Suppliers and packagers for peridex

peridex

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
3m	PERIDEX	chlorhexidine gluconate	SOLUTION;DENTAL	019028	NDA	Solventum US LLC	48878-0620-1	473 mL in 1 BOTTLE (48878-0620-1)	1986-08-13
3m	PERIDEX	chlorhexidine gluconate	SOLUTION;DENTAL	019028	NDA	Solventum US LLC	48878-0620-2	1893 mL in 1 BOTTLE, DISPENSING (48878-0620-2)	1986-08-13
3m	PERIDEX	chlorhexidine gluconate	SOLUTION;DENTAL	019028	NDA	Solventum US LLC	48878-0620-3	118 mL in 1 BOTTLE (48878-0620-3)	1986-08-13

Suppliers and packagers for peridex

Last updated: May 27, 2026

PERIDEX (chlorhexidine gluconate) suppliers: Who makes the drug substance and finished dosage for oral antisepsis?

Executive summary: PERIDEX is chlorhexidine gluconate oral solution used as an antiseptic in periodontal and gingival conditions. The supply chain is split between (1) the chlorhexidine gluconate active ingredient manufacturer(s) and (2) finished-dose manufacturers that produce the oral rinse marketed as PERIDEX. Without the product’s label-holder list and Orange Book/NDAspecific supplier disclosures for the exact dosage strength and package, a complete, accurate supplier mapping cannot be produced.

What companies supply PERIDEX (chlorhexidine gluconate oral rinse) in the US?

Featured snippet answer: PERIDEX supply is governed by the NDA holder’s contracted manufacturers for (a) drug substance and (b) finished oral solution. These suppliers can be identified from Orange Book “Applicant” listings tied to the approved NDA and the listed manufacturers for each product/strength.

Who manufactures the chlorhexidine gluconate API used for PERIDEX?

Featured snippet answer: Chlorhexidine gluconate API is manufactured by specialty chemical producers under commercial contract manufacturing for pharmaceutical intermediates. PERIDEX-specific API supplier names depend on the NDA holder’s sourcing disclosures and Orange Book listing of the manufacturing site(s) tied to the approved application.

Are API suppliers listed on the Orange Book for PERIDEX?

Orange Book typically lists:

• Applicant/NDA holder
• Patent/Exclusivity links
• Sometimes manufacturing site information for dosage form, depending on the record and product type
  It does not always provide a direct “API supplier” name separate from drug substance procurement.

Which regulatory filings identify API vendors for PERIDEX?

Manufacturing and site information for the finished drug can be reflected in:

• FDA Drug Registration and Listing (DRLM) records
• NDA chemistry manufacturing controls (CMC) in the approval package
• Label sections that list manufacturer/packer/distributor
  API vendor names often require CMC detail and are not consistently public.

Which finished-dose manufacturers produce PERIDEX oral solution?

Featured snippet answer: The finished product is produced by contract manufacturers or the NDA holder’s sites under GMP. Public evidence is usually found in:

• US label “Manufactured for” sections
• FDA DRLM records for the specific NDC(s)
• Orange Book manufacturing site lines tied to the dosage form

How to match PERIDEX suppliers by NDC

PERIDEX is distributed in specific NDC configurations tied to strength and packaging. Supplier identification must be NDC-specific because different packagers or fillers can be used across:

• Bottle size
• Strength (e.g., 0.12%)
• Labeler/packer assignment

What is the Orange Book status of PERIDEX and how does it affect who can supply it?

Featured snippet answer: The Orange Book status determines patent and exclusivity timelines that limit generic entry. Supplier availability for new formulations or manufacturers depends on whether generics are approved and whether patent challenges have occurred.

Does PERIDEX have generic or AB-rated equivalents?

If AB-rated generics exist for chlorhexidine gluconate oral rinse, supply is broadened through:

• Multiple ANDAs (different applicants and manufacturing sites)
• Multiple NDC labelers
  If PERIDEX’s route is only through the reference product, supply is narrower and concentrated around the reference manufacturer’s network.

How do Paragraph IV challenges change the supplier market?

Paragraph IV filings can:

• Trigger litigation and settlements that carve out timing
• Affect which generic applicants receive market authorization first
  That in turn affects which manufacturers are active in the supply chain at launch.

Which suppliers can sell PERIDEX internationally if US supply is constrained?

Featured snippet answer: International sales depend on jurisdiction-specific approvals and local label/MAH arrangements. Multiple producers may exist abroad even when US supply is concentrated.

Are there differences in excipient systems that require different manufacturing suppliers?

Yes. Oral antisepsis products vary in:

• Vehicle formulation
• Flavoring and alcohol content
• Concentration and delivery properties
  These changes impact which sites can qualify and maintain GMP release.

What patent estate protects PERIDEX and how does it map to manufacturing suppliers?

Featured snippet answer: The patent estate protects the approved chlorhexidine gluconate oral rinse product, typically covering:

• Composition of matter or formulation
• Method-of-use (clinical use)
• Manufacturing methods (sometimes)
  Supplier freedom depends on the scope and remaining term of these patents for each contested element.

How strong is the patent estate for chlorhexidine gluconate oral rinse (PERIDEX)?

A strength assessment requires:

• Active Orange Book patents for the exact NDA product (strength-specific)
• Listed expiration dates
• Any currently litigated or waived claims
  Without the Orange Book product record for the exact PERIDEX NDC(s), no accurate strength ranking can be stated.

What generic entry risks exist for PERIDEX and what does that mean for suppliers?

Featured snippet answer: Generic entry risks are driven by:

• Patent/exclusivity expiration timing
• Bioequivalence/formulation identity and CMC comparability
  Supplier pipeline expands after authorized ANDA launch and distribution agreements.

Do generics source from the same API suppliers as PERIDEX?

Sometimes yes at the API level, but the final drug product suppliers can differ due to:

• Different fill-finish sites
• Alternative packaging and label compliance
• Different scale and cost structures

How does PERIDEX compare with other chlorhexidine oral rinses when identifying suppliers?

Featured snippet answer: Other branded or private-label chlorhexidine mouth rinses can have distinct NDA/ANDA pathways and thus different manufacturing networks. Supplier lists should be treated as product-NDC-specific, not ingredient-specific.

Do other chlorhexidine brands share the same manufacturing sites?

They can, especially if the same contract manufacturing organization produces multiple rinse SKUs. Site confirmation still requires label/DRLM/NDC evidence.

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Key Takeaways

• PERIDEX supply chain is defined by drug substance (chlorhexidine gluconate API) sourcing and finished oral rinse GMP manufacturing.
• A precise list of named suppliers requires NDC-specific labeler/packer/manufacturer evidence and/or Orange Book/DRLM records tied to PERIDEX’s exact strength and packaging.
• Patent and exclusivity status determine when additional generic suppliers can enter and widen the manufacturing and distribution base.

FAQs

1. What does the PERIDEX label say about “manufactured for” and “distributed by,” and how does that identify the supplier network?
2. How can I map PERIDEX suppliers to an NDC for chlorhexidine gluconate oral solution?
3. Which FDA databases best reveal finished-dose manufacturing sites for PERIDEX (DRLM vs Orange Book)?
4. Do chlorhexidine gluconate generics use the same API suppliers as PERIDEX?
5. If PERIDEX supply is tight, can pharmacists substitute with AB-rated chlorhexidine oral rinses based on NDC and Orange Book listing?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026).
2. FDA. Drug Registration and Listing System (DRLS/DRLM). (Accessed 2026).