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Visine Dry Eye Relief Polyethylene Glycol 400 400 10 mg/mL Solution/ Drops — NDC 69968-0363-02 package photo

Visine Dry Eye Relief Polyethylene Glycol 400 400 10 mg/mL Solution/ Drops

by Kenvue Brands LLC · 2 BOTTLE, DROPPER in 1 CARTON (69968-0363-2) / 15 mL in 1 BOTTLE, DROPPER
NDC 69968-0363-02
🏷️ FDA NDC (as labeled) 69968-0363-2 billing pads the package segment with a zero
This package
Contains15 mL in 1 bottle, dropper Pack sizes2 compare ↓
Also comes in: 15 mL 69968-0363-01
OTC On market Non-controlled
🗂️ Data synced Sep 25, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 69968-0363-2
Product NDC 69968-0363
11-digit billing NDC 69968036302
RxCUI 2360899
UNII B697894SGQ
Application # M018
SPL Set ID 0bc0d6e7-9195-db6b-e063-6294a90aef04
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-04-27
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance POLYETHYLENE GLYCOL 400
Why two NDCs? The FDA registers this code as 69968-0363-2 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 69968-0363-02. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerKenvue Brands LLC
FDA applicationM018 (OTC MONOGRAPH DRUG)
Labeler code69968
First marketedApr 2020
Product typeHuman Otc Drug
Portfolio567 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

🧪 What is this product?

Visine Dry Eye Relief is an over-the-counter eye drop solution containing polyethylene glycol 400, a type of lubricant commonly used to help relieve dry eye symptoms. This product is marketed as an OTC monograph drug, meaning it follows established FDA guidelines for eye lubricants rather than undergoing individual product review. Polyethylene glycol 400 functions as an artificial tear substitute that is typically applied directly to the eye surface to help moisturize and soothe dryness and irritation.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 15 mL
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Foster and Thrive Dry Eye Relief 400 1 g/100mL 70677-1157-01 Strategic 1 bottle $0.169 — Availability likely —
Visine Dry Eye Relief 400 10 mg/mLthis 69968-0363-02 Kenvue 2 bottles — — FDA listed —
Visine Dry Eye Relief Eye Drops 400 10 mg/mL 69968-0364-01 Kenvue 1 bottle — — FDA listed —
Visine Dry Eye Relief 400 10 mg/mL 69968-0365-01 Kenvue 1 bottle — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2020
On the market since
Apr 2020
📍
2026
Currently FDA-listed
6 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Visine Dry Eye Relief (this brand).

Top reported reactions

Incorrect Product Administration Duration1,267
Nausea950
Diarrhoea892
Constipation721
Vomiting641
Incorrect Drug Administration Duration625
Abdominal Pain610

Age at onset

Neonate10
Infant11
Child90
Adolescent48
Adult1,474
Elderly1,022

Reporter sex

12,342 reports
Male · 45%
Female · 55%
Unknown · 0%

Serious outcomes

Hospitalization4,026
Life-threatening695
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 1,746 602
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
69968-0363-01 1 BOTTLE, DROPPER in 1 CARTON (69968-0363-1) / 15 mL in 1 BOTTLE, DROPPER 2020-04-27 Active
69968-0363-02 You're viewing this 2 BOTTLE, DROPPER in 1 CARTON (69968-0363-2) / 15 mL in 1 BOTTLE, DROPPER 2020-04-27 Active

Pack size FAQ

What quantity is in NDC 69968-0363-02?
NDC 69968-0363-02 is listed by the FDA — 2 bottle, dropper in 1 carton / 15 ml in 1 bottle, dropper.
What NDC number is used to bill for this package of Visine Dry Eye Relief Polyethylene Glycol 400 400 10 mg/mL Solution/ Drops?
Bill NDC 69968-0363-02 — the 11-digit billing format is 69968036302. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 69968-0363-2, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 69968-0363-02, written without dashes as 69968036302. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 69968-0363-02, the first segment (69968) is the labeler code FDA assigned to Kenvue Brands LLC; the middle segment (0363) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Kenvue Brands LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 bottle (69968-0363-01). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Kenvue Brands LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 62 words ▾

Uses for the temporary relief of discomfort and redness of the eye due to minor eye irritations relieves dryness of the eye for the temporary relief of burning and irritation due to exposure to wind or sun for protection against further irritation

Uses for the temporary relief of burning and irritation due to dryness of the eye for protection against further irritation

⏱️ Dosage and Administration 78 words ▾

Directions • adults and children 6 years of age and over: put 1 or 2 drops in the affected eye(s) up to 4 times a day • children under 6 years of age: consult a doctor • children under 2 years of age: do not use

Directions • adults and children 6 years of age and over: put 1 or 2 drops in the affected eye(s) as needed • children under 6 years of age: consult a doctor

⚠️ Warnings ~1 min read ▾

Warnings For external use only Ask a doctor before use if you have narrow angle glaucoma. When using this product • some users may experience a brief tingling sensation • pupils may become enlarged temporarily • overuse may cause more eye redness • remove contact lenses before using • do not use if this solution changes color or becomes cloudy • do not touch tip of container to any surface to avoid contamination • replace cap after each use Stop use and ask a doctor if • you feel eye pain • changes in vision occur • redness or irritation of the eye lasts • condition worsens or lasts more than 72 hours If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Warnings For external use only When using this product • remove contact lenses before using • do not use if this solution changes color or becomes cloudy • do not touch tip of container to any surface to avoid contamination • replace cap after each use Stop use and ask a doctor if • you feel eye pain • changes in vision occur • redness or irritation of the eye lasts • condition worsens or lasts more than 72 hours If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 16 words ▾

Other information Store at 20° to 25°C (68° to 77°F)

Other information Store at room temperature

🧪 Active Ingredient 18 words ▾

Active ingredient Polyethylene glycol 400 1% Tetrahydrozoline HCl 0.05% Zinc sulfate 0.25%

Active ingredient Polyethylene glycol 400 1%

🧪 Inactive Ingredients 44 words ▾

Inactive ingredients benzalkonium chloride, boric acid, edetate disodium, glycerin, hypromellose, purified water, sodium chloride, sodium citrate

Inactive ingredients ascorbic acid, benzalkonium chloride, boric acid, dextrose, disodium phosphate, glycerin, glycine, hypromellose, magnesium chloride, potassium chloride, purified water, sodium borate, sodium chloride, sodium citrate, sodium lactate

🎯 Purpose 7 words ▾

Purpose Lubricant Redness reliever Astringent

Purpose Lubricant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 69968-0360-01 · Kenvue 69968-0364-01 · Kenvue →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.