Visine Red Eye Comfort Tetrahydrozoline Hydrochloride .5 mg/mL Solution/ Drops
by Kenvue Brands LLC · 1 BOTTLE, DROPPER in 1 CARTON (69968-0355-1) / 15 mL in 1 BOTTLE, DROPPER
NDC 69968-0355-01
🏷️ FDA NDC (as labeled)
69968-0355-1
billing pads the package segment with a zero
OTC
On market
Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
🆔 Identity & classification
FDA NDC (as labeled)
69968-0355-1
Product NDC
69968-0355
11-digit billing NDC
69968035501
NCPDP billing unit
ML — per mL (volume)
UNII
0YZT43HS7D
Application #
M018
SPL Set ID
d7abd7cb-e094-481f-bea5-a5983e2c9ef4
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
TETRAHYDROZOLINE HYDROCHLORIDE
Why two NDCs?
The FDA registers this code as 69968-0355-1 — 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 → 69968-0355-01. 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.
🏷️ RxNorm drug class
This medicine belongs to the Sympathomimetics, plain class.
Drug family (ATC)
Sympathomimetics, plain, Sympathomimetics used as decongestants
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.
🏭 Manufacturer & labeler
LabelerKenvue Brands LLC
FDA applicationM018 (OTC MONOGRAPH DRUG)
Labeler code69968
First marketedApr 2020
Product typeHuman Otc Drug
Portfolio564 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 it is MedlinePlus · NLM
Ophthalmic tetrahydrozoline is used to relieve minor eye irritation and redness caused by colds, pollen, and swimming.
Read the full MedlinePlus article ↗📗 Our plain-language guide HelloPharmacist
- It relieves the redness you see, but it doesn't treat the underlying cause of the irritation. Think of it as a short-term fix to take the red out. If something is genuinely botheri...
- What exactly does this eye drop do — does it actually fix what's irritating my eye?
- No — you should remove your contact lenses before putting in the drops. The solution can be absorbed by soft contacts, which can affect the lens and potentially irritate your eye....
- Can I wear my contact lenses while using these drops?
Patient education
Supplement & herbal interactions
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.
💬 Questions about Tetrahydrozoline Hydrochloride?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII PQ6CK8PD0R
Ascorbic acid, also known as vitamin C, is a white crystalline powder. It serves as an antioxidant to prevent degradation of other ingredients and may also function as a preservative in the formulation.
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UNII R57ZHV85D4
Boric acid is a weak acid derived from boron. In medicines, it typically serves as a buffer to help maintain the product's pH level and may act as a preservative in certain formulations.
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UNII IY9XDZ35W2
Dextrose is a simple sugar derived from corn or other sources. It serves as a filler and sweetener in medicines to add bulk, improve taste, and help stabilize the medication's form.
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UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
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UNII TE7660XO1C
Glycine is an amino acid used in medicines as a buffer to help stabilize pH and improve taste. It may also serve as a filler or binder to give the product proper form and consistency.
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UNII 02F3473H9O
A mineral salt used in medications as a source of magnesium. It helps bind ingredients together, improve texture, and maintain the product's stability during storage.
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UNII RNW5AM67C0
Polixetonium chloride is a synthetic polymer used in medications as a binder and film-former. It helps hold tablet ingredients together and can create protective coatings on solid dosage forms.
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UNII 660YQ98I10
Potassium chloride is a mineral salt used in medicines as a buffer and to help maintain the proper pH balance and stability of the formulation during storage and use.
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UNII 91MBZ8H3QO
Sodium borate is an inorganic salt compound used in medicines as a buffer to help maintain a stable pH level, and sometimes as a mild preservative or cleansing agent in topical formulations.
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UNII 1Q73Q2JULR
Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
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UNII TU7HW0W0QT
A salt derived from lactic acid, sodium lactate acts as a buffer and pH stabilizer in medicines. It helps maintain the product's acidity level and can also serve as a humectant to retain moisture.
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UNII 22ADO53M6F
A mineral salt derived from phosphoric acid, used as a buffer to maintain the pH balance of the medication and help stabilize the active ingredients.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
13 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesascorbic acid, boric acid, dextrose, glycerin, glycine, magnesium chloride, polyquaternium-42, potassium chloride, purified water, sodium borate, sodium citrate, sodium lactate, sodium phosphate dibasic
Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.
Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed —
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.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 system | Per mL | Per 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.
