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Fendall 2000 Pure Flow Purified water 98.6 L/100L Liquid, 29.9 l — NDC 00498-0631-37 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Fendall 2000 Pure Flow Purified water 98.6 L/100L Liquid, 29.9 l — NDC 0498-0631-37 (Billing 00498-0631-37)

by Honeywell Safety Products USA, Inc. · 29.9 L in 1 CONTAINER

This is a package of 29.9 l of Fendall 2000 Pure Flow Purified water 98.6 L/100L Liquid from Honeywell Safety Products USA, Inc., marketed since Dec 2018 and currently FDA-listed. It is this product's only package size.

NDC 00498-0631-37
🏷️ FDA NDC (as labeled) 0498-0631-37 billing pads the labeler segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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 0498-0631-37 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0498 labeler · 0631 product · 37 package
Package marketed since
Dec 1, 2020
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 0498063137 8
FDA record last changed
Jul 24, 2026
Past resolved recalls for this product (1)
Class II · Mar 29, 2024 · Terminated — CGMP Deviations (HONEYWELL INC) · FDA recall D-0461-2024

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0498-0631-37
Product NDC 0498-0631
11-digit billing NDC 00498063137
RxCUI 1053173
UNII 059QF0KO0R
Application # M018
SPL Set ID b56ef662-fec2-4d94-e053-2995a90aba2b
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-12-15
Route OPHTHALMIC
Dosage form LIQUID
Substance WATER
Quick answers
  • RxCUI (RxNorm): 1053173
Why two NDCs? The FDA registers this code as 0498-0631-37 — a 4-4-2 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 labeler segment → 00498-0631-37. 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.
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
00498-0631-37 You're viewing this Main listing 29.9 L in 1 CONTAINER 2020-12-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Eyesaline Emergency Eyewash 98.6 L/100L 00498-0620-37 Honeywell 3.78 l — — FDA listed —
Eyesaline Emergency Eyewash 98.66 g/100g 00498-0621-01 Honeywell 3819.1001 g — — FDA listed —
Fendall Pure Flow 98.6 L/100L 00498-0630-37 Honeywell 14.38 l — — FDA listed —
Fendall 2000 Pure Flow 98.6 L/100Lthis 00498-0631-37 Honeywell 29.9 l — — 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

🏛️
2018
On the market since
Dec 2018
📍
2026
Currently FDA-listed
8 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 GR686LBA74
    Sodium phosphate, dibasic is a salt derived from phosphoric acid. It acts as a buffer to help maintain the medicine's pH balance and may serve as a binder or filler in tablets and capsules.
  • 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 statesbenzlkonium 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.

Manufacturer & labeler

LabelerHoneywell Safety Products USA, Inc.
FDA applicationM018 (OTC MONOGRAPH DRUG)
Labeler code00498
First marketedDec 2018
Product typeHuman Otc Drug
Portfolio7 products on file

More NDCs from Honeywell Safety Products USA, Inc. labeler code 00498

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 🧪 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 20 words ▾

Uses For flushing or irrigating the eye to reduce chances of severe injury caused by acid, alkali, or particulate contamination

⏱️ Dosage and Administration 33 words ▾

Directions pull handle on the activating door to initiate flow lower head into flow for 15 minutes if necessary, continue flushing with emergency eyewash or shower do not reuse discard cartridge after use

⚠️ Warnings 91 words ▾

Warnings For external use only store at room temperature, 59 o to 86 o F (15 o to 30 o C) do not freeze Do not use if solution changes color or gets cloudy in open wounds in or near the eyes with contact lenses Stop use and ask a doctor if you have changes in vision eye pain continued redness, irritation of the eye or if the condition worsens or persists 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 98.6%

🧪 Inactive Ingredients 14 words ▾

Inactive ingredients benzlkonium chloride, edetate disodium, sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic

🎯 Purpose 3 words ▾

Purpose Emergency Eyewash

📄 Do Not Use 21 words ▾

Do not use if solution changes color or gets cloudy in open wounds in or near the eyes with contact lenses

📄 Stop Use and Ask a Doctor If 27 words ▾

Stop use and ask a doctor if you have changes in vision eye pain continued redness, irritation of the eye or if the condition worsens or persists

📄 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 20 words ▾

Questions? Call 1-800-430-5490 Sperian Eye & Face Protecton, Inc. (a Honeywell Company) 825 East Highway 151 Platteville, WI 53818 USA

📄 Package Label / Principal Display Panel 8 words ▾

Principle Display Panel Fendall 2000 Fendall 2000 PI

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

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 Fendall 2000 Pure Flow (this brand).

Top reported reactions

Interstitial Lung Disease3
Oesophagitis3
Thrombocytopenia3
Depressed Mood2
Drug Hypersensitivity2
Febrile Neutropenia2
Malaise2

Reporter sex

34 reports
Male · 48%
Female · 52%

Serious outcomes

Hospitalization9
Death9
Life-threatening6
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 6 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.

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 Honeywell Safety Products USA, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Honeywell Safety Products USA, 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.
← 00498-0630-37 · Honeywell 00498-0633-01 · Honeywell →
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.