Suppliers and packagers for visine

visine

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Kenvue Brands	VISINE	naphazoline hydrochloride; pheniramine maleate	SOLUTION/DROPS;OPHTHALMIC	020485	NDA	Kenvue Brands LLC	69968-0367-1	1 BOTTLE in 1 CARTON (69968-0367-1) / 15 mL in 1 BOTTLE	2019-05-06
Kenvue Brands	VISINE	naphazoline hydrochloride; pheniramine maleate	SOLUTION/DROPS;OPHTHALMIC	020485	NDA	Kenvue Brands LLC	69968-0367-2	2 BOTTLE in 1 CARTON (69968-0367-2) / 15 mL in 1 BOTTLE	2019-05-06

Supplier landscape for Visine (tetrahydrozoline/related eye drops): Who makes it, who supplies it, and what IP/regulatory constraints shape sourcing

Last updated: May 29, 2026

What suppliers provide Visine eye drops (tetrahydrozoline) for manufacturers and retailers?

Visine is a consumer eye-care brand built on topical ophthalmic actives that include tetrahydrozoline (classic “redness relief” line) and, by product line, other actives used in lubricating/comfort drops. In practice, “Visine suppliers” typically breaks into three supply channels: (1) active pharmaceutical ingredient (API) makers, (2) finished-dose ophthalmic drug product (FDF) manufacturers and packagers, and (3) downstream contract logistics/wholesale distributors that move finished goods to mass retail.

API supply: who produces tetrahydrozoline and other Visine actives

For tetrahydrozoline-based ophthalmics, supply commonly originates from API producers in China and India and then flows to US/EMEA formulators or repackagers. Names of specific suppliers depend on the specific Visine SKU because:

• the “Redness Relief” (tetrahydrozoline) SKU uses a specific API and strength
• the “Dry Eye”/lubricating SKU uses different actives (often demulcents/viscosity agents rather than tetrahydrozoline)

Drug product supply: who manufactures the finished ophthalmic solution

Finished ophthalmic solutions require sterile or controlled-quality liquid manufacture, container-closure compatibility (typically LDPE/PE dropper bottles or unit-dose vials depending on SKU), and ocular-grade excipients. Supply is commonly handled by:

• US FDA-registered manufacturers for the finished dosage form
• contract manufacturers/packagers that fill, finish, label, and distribute

Wholesale/distribution: who supplies retailers

US retail distribution of Visine-branded product is routed through national wholesalers plus store-brand supply chains in certain channels. “Supplier” in this context usually means:

• wholesalers supplying big-box retail
• co-packers that support seasonal promotions and regional demand surges

Which companies are key manufacturers for Visine eye drops (finished dosage product)?

A reliable mapping of “which companies manufacture Visine” requires SKU-by-SKU alignment to the FDA Labeler Code and Orange Book/Drug Listing records for the specific strength and dosage form. That mapping is not possible from the request alone because Visine includes multiple products and actives across OTC lines.

What is the FDA regulatory status of Visine (OTC) and how does that affect supplier selection?

Visine eye drops are sold over-the-counter, and the regulatory pathway is governed by OTC monograph compliance or approved NDAs for certain formulations (depending on the active/claims/strength). From a supplier standpoint, regulatory status determines whether a vendor must:

• hold rights for a marketed NDA/ANDA (for Rx or approved formulations)
• comply with OTC monograph labeling requirements (for classic OTC actives)
• meet current good manufacturing practice (cGMP) and sterile/ophthalmic quality standards

How supplier qualification works in ophthalmics

Ophthalmic product supply tends to require:

• audit readiness for aseptic and particulate/sterility or bioburden expectations (depending on sterile category)
• container-closure and preservative system validation (for multi-dose bottles)
• stability and compatibility data for the specific dropper/bottle format

What patents or exclusivity affect Visine eye drops sourcing and generics?

Visine is primarily an OTC brand using long-established actives such as tetrahydrozoline, which generally means:

• product is not typically protected by strong, long-running exclusivity in the way newer prescription biologics are
• brand differentiation depends more on formulation details, packaging, and OTC labeling than on active ingredient novelty

However, the supplier landscape is shaped by formulation and packaging IP that can still be relevant to:

• preservative systems and excipient packages
• unit-dose vs multi-dose formats
• method-of-manufacture or stability-related patents, where applicable

Without the exact Visine SKU(s) (active, strength, dosage form), the patent estate cannot be enumerated accurately.

Where do Visine suppliers source APIs from (China vs India vs US)?

Without SKU-level detail and manufacturer/labeler mapping, a quantified source-country breakdown would be speculation. In ophthalmic OTC markets generally, tetrahydrozoline supply often has strong non-US manufacturing footprints, but supplier selection for brand owners depends on:

• DMF/ASMF availability tied to the specific strength and excipient recipe
• ability to meet US release specs for particle count, pH, preservative concentration, and stability
• reliability of packaging component supply (dropper systems, bottle resins, seals)

What finished-dose manufacturing constraints make ophthalmic supply bottleneck-prone?

Ophthalmic drops are bottleneck-prone when:

• preservatives and chelating agents have constrained global sourcing
• packaging components (bottle and dropper assemblies) have long lead times
• quality hold issues arise from particulate limits, sterility/bioburden excursions, or viscosity/pH drift

These constraints drive supplier concentration, which is why brand owners often qualify multiple FDF partners and multiple packaging vendors.

What generic entry risks exist for Visine and how does that affect supplier pricing?

Because Visine is OTC and commonly uses established actives, “generic entry” usually means:

• private label and labeler-code variants of tetrahydrozoline and competing lubricating solutions
• store-brand versions that compete on price while remaining therapeutically equivalent

Supplier pricing is affected by:

• API price cycles for tetrahydrozoline and excipients
• capacity in ophthalmic contract manufacturing and filling lines
• packaging component availability

How many suppliers can realistically support Visine volume in the US?

The number depends on the number of SKUs and the complexity of packaging. A single active-strength product may be supported by several FDF manufacturers globally, but US retail distribution concentrates supply among a smaller set of labelers and packagers once quality systems, labeling, and release testing are locked.

Key Takeaways

• “Visine suppliers” should be treated as a supply chain of API providers, ophthalmic finished-dose manufacturers/packagers, and wholesale distributors, not a single vendor list.
• The Visine portfolio includes multiple OTC ophthalmic products, so supplier identification must be SKU-specific to match the correct active, strength, dosage form, labeler code, and regulatory listing.
• In ophthalmics, supplier choice is constrained by ophthalmic cGMP capability, container-closure compatibility, and release testing requirements, which can concentrate supply into a limited set of qualified FDF partners.

FAQs

1. Who makes tetrahydrozoline API for US ophthalmic markets?
2. How do I identify the Visine labeler code for a specific bottle/strength?
3. What OTC regulatory requirements apply to redness-relief eye drops with tetrahydrozoline?
4. What packaging formats are most common for multi-dose Visine-like ophthalmic solutions and why do they matter for supply?
5. How do quality excursions in ophthalmic filling affect brand availability and retailer lead times?

References

No sources were provided in the request, and no SKU- or labeler-specific FDA records were supplied.