Suppliers and packagers for naphcon-a

naphcon-a

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Alcon	NAPHCON-A	naphazoline hydrochloride; pheniramine maleate	SOLUTION/DROPS;OPHTHALMIC	020226	NDA	Alcon Laboratories, Inc.	0065-0085-15	1 BOTTLE in 1 CARTON (0065-0085-15) / 15 mL in 1 BOTTLE	1994-06-08
Alcon	NAPHCON-A	naphazoline hydrochloride; pheniramine maleate	SOLUTION/DROPS;OPHTHALMIC	020226	NDA	A-S Medication Solutions	50090-0185-0	1 BOTTLE in 1 CARTON (50090-0185-0) / 15 mL in 1 BOTTLE	1994-06-08

Suppliers and packagers for naphcon-a

Last updated: June 1, 2026

NAPHCON-A suppliers: who manufactures, packages, and supplies Naphcon-A (naphazoline hydrochloride/antazoline) in the US and globally

Who are the suppliers of Naphcon-A (naphazoline hydrochloride/antazoline)

Naphcon-A is a multi-source, prescription-free ophthalmic combination product. The “supplier” landscape is typically split across (1) brand-owner marketing entities, (2) FDA-registered finished dose manufacturers that hold marketing authorization in specific NDCs, and (3) labelers that act as distributors/wholesalers for retail and institutional channels.

What is the FDA regulatory status of Naphcon-A and how does it affect supplier availability

Naphcon-A’s availability through US channels is driven by FDA’s OTC ophthalmic framework and Orange Book listing status for any listed patents. For many OTC ophthalmics, the operative supplier map is determined by:

• Whether the product is listed as an approved drug application (NDA) versus marketed under an alternative pathway
• Whether the specific NDCs are held by one labeler or multiple labelers
• Whether manufacturing is outsourced to contract manufacturers (CDMOs) for sterile ophthalmic production and packaging

What patents protect Naphcon-A and do they constrain supplier entry

Patent barriers generally do not block supply for established OTC combinations unless specific formulation or method-of-manufacture patents are enforced for particular strengths or packaging. For combination ophthalmics, any supplier restriction tends to be driven more by manufacturing and labeling control than by hard exclusivity, unless a patent is tied to a specific dosage form/strength and a generic seeks FDA-level “same as” equivalence.

Which companies supply Naphcon-A at the finished-dose (NDC) level

Finished-dose suppliers for Naphcon-A are identified by NDC labeler and manufacturer details on FDA drug listings. In practical terms, the supplier set that matters for procurement is:

• NDC labeler (who lists the product for sale in a specific NDC)
• Applicant/manufacturer (the entity responsible for release of the finished, packaged sterile ophthalmic product)
• Packaging site (primary packager) where it differs from bulk manufacturing

How do you identify the correct Naphcon-A manufacturer for procurement

Procurement accuracy depends on matching:

• Correct active ingredient strengths (naphazoline hydrochloride and antazoline)
• Correct dosage form (ophthalmic solution)
• Correct NDC (pack size, labeler, and formulation)
• Correct trade name and labeling (any “Naphcon-A” label variations)

Without NDC-level mapping to FDA drug listing records, supplier attribution cannot be made at a company-specific level.

What generic or private-label suppliers can provide the same active combination

Because Naphcon-A is an established OTC ophthalmic combination, competition typically comes from:

• Authorized generic and multi-source OTC equivalents
• Private-label distributors using contract manufacturing
• Regional wholesalers sourcing equivalent NDCs

Supplier options are therefore NDC-dependent. The “same actives” does not guarantee the same manufacturing release site, packaging site, or stability specs unless the NDC is matched.

What manufacturing/IP barriers affect who can supply Naphcon-A

The main practical barriers for ophthalmic solutions include:

• Sterile manufacturing capability (aseptic processing and/or sterilization strategy)
• Preservative system control (if applicable to the specific product variant)
• Ophthalmic packaging compatibility (dropper sizing, cap materials, container closure integrity)
• Quality system equivalence (sterility assurance, microbial limits, particle counts)
• FDA cGMP compliance for the specific manufacturing site(s) listed for the relevant NDCs

Naphcon-A vs. other “redness relief” ophthalmics: do suppliers overlap

Supplier overlap is common for ophthalmics because CDMOs produce multiple OTC ophthalmic lines, but labeler-specific and NDC-specific mapping is required to confirm overlap. “Same active ingredients” may still involve different release sites, packaging lines, or labeler QA release.

Key timelines: when can new suppliers enter Naphcon-A channels

For an established OTC product, new supplier entry is primarily limited by:

• Whether an NDC is already covered by existing FDA listings tied to specific manufacturing sites
• Whether formulation changes or packaging changes trigger new submissions or new listing work
• Commercial incentives, not exclusivity, since OTC ophthalmics often have limited remaining IP leverage once products are widely established

Key Takeaways

• “Suppliers for Naphcon-A” must be defined at the NDC level because the manufacturer and labeler can change by pack size and market listing.
• Supplier constraints for Naphcon-A are driven more by sterile ophthalmic manufacturing and FDA cGMP site listings than by exclusivity in most OTC scenarios.
• Any defensible supplier list requires mapping the specific Naphcon-A NDC(s) to FDA drug listing records (labeler and manufacturer details) and cross-referencing procurement-relevant packaging sites.

FAQs

1. How can I confirm the NDC-specific manufacturer for Naphcon-A?
2. Do private-label “Naphcon-A” equivalents use the same manufacturing site as the brand?
3. Which FDA listings determine who can legally sell Naphcon-A in the US?
4. What quality/regulatory factors most affect supply continuity for ophthalmic solutions?
5. How do Naphcon-A supplier options change when switching between pack sizes or labelers?

References (APA)

1. FDA. Drugs@FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
2. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview
3. FDA. NDC Directory. https://www.fda.gov/drugs/drug-approvals-and-databases/ndc-directory