs of Advil Cold and Sinus use different manufacturing sites?
- Which ingredient is the primary supply constraint in Advil Cold and Sinus: ibuprofen or the decongestant?
- How do changes in packaging (bottle vs blister) affect supplier qualification for Advil Cold and Sinus?
- Are API suppliers for branded OTC combinations disclosed publicly in FDA databases?
References (APA)
- Food and Drug Administration. (n.d.). OTC drug product listings and label information (NDC-based). U.S. FDA.
- Haleon. (n.d.). Product labeling and OTC brand portfolio materials for consumer healthcare products.
