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Rugby Polyvinyl Alcohol 1.4% Lubricating Eye Drops 1.4 g/100mL Solution/ Drops — NDC 00536-1408-94 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Rugby Polyvinyl Alcohol 1.4% Lubricating Eye Drops 1.4 g/100mL Solution/ Drops — NDC 0536-1408-94 (Billing 00536-1408-94)

by Rugby Laboratories · 1 BOTTLE, DROPPER in 1 BOX / 15 mL in 1 BOTTLE, DROPPER

This is a package of Rugby Polyvinyl Alcohol 1.4% Lubricating Eye Drops 1.4 g/100mL Solution/ Drops from Rugby Laboratories, marketed since Oct 2023 and currently FDA-listed; retail pharmacies pay about $0.3416 per mL (NADAC). It is this product's only package size.

NDC 00536-1408-94
🏷️ FDA NDC (as labeled) 0536-1408-94 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 0536-1408-94 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0536 labeler · 1408 product · 94 package
Package marketed since
Oct 19, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0305361408947
Medicaid fills, this package
31,598 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Polyvinyl Alcohol (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Apr 23, 2025 — cGMP deviations and lack of assurance of sterility. (BRS Analytical Services, LLC) · FDA recall D-0408-2025
Class III · Dec 18, 2024 — LABELING: LABEL MIX-UP (AvKARE) · FDA recall D-0176-2025
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) 0536-1408-94
Product NDC 0536-1408
11-digit billing NDC 00536140894
NCPDP billing unit ML — per mL (volume)
RxCUI 142004
UNII 532B59J990
UPC 0305361408947
Application # M018
SPL Set ID 081673b2-5c74-1200-e063-6394a90ae363
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-10-19
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance POLYVINYL ALCOHOL, UNSPECIFIED

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 86200050002030
GCN Seq No 007936
GCN 33422
HICL code 005225
Ingredient (HICL) Polyvinyl Alcohol
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q6
Therapeutic class — intermediate (HIC2) Ophthalmic Preparations
HIC3 code Q6T
Therapeutic class — specific (HIC3) Artificial Tears
AHFS code 52:92.00.00
AHFS class Eent Drugs, Miscellaneous
FDB label name POLYVINYL ALCOHOL 1.4% EYEDROP
FDB brand name Polyvinyl Alcohol
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 007936
  • GCN: 33422
  • GPI-14 (Medi-Span): 86200050002030
  • HICL (First Databank): 005225
  • AHFS class code: 52:92.00.00
  • RxCUI (RxNorm): 142004
Why two NDCs? The FDA registers this code as 0536-1408-94 — 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 → 00536-1408-94. 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

Label name POLYVINYL ALCOHOL 1.4% EYEDROP Ingredient Polyvinyl Alcohol
🧪 What is this product?

Rugby Polyvinyl Alcohol 1.4% Lubricating Eye Drops is an over-the-counter eye drop solution marketed under FDA's OTC monograph rules for lubricating products. The active ingredient, polyvinyl alcohol, is a synthetic lubricant commonly used to relieve dry eye discomfort and provide moisture to the eye surface. This product is applied directly to the eye as needed to soothe irritation and help maintain tear film.

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 $0.342 $5.12 / 15 ml
Medicaid paysCMS SDUD · 12 mo $0.7154 $10.73 / 15 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per mL) — tap or hover for the price & month
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $0.352 $0.342
▼ Down 3% over the last 10 months.
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
00536-1408-94 You're viewing this Main listing 1 BOTTLE, DROPPER in 1 BOX / 15 mL in 1 BOTTLE, DROPPER 2023-10-19 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Rugby Polyvinyl Alcohol 1.4% Lubricating Eye Drops 1.4 g/100mLthis 00536-1408-94 Rugby 1 bottle $0.342 — Availability likely —
Polyvinyl Alcohol 14 mg/mL 50268-0678-15 AvPAK 15 ml $0.342 — Availability likely —
Rugby Lubricating Drops 14 mg/mL 50090-5996-00 A-S 15 ml — — FDA listed —
Polyvinyl Alcohol 14 mg/mL 50090-7119-00 A-S 15 ml — — FDA listed —
Rugby Polyvinyl Alcohol 1.4% Lubricating Eye Drops 1.4 g/100mL 50090-7606-00 A-S 1 bottle — — FDA listed —
Vis Guard Lubricant Eye Drops 1.4 mg/100mL 73057-0530-08 Ulai 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

🏛️
2023
On the market since
Oct 2023
📍
2026
Currently FDA-listed
3 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.

💡 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 E1W4N241FO
    A salt compound derived from phosphoric acid and sodium, used as a buffer to help maintain the medication's pH level and as a filler to give the tablet or capsule its proper form and size.
  • UNII 5QWK665956
    A salt derived from phosphoric acid and sodium, used primarily as a buffer to control the acidity or pH of a medication, helping keep it stable during storage and use.
  • 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.

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

The official label also statesbenzalkonium chloride, dibasic sodium phosphate hydrate, disodium edetate hydrate, monobasic sodium phosphate dihydrate, sodium chloride, water for injection.

