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Eyesaline Eyewash Concentrate Purified Water 92.14 g/100g Liquid, 5301.4935 g — NDC 80716-0300-02 package photo

Eyesaline Eyewash Concentrate Purified Water 92.14 g/100g Liquid, 5301.4935 g

by Protective Industrial Products, Inc. · 5301.4935 g in 1 BOTTLE, PLASTIC (80716-300-02)
NDC 80716-0300-02
🏷️ FDA NDC (as labeled) 80716-300-02 billing pads the product segment with a zero
This package
Contains5301.4935 g Pack sizes2 compare ↓
Also comes in: 2182.9679 g 80716-0300-01
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 →

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) 80716-300-02
Product NDC 80716-300
11-digit billing NDC 80716030002
RxCUI 2704856
UNII 059QF0KO0R
Application # M018
SPL Set ID 558e5926-9027-d3f6-e063-6294a90ab121
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-11-19
Route OPHTHALMIC
Dosage form LIQUID
Substance WATER
Why two NDCs? The FDA registers this code as 80716-300-02 — a 5-3-2 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 product segment → 80716-0300-02. 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

LabelerProtective Industrial Products, Inc.
FDA applicationM018 (OTC MONOGRAPH DRUG)
Labeler code80716
First marketedNov 2025
Product typeHuman Otc Drug
Portfolio5 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

📗 Our plain-language guide HelloPharmacist
  • It can seem a little odd at first. In these products, sterile water plays the essential role of carrying or dissolving the actual active medication — like insulin — so it can be sa...
  • Why is 'water' listed as the active ingredient on my medicine?
  • No — these are very different products that should never be used interchangeably. Sterile Water for Injection is used only as a diluent for other drugs given by needle, and it must...
  • Is Sterile Water for Injection the same as the eye wash or the irrigation product?
📖 Read our full Water guide →

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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII F5UM2KM3W7
    Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • 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.
  • UNII 593YOG76RN
    A salt made from sodium and phosphate that helps regulate acidity and maintain proper pH balance in the medicine. It also acts as a buffer to keep the product stable.

5 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesBenzalkonium chloride, edetate disodium, sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic

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 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: 2182.9679 g
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
Eyesaline Eyewash Concentrate 92.14 g/100g 00498-2502-01 Honeywell 2182.9679 g — — FDA listed —
Eyesaline Eyewash Concentrate 92.14 g/100gthis 80716-0300-02 Protective 5301.4935 g — — 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

🏛️
2025
On the market since
Nov 2025
📍
2026
Currently FDA-listed
1 year 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 Purified Water — the ingredient across all brands.

Top reported reactions

Eye Irritation5
Thrombocytopenia4
Drug Hypersensitivity3
Eye Pain3
Interstitial Lung Disease3
Nausea3
Oesophagitis3

Age at onset

Adult2
Elderly7

Reporter sex

0 reports
Male · 42%
Female · 58%

Serious outcomes

Hospitalization13
Death9
Life-threatening6
Disabling3
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 7 0
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
80716-0300-01 2182.9679 g in 1 BOTTLE, PLASTIC (80716-300-01) 2025-11-19 Active
80716-0300-02 You're viewing this 5301.4935 g in 1 BOTTLE, PLASTIC (80716-300-02) 2025-11-19 Active

Pack size FAQ

What quantity is in NDC 80716-0300-02?
NDC 80716-0300-02 contains 5301.4935 g — 5301.4935 g in 1 bottle, plastic.
What is the difference between NDC 80716-0300-02 and NDC 80716-0300-01?
Both are Eyesaline Eyewash Concentrate Purified Water 92.14 g/100g Liquid — the drug itself is identical. NDC 80716-0300-02 is the 5301.4935 g package, while NDC 80716-0300-01 is the 2182.9679 g package.
What NDC number is used to bill for this package of Eyesaline Eyewash Concentrate Purified Water 92.14 g/100g Liquid?
Bill NDC 80716-0300-02 — the 11-digit billing format is 80716030002. 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) ✓ 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 80716-300-02, 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: 80716-0300-02, written without dashes as 80716030002. 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 80716-0300-02, the first segment (80716) is the labeler code FDA assigned to Protective Industrial Products, Inc.; the middle segment (0300) 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 Protective Industrial Products, Inc.. 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 2182.9679 g (80716-0300-01). 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?
Protective Industrial Products, Inc. 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 15 words ▾

Uses For flushing the eye to remove loose foreign material, air pollutants or chlorinated water

⏱️ Dosage and Administration 122 words ▾

Directions Concentrate must be diluted (1) part concentrate to (10) parts potable water before use • Prepare sufficient quantity of constituted eyewash solution in advance of an emergency. • Mix concentrate with potable water to prepare eyewash solution as follows: • Determine quantity of eyewash solution required • Follow sanitary procedures • Wear protective eyewear and gloves • Pour 1/3 of required amount of potable water into mixing container or eyewash unit • Add 1/3 of required amount of concentrate to water • Agitate or mix thoroughly • Repeat until required amount of solution is prepared • Properly dispose of empty bottle after use. • Do not reuse • Keep bottle upright • Replace solution no longer than (6) months after mixing

⚠️ Warnings 105 words ▾

Warnings For external use only - Obtain immediate medical treatment for all open wounds in or near eyes. To avoid contamination, do not touch tip of container to any surface. Replace cap after use.

Do not use In concentrated form While wearing contact lenses For injection In intraocular sugery Internally if eye is lacerated or object is imbeded if seal is broken Stop use and consult a doctor if you have changes in vision continued redness, irritation or pain, or if the condition worsens or persist Keep Out of Reach of Children If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 5 words ▾

Active Ingredient Purified Water 92.14%

🧪 Inactive Ingredients 14 words ▾

Inactive Ingredients Benzalkonium chloride, edetate disodium, sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic

🎯 Purpose 2 words ▾

Purpose Eyewash

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 80716-0200-01 · Protective 80716-0500-01 · Protective →
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.