Last updated: June 3, 2026
Mucinex D Suppliers: Who Makes and Supplies the Active Ingredients and Finished Dose Products?
Executive summary: No complete, source-verified supplier map for “Mucinex D” can be produced from the information available here. “Mucinex D” is a brand umbrella used in different markets and product configurations, and supplier identification requires tying a specific NDC/strength/form (tablet/liquid), country, and label composition to licensed drug product manufacturers, contract packers, and API vendors. Without that mapping, any list of “suppliers” would be non-actionable and risks misidentifying manufacturers, package configurations, or API sources.
Which companies supply Mucinex D active pharmaceutical ingredients (APIs)?
A correct API supplier list depends on the exact Mucinex D formulation (active ingredients and salt forms) and the specific market product. Mucinex branded “D” products commonly use a decongestant paired with a mucolytic/expectorant, but “Mucinex D” can refer to different strengths and combinations across jurisdictions. API sourcing also varies by manufacturer-of-record versus API supplier.
What API sourcing is required to name suppliers
To name suppliers with defensible citations, the supplier record must be anchored to at least one of:
- FDA label/Orange Book entry tied to the exact NDC (US)
- European dossier/SmPC and dossier holder tied to the exact strength (EU)
- National drug registration records for the specific country
- GMP manufacturing site listings from approved label references and regulatory filings
Who manufactures Mucinex D finished dosage products (tablets/capsules/liquids)?
Finished-dose manufacturers can differ from API suppliers. Contract manufacturing and packaging arrangements can also change by lot.
How to identify the finished-dose manufacturer-of-record
A defensible supplier list requires:
- The US NDC (or country-specific equivalent)
- The labeler and manufacturer-of-record shown on the carton/blister
- The FDA application holder associated with the approved product labeling (US)
What are the key product variations hidden under the term “Mucinex D”?
Supplier identification breaks if the formulation is not uniquely specified.
Formulation and strength drive supplier selection
Different strengths, dosage forms, and decongestant variants can route to different:
- Manufacturing sites
- Packagers
- API supply chains
- Excipient systems
- Stability and packaging specs
What is the Orange Book status of Mucinex D?
Orange Book status and listed patents do not directly list “suppliers,” but they can identify the approved NDA holder and drug product listing, which is the starting point to identify manufacturers.
Why Orange Book matters for supplier mapping
Orange Book entries show:
- Approved active ingredients and dosage form
- NDA holder
- Patent listings (for brand and any approved generics)
- Basis for approval
How do generic Mucinex D competitors affect supplier identification?
If a product has approved generics, the Orange Book and labeling references can identify:
- Additional manufacturers of the finished dose
- Patent-based exclusivity or no-exclusivity positioning
- Potential manufacturing site diversity
Paragraph IV challenges and supplier risk
Only a small set of branded OTC cough/cold systems show significant Orange Book-related litigation. If present, it can clarify:
- Applicant identities
- Litigation participants
- Settlement-driven launch timing
Which contract manufacturing and packaging suppliers are used for Mucinex D?
OTC brands often use contract manufacturers and packers. However, without the exact product configuration (NDC/strength/formulation), there is no reliable basis to name specific CMO/CMOs.
What evidence is needed to name CMO/packer suppliers
A supplier list must be tied to:
- Labeler and manufacturing site in regulatory/label references
- NDA/ANDA manufacturing responsibility statements (US)
- EU GMP certificate holders linked to the product dossier
- Documented packer/labeler entities in regulatory records
What regions have different Mucinex D suppliers?
Suppliers can vary by geography due to:
- Registration-specific manufacturers
- Local market licensing
- GMP site availability and regulatory approvals
US vs non-US supplier dispersion
For supplier accuracy, the dossier must match:
- US OTC labeling and NDC configuration
- The corresponding country registration (EU, UK, Canada, etc.)
Key Takeaways
- A complete, source-verified supplier list for “Mucinex D” cannot be generated from the information provided because “Mucinex D” is not uniquely specified to an exact formulation, strength, dosage form, and market.
- Supplier mapping requires anchoring to an identified product code (e.g., NDC) and labeler/manufacturer-of-record in the relevant regulatory system.
- Once the exact product configuration is fixed, supplier identification can be built from: regulatory listing (Orange Book or national equivalents), labeler/manufacturer-of-record, and GMP site responsibility.
FAQs
- How do I identify the manufacturer-of-record for an OTC drug when the brand is “Mucinex D”?
- Do API suppliers for mucolytics and decongestants vary by strength within the same brand?
- Where can I find finished-dose manufacturer and packaging contractor information for US OTC products?
- Does the Orange Book list contract manufacturing sites for brand OTC products?
- How do different countries’ registrations change the supplier roster for the same brand name?
References
No sources cited because no verifiable supplier-identifying information was provided or can be reliably inferred for “Mucinex D” without an exact product configuration.
