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Eyes Alive Eye Wash Water 980 mg/mL Solution, 474 mL — NDC 83291-0230-16 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Eyes Alive Eye Wash Water 980 mg/mL Solution, 474 mL — NDC 83291-230-16 (Billing 83291-0230-16)

by RIVIERA PHARMA INC · 474 mL in 1 BOTTLE

This is a package of 474 mL of Eyes Alive Eye Wash Water 980 mg/mL Solution from RIVIERA PHARMA INC, marketed since May 2024 and currently FDA-listed.

NDC 83291-0230-16
🏷️ FDA NDC (as labeled) 83291-230-16 billing pads the product segment with a zero
This package
Contains474 mL Pack sizes4 compare ↓
Product page 83291-0230-01 Also comes in: 30 ml 83291-230-01 118 ml 83291-230-04 946 ml 83291-230-32
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

NDC database record

One package, one record: these facts belong to NDC 83291-230-16 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
83291 labeler · 230 product · 16 package
Package marketed since
May 31, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0383291000097
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Water (different manufacturers) — 3 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Apr 2, 2026 — Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed. (B BRAUN MEDICAL INC) · FDA recall D-0495-2026
Class II · Dec 22, 2025 — Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution (Baxter Healthcare Corporation) · FDA recall D-0296-2026
Class II · Aug 26, 2025 — Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment. (B BRAUN MEDICAL INC) · FDA recall D-0652-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 83291-230-16
Product NDC 83291-230
11-digit billing NDC 83291023016
RxCUI 1053148
UNII 059QF0KO0R
UPC 0383291000097
Application # M018
SPL Set ID 081079f4-1c06-4054-b771-00fedaa666f6
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-05-31
Route OPHTHALMIC
Dosage form SOLUTION
Substance WATER
Quick answers
  • RxCUI (RxNorm): 1053148
Why two NDCs? The FDA registers this code as 83291-230-16 — 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 → 83291-0230-16. 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.

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.

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: 30 ml 118 ml 946 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
83291-0230-01 83291-230-01 Main listing 30 mL in 1 BOTTLE 2024-05-31 — Active
83291-0230-04 83291-230-04 118 mL in 1 BOTTLE 2024-05-31 — Active
83291-0230-16 You're viewing this 474 mL in 1 BOTTLE 2024-05-31 — Active
83291-0230-32 83291-230-32 946 mL in 1 BOTTLE 2024-05-31 — Active

You're viewing one of 4 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This package contains 474 mL — 474 ml in 1 bottle.
How does this package differ from NDC 83291-0230-01?
Both are Eyes Alive Eye Wash Water 980 mg/mL Solution — the drug itself is identical. This page's package is the 474 mL one, while NDC 83291-0230-01 is the 30 ml package.
What NDC number is used to bill for this package of Eyes Alive Eye Wash Water 980 mg/mL Solution?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Eyes Alive Eye Wash 980 mg/mLthis 83291-0230-16 RIVIERA 474 ml — — 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

🏛️
2024
On the market since
May 2024
📍
2026
Currently FDA-listed
2 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.

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.

🧪 Avoiding an ingredient? See Water inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 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 70WT22SF4B
    A mineral salt that acts as a buffer to maintain the pH balance of the medication. It helps stabilize the drug's potency and prevents unwanted chemical changes during storage.
  • 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 dihydrate, sodium chloride, sodium phosphate dibasic heptahydrate, sodium phosphate monobasic monohydrate.

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.

Manufacturer & labeler

LabelerRIVIERA PHARMA INC
FDA applicationM018 (OTC MONOGRAPH DRUG)
Labeler code83291
First marketedMay 2024
Product typeHuman Otc Drug
Portfolio2 products on file

More NDCs from RIVIERA PHARMA INC labeler code 83291

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.

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 📄 Do Not Use 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 27 words ▾

Uses For flushing the eye to help relieve irritation, discomfort, burning, stinging or itching by removing loose foreign material, air pollutants (smog or pollen) or chlorinated water.

⏱️ Dosage and Administration 26 words ▾

Directions Flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle Do not touch bottle tip to eye

⚠️ Warnings 104 words ▾

Warnings For external use only To avoid contamination, do not touch tip of bottle to any surface Do not reuse Once opened, discard Do not use If solution changes colors or becomes cloudy With contact lenses If bottle is opened or seal is broken Stop use and consult a doctor if you experience Eye pain Changes in vision Continued redness or irritation of the eye or if the condition worsen or persists. Obtain immediate medical treatment for all open wounds in or near the eyes. Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 35 words ▾

Other Information Tamper-evident cap: Do not use if twist off top is broken or missing Twist cap to open Use before expiration date marked on bottle Store at room temperature, 15°-30° C (59° to 86°F).

🧪 Active Ingredient 5 words ▾

Active Ingredient Purified Water 98%

🧪 Inactive Ingredients 17 words ▾

Inactive Ingredients Benzalkonium chloride, edetate disodium dihydrate, sodium chloride, sodium phosphate dibasic heptahydrate, sodium phosphate monobasic monohydrate.

🎯 Purpose 2 words ▾

Purpose Eyewash

📄 Do Not Use 21 words ▾

Do not use If solution changes colors or becomes cloudy With contact lenses If bottle is opened or seal is broken

📄 Stop Use and Ask a Doctor If 41 words ▾

Stop use and consult a doctor if you experience Eye pain Changes in vision Continued redness or irritation of the eye or if the condition worsen or persists. Obtain immediate medical treatment for all open wounds in or near the eyes.

📄 Keep Out of Reach of Children 19 words ▾

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

📄 Questions or Comments 11 words ▾

Questions or Comments? Call 800.477.2884, M-F 9 am-5 pm Eastern time

📄 Package Label / Principal Display Panel 51 words ▾

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label EYE WASH NDC# 83291-230-04 Eyes Alive ™ Eye Wash Sterile Buffered Isotonic Solution Single Use Item # RPI-233 Mfd. For: Riviera Pharma, Inc. Sunrise, FL 33325 www.rivierapi.com 4 fl.oz. (118 mL) MADE IN THE USA PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 RIVIERA PHARMA 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 3 other package presentations of this same product, including 30 ml (83291-0230-01), 118 ml (83291-0230-04), 946 ml (83291-0230-32). 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?
RIVIERA PHARMA 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.
← 83291-0200-00 · RIVIERA 83294-0101-18 · CLEURE →
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.