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

LabelerRugby Laboratories
FDA applicationM018 (OTC MONOGRAPH DRUG)
Labeler code00536
First marketedOct 2023
Product typeHuman Otc Drug
Portfolio149 products on file

More NDCs from Rugby Laboratories labeler code 00536

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 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Other Information 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 36 words ▾

Uses for use as a protectant against further irritation or to relieve dryness of the eye for the temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or sun

⏱️ Dosage and Administration 12 words ▾

Directions instill 1 to 2 drops in the affected eye(s) as needed

⚠️ Warnings 100 words ▾

Warnings For external use only Do not use this product if solution changes color or becomes cloudy When using this product remove contact lenses before using to avoid contamination, do not touch tip of container to any surface replace cap after using. Keep container tightly closed. Stop use and ask a doctor if you experience eye pain changes in vision continued redness or irritation of the eye or if the condition worsens or persists for more than 72 hours Keep out of the reach of children.

If accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

🧪 Active Ingredient 5 words ▾

Active ingredient Polyvinyl alcohol 1.4%

🧪 Inactive Ingredients 20 words ▾

Inactive ingredients benzalkonium chloride, dibasic sodium phosphate hydrate, disodium edetate hydrate, monobasic sodium phosphate dihydrate, sodium chloride, water for injection.

🎯 Purpose 2 words ▾

Purpose Lubricant

📄 Do Not Use 12 words ▾

Do not use this product if solution changes color or becomes cloudy

📄 When Using This Product 29 words ▾

When using this product remove contact lenses before using to avoid contamination, do not touch tip of container to any surface replace cap after using. Keep container tightly closed.

📄 Stop Use and Ask a Doctor If 33 words ▾

Stop use and ask a doctor if you experience eye pain changes in vision continued redness or irritation of the eye or if the condition worsens or persists for more than 72 hours

📄 Keep Out of Reach of Children 21 words ▾

Keep out of the reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

📄 Other Information 19 words ▾

Other information keep in a dry place store at 15°-25°C (59°-77°F) store away from sources of heat or ignition

📄 Package Label / Principal Display Panel 16 words ▾

Rugby Polyvinyl Alcohol 1.4% Lubricating Eye Drops 15mL Rugby Polyvinyl Alcohol 1.4% Lubricating Eye Drops 15mL

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
31.6K
Units reimbursed last 4 qtrs
494.1K
Gross reimbursed last 4 qtrs
$353.5K
Avg / prescription
$11.19
Avg / unit
$0.7154
Latest quarter Q1 2026
9.1KRx
Medicaid pays / mL
$0.7154
gross reimbursed
vs
NADAC / mL
$0.3416
acquisition cost
=
Spread
+$0.3738
+109% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
41% FFS 59% MCO
Fee-for-service · 12,861 Rx Managed care · 18,737 Rx
State Medicaid map
Alaska: no data reported AK Maine: 1,650 units · 118 per 100k residents ME Washington: 17,310 units · 222 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 44,981 units · 784 per 100k residents MN Wisconsin: 19,046 units · 322 per 100k residents WI Michigan: 34,805 units · 347 per 100k residents MI New York: 500 units · 2.6 per 100k residents NY Vermont: 180 units · 27.8 per 100k residents VT New Hampshire: 195 units · 13.9 per 100k residents NH Oregon: 750 units · 17.7 per 100k residents OR Nevada: 840 units · 26.3 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 990 units · 30.9 per 100k residents IA Illinois: 31,595 units · 252 per 100k residents IL Indiana: 17,941 units · 261 per 100k residents IN Ohio: 35,910 units · 305 per 100k residents OH Pennsylvania: 30,495 units · 235 per 100k residents PA New Jersey: 45,619 units · 491 per 100k residents NJ Massachusetts: 121,805 units · 1,740 per 100k residents MA California: 6,741 units · 17.3 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: 8,250 units · 417 per 100k residents NE Missouri: 23,685 units · 382 per 100k residents MO Kentucky: 15,879 units · 351 per 100k residents KY West Virginia: no data reported WV Virginia: 3,180 units · 36.5 per 100k residents VA Maryland: 1,080 units · 17.5 per 100k residents MD Connecticut: 870 units · 24.1 per 100k residents CT Rhode Island: 12,540 units · 1,145 per 100k residents RI Arizona: 1,725 units · 23.2 per 100k residents AZ New Mexico: 1,245 units · 58.9 per 100k residents NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: 345 units · 6.4 per 100k residents SC Delaware: 660 units · 64.0 per 100k residents DE Oklahoma: no data reported OK Louisiana: 205 units · 4.5 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: 907 units · 134 per 100k residents DC Hawaii: 6,615 units · 461 per 100k residents HI Texas: 5,550 units · 18.2 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
2.61,740
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Massachusetts 1,740 /100k
2 Rhode Island 1,145 /100k
3 Minnesota 784 /100k
4 New Jersey 491 /100k
5 Hawaii 461 /100k
6 Nebraska 417 /100k
7 Missouri 382 /100k
8 Kentucky 351 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.
← 00536-1407-95 · Rugby 00536-1411-07 · Rugby →
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.