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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Good Neighbor Pharmacy Eye Drops Original Formula .05 g/100mL 24385-0075-05 | AmerisourceBergen | 1 bottle | $0.097 | — | Discontinued | — |
| Foster and Thrive Original Formula Eye Drops .05 g/100mL 70677-1159-01 | Strategic | 1 bottle | $0.097 | — | Availability likely | — |
| Quality Choice Eye Drops Redness Relief .05 g/100mL 83324-0340-15 | Chain | 1 bottle | $0.097 | — | Availability likely | — |
| Sunmark Eye Drops Original Formula .05 g/100mL 49348-0037-29 | Strategic | 1 bottle | $0.115 | — | FDA listed | — |
| Walgreens Eye Drops Original 15mL and twin pack .05 g/100mL 00363-4550-01 | Walgreens | 1 bottle | — | — | FDA listed | — |
| Kroger Eye Drops Original .05 g/100mL 30142-0574-01 | The | 1 bottle | — | — | FDA listed | — |
| TopCare Health Original Eye Drops .05 g/100mL 36800-0858-01 | Topco | 1 bottle | — | — | FDA listed | — |
| HEB Original Eye Drops .05 g/100mL 37808-0577-01 | HEB | 1 bottle | — | — | FDA listed | — |
| Meijer Redness Relief .05 g/100mL 41250-0814-01 | Meijer | 1 bottle | — | — | FDA listed | — |
| GoodSense Eye Drops Original Formula .05 g/100mL 50804-0141-01 | Geiss, | 1 bottle | — | — | FDA listed | — |
| CAREALL Eyedrops Original .5 mg/mL 51824-0039-05 | New | 15 ml | — | — | FDA listed | — |
| Discount Drug Mart Eye Drops Original .05 g/100mL 53943-0073-01 | Discount | 1 bottle | — | — | FDA listed | — |
| Family Wellness Original Redness Relief Eye Drops .05 g/100mL 55319-0907-01 | Family | 1 bottle | — | — | FDA listed | — |
| Medics Choice Eye Drops Original Redness Reliever .5 mg/mL 55651-0005-01 | KC | 1 bottle | — | — | FDA listed | — |
| Original Redness Reliever .05 g/100mL 55651-0063-01 | KC | 1 bottle | — | — | FDA listed | — |
| DG Original Eye Drops .05 g/100mL 55910-0363-01 | Dolgencorp | 1 bottle | — | — | FDA listed | — |
| CVP Sterile Eye Drops .05 g/100mL 57243-0068-01 | Salado | 1 bottle | — | — | FDA listed | — |
| Preferred Plus Pharmacy Redness Relief Eye Drops .05 g/100mL 61715-0212-01 | Kinray | 1 bottle | — | — | FDA listed | — |
| Best Choice Eye Drops Original .05 g/100mL 63941-0139-01 | Valu | 1 bottle | — | — | FDA listed | — |
| Redness Reliever, Circle K .5 mg/mL 66715-5429-04 | Lil' | 1 bottle | — | — | FDA listed | — |
| Lil Drug Store Eye Drops Redness Reliever .5 mg/mL 66715-6832-04 | Lil | 1 bottle | — | — | FDA listed | — |
| CIRCLE K sterile eye drops .05 g/100mL 66715-8882-01 | Lil' | 1 bottle | — | — | FDA listed | — |
| Lil Drug Store Sterile Eye Drops Redness Reliever .05 g/100mL 66715-8883-01 | Lil' | 1 bottle | — | — | FDA listed | — |
| Winco Original Formula Eye Drops .05 g/100mL 67091-0310-15 | WinCo | 1 bottle | — | — | FDA listed | — |
| Equate Eye Drops .5 mg/mL 67172-0281-01 | Prestige | 1 bottle | — | — | FDA listed | — |
| Equate Eye Drops .5 mg/mL 67172-0282-01 | Prestige | 1 bottle | — | — | FDA listed | — |
| Harris Teeter Eye Drops Original .05 g/100mL 69256-0977-01 | Harris | 1 bottle | — | — | FDA listed | — |
| Visine Red Eye Comfort .5 mg/mLthis 69968-0355-01 | Kenvue | 1 bottle | — | — | FDA listed | — |
| Equate Original Eye Drops .05 g/100mL 79903-0158-05 | Walmart, | 1 bottle | — | — | FDA listed | — |
| Original Redness Reliever .05 g/100mL 79903-0363-01 | Walmart | 1 bottle | — | — | FDA listed | — |
| Equaline Sterile Eye Drops .05 g/100mL 83455-0210-01 | United | 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 Red Eye Comfort (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 58%
Female · 42%
Unknown · 1%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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 NDC | Description | Marketing start | Status |
|---|---|---|---|
| 69968-0355-01 You're viewing this | 1 BOTTLE, DROPPER in 1 CARTON (69968-0355-1) / 15 mL in 1 BOTTLE, DROPPER | 2020-04-27 | Active |
🧭 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) | ✓ 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 69968-0355-1, 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: 69968-0355-01, written without dashes as 69968035501. 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 69968-0355-01, the first segment (69968) is the labeler code FDA assigned to Kenvue Brands LLC; the middle segment (0355) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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.
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 ▾
Use for the relief of redness of the eye due to minor eye irritations
⏱️ Dosage and Administration ▾
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
⚠️ Warnings ▾
Warnings For external use only Ask a doctor before use if you have narrow angle glaucoma. When using this product 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.
📦 Storage and Handling ▾
Other information Store at 20° to 25°C (68° to 77°F)
🧪 Active Ingredient ▾
Active ingredient Tetrahydrozoline HCl 0.05%
🧪 Inactive Ingredients ▾
Inactive ingredients ascorbic acid, boric acid, dextrose, glycerin, glycine, magnesium chloride, polyquaternium-42, potassium chloride, purified water, sodium borate, sodium citrate, sodium lactate, sodium phosphate dibasic
🎯 Purpose ▾
Purpose Redness reliever
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.