Suppliers and packagers for CLARITIN-D 24 HOUR

What company owns CLARITIN-D 24 HOUR’s brand in the US?

CLARITIN-D 24 HOUR is a branded combination product of loratadine (antihistamine) and pseudoephedrine (decongestant). In the US, the label is marketed under the Schering-Plough brand family by Bristol Myers Squibb (BMS). The product’s US commercial ownership aligns with BMS’ heritage control of Schering-Plough brands (including loratadine products) and the long-running US OTC franchise.

Which suppliers make the drug product for CLARITIN-D 24 HOUR?

No complete, verifiable list of named third-party suppliers (API makers, excipient suppliers, or specific contract manufacturing sites) is available in the record provided. Without a cited label/filing dataset that names the manufacturer(s) and site(s) for the specific combination strength and dosage form, it is not possible to produce an accurate supplier map.

What inputs must be supplied to manufacture CLARITIN-D 24 HOUR?

Even where the upstream supplier names are not disclosed, CLARITIN-D 24 HOUR manufacturing requires defined input classes that are typically sourced through qualified supplier networks:

• APIs
  • Loratadine
  • Pseudoephedrine (for extended-release dosing)
• Oral solid dosage system
  • Extended-release (ER) matrix components (site- and technology-dependent)
  • Coating and controlled-release excipients
• Core tablet excipients
  • Binders, disintegrants, lubricants, and glidants
• Packaging supply chain
  • Unit-dose tablet packaging, child-resistant packaging components (for OTC formats)

How is CLARITIN-D 24 HOUR structured from a regulatory and supply standpoint?

From a sourcing lens, CLARITIN-D 24 HOUR is a combination ER tablet product. That structure drives supplier segmentation:

• API supply must match the release and dosing intent (ER pseudoephedrine exposure profile).
• Formulation and ER technology requires excipients and process inputs that are compatible with extended-release performance and dissolution specs.
• Batch release and regulatory compliance depend on supplier qualification for both APIs and critical excipients.

Does the OTC label disclose the contract manufacturer?

For many OTC products, the US package labeling discloses either:

• a single manufacturer/packager entity, or
• a site-specific manufacturing statement.

However, in the materials available in this conversation, the exact CLARITIN-D 24 HOUR label line(s) that name the manufacturer and packager are not present. Without the label text (or the relevant listing in the FDA database that enumerates the labeler and manufacturer of record for the specific NDC/strength), the supplier list cannot be completed accurately.

What can be confirmed about CLARITIN-D 24 HOUR’s drug substance identity?

The product is the fixed-dose combination:

• Loratadine 10 mg
• Pseudoephedrine sulfate 240 mg
  Administered as a 24-hour extended-release tablet.

This identity is the anchor for upstream sourcing: any credible supplier program for CLARITIN-D 24 HOUR must supply both drug substances at the correct grades suitable for solid oral ER dosage manufacturing.

What supplier categories should an R&D or investment diligence team map next?

A diligence-grade supplier map for CLARITIN-D 24 HOUR should be built in this order:

1. Labeler and manufacturer of record for the exact NDC and strength (tablet ER)
2. API sources for loratadine and pseudoephedrine sulfate (DMF/CEP-linked where applicable)
3. Critical excipient/ER technology suppliers (binders, release modifiers, coatings)
4. Packaging component vendors (blister or bottle components, if the packaging format is fixed)
5. Contract manufacturing and analytical testing sites for batch release

Why supplier naming matters specifically for ER pseudoephedrine products

ER pseudoephedrine performance is sensitive to:

• ER matrix/excipient chemistry
• particle size and polymorph behavior of active materials
• granulation and compression parameters
  That makes excipient and ER formulation suppliers and the manufacturing site a practical risk axis for supply continuity.

Key Takeaways

• CLARITIN-D 24 HOUR is a loratadine + pseudoephedrine ER fixed-dose tablet; upstream supply must cover both APIs and an ER excipient system.
• A complete, citation-backed list of named suppliers (API makers, excipient vendors, and contract manufacturers) is not available from the information provided here.
• For actionable supplier identification, the correct approach is to map manufacturer of record by NDC first, then trace upstream API and excipient qualification from regulatory filings and label disclosures.

FAQs

1. Who is the brand owner for CLARITIN-D 24 HOUR in the US?
   The product is marketed under the Schering-Plough brand family with ownership aligned to Bristol Myers Squibb.

2. What are the two active ingredients in CLARITIN-D 24 HOUR?
   Loratadine and pseudoephedrine sulfate.

3. What dosing form drives the supplier requirements?
   The product is a 24-hour extended-release tablet, so ER excipient and process compatibility are critical.

4. Does the drug’s combination format change API sourcing?
   Yes. It requires qualified sourcing for both APIs (loratadine and pseudoephedrine) and compatibility with ER formulation requirements.

5. Can we list specific API and excipient suppliers from the information here?
   No. Named supplier lists for the specific product cannot be produced without the label/filing records that identify manufacturer and upstream sources.

References (APA)

[1] U.S. Food and Drug Administration. (n.d.). Drugs@FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
[2] DailyMed. (n.d.). Loratadine and Pseudoephedrine Extended-Release Tablets, USP (CLARITIN-D 24 HOUR). https://dailymed.nlm.nih.gov/
[3] U.S. Food and Drug Administration. (n.d.). Structured Product Labeling (SPL) via DailyMed and FDA sources. https://dailymed.nlm.nih.gov/