Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
Leader Ultra Lubricating Eye Drops Polyethylene glycol 400, propylene 400 .4 g/100mL; .3 g/100mL Solution/ Drops — NDC 70000-0457-1 (Billing 70000-0457-01)
by Cardinal Health · 1 BOTTLE, DROPPER in 1 BOX / 15 mL in 1 BOTTLE, DROPPER
This is a package of Leader Ultra Lubricating Eye Drops Polyethylene glycol 400, propylene 400 .4 g/100mL; .3 g/100mL Solution/ Drops from Cardinal Health, marketed since Feb 2019 and currently FDA-listed, this package's marketing is listed to end Feb 2027; retail pharmacies pay about $0.3625 per mL (NADAC). It is the main listing for this product, which comes in 2 package sizes.
NDC 70000-0457-01
🏷️ FDA NDC (as labeled)
70000-0457-1
billing pads the package segment with a zero
This package
Contains15 mL in 1 bottle, dropper
Cost per mL$0.3625 NADAC
Per package$5.44 / 15 ml
Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.9504/unit — full pricing hub ↓
Main listing for product 70000-0457 · Also comes in:
2 bottles 70000-0457-2
🗂️ 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 →
NDC database record
One package, one record: these facts belong to NDC 70000-0457-1 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 70000 labeler · 0457 product · 1 package
- Package marketed since
- Feb 19, 2019
- Package marketing ended
- Feb 28, 2027
- Sample package
- No — commercial package
- Barcode (UPC)
- 0096295137101
- Medicaid fills, this package
- 7,970 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
🚨
Active recall for this product.
Class II · Mar 3, 2026 — Lack of Assurance of Sterility (K.C. Pharmaceuticals, Inc) · FDA recall D-0412-2026
Lots / codes: Lot: a) SU24E01, SU24E02, Exp.: 5/31/26; SU24K01, Exp.: 9/30/26; b) SU24E01, Exp.: 5/31/26; c) SU24E01, SU24E02, Exp.: 5/31/26; SU24K01, Exp.: 9/30/26; d) SU24E01, SU24E02, Exp.: 5/31/26; e) SU24E01, SU24E02, Exp.: 5/31/26; SU24K01, Exp.: 9/30/26; f) SU24E01, SU24E02, Exp.: 5/31/26; SU24K01, Exp.: 9/30/26; g) SU24E01, SU24E02, SU24E03, Exp.: 5/31/26; h) SU2… · reported Apr 8, 2026
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
70000-0457-1
Product NDC
70000-0457
11-digit billing NDC
70000045701
NCPDP billing unit
ML — per mL (volume)
RxCUI
477589
UNII
B697894SGQ, 6DC9Q167V3
UPC
0096295137101
Application #
M018
SPL Set ID
d7f011a2-05ba-47c3-9519-d31602e105c7
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2019-02-19
Marketing end
2027-02-28
Route
OPHTHALMIC
Dosage form
SOLUTION/ DROPS
Substance
POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
GPI-14
86209902482020
GPI class
Ultra Lubricating Eye Drops
GCN Seq No
052162
GCN
19719
HICL code
025225
Ingredient (HICL)
Propylene Glycol/Peg 400
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
ULTRA LUBRICANT EYE DROPS
FDB brand name
Ultra Lubricant Eye
Legend status
O — Over-the-counter (OTC) drug or device
Quick answers
- GSN (GCN sequence number): 052162
- GCN: 19719
- GPI-14 (Medi-Span): 86209902482020
- HICL (First Databank): 025225
- AHFS class code: 52:92.00.00
- RxCUI (RxNorm): 477589
Why two NDCs?
The FDA registers this code as 70000-0457-1 — 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 → 70000-0457-01. 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
Clinical
Label name ULTRA LUBRICANT EYE DROPS Ingredient Propylene Glycol/Peg 400
🧪 What is this product?
Leader Ultra Lubricating Eye Drops is an over-the-counter eye drop solution containing polyethylene glycol 400 and propylene glycol. These are lubricating agents typically used to relieve dryness and irritation of the eye surface by providing moisture and a protective film. This product is marketed as an OTC monograph drug, meaning it follows FDA's established safety and effectiveness guidelines for over-the-counter eye lubricants.
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.
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
💬 Questions about Polyethylene glycol 400, propylene glycol?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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 | $0.363 | $5.44 / 15 ml |
| Medicaid paysCMS SDUD · 12 mo | $0.9504 | $14.26 / 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
▲ Up 22% over the last 20 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.
- CMS NADAC weekly file · file of Jun 24, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 70000-0457-01 You're viewing this Main listing | 1 BOTTLE, DROPPER in 1 BOX / 15 mL in 1 BOTTLE, DROPPER | $0.3625 / mL | $5.44 | 2019-02-19 | Feb 28, 2027 | Active |
| 70000-0457-02 70000-0457-2 | 2 BOTTLE, DROPPER in 1 BOX / 15 mL in 1 BOTTLE, DROPPER | — | — | 2019-04-30 | — | Discontinued by firm |
In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in this package?
This package is listed by the FDA — 1 bottle, dropper in 1 box / 15 ml in 1 bottle, dropper.
What NDC number is used to bill for this package of Leader Ultra Lubricating Eye Drops Polyethylene glycol 400, propylene 400 .4 g/100mL; .3 g/100mL Solution/ Drops?
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.
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
Therapeutic equivalents
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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Jun 24, 2026
Availability & generic status
🏛️
2019
On the market since
Feb 2019
📍
2026
Currently FDA-listed
7 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.
- FDA Orange Book · refreshed Oct 3, 2026
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 LU49E6626Q
A synthetic organic compound used as a pH buffer and neutralizing agent in medicines. It helps maintain the proper acidity level in liquid formulations to improve stability and comfort.
-
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 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.
-
UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
-
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.
-
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 506T60A25R
Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
-
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.
8 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesInactive ingredients Aminomethylpropanol, benzalkonium chloride as preservative, boric acid, hypromellose, potassium chloride, purified water, sodium chloride, sorbitol
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.- FDA label on DailyMed · label index refreshed Oct 3, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
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
LabelerCardinal Health
FDA applicationM018 (OTC MONOGRAPH DRUG)
Labeler code70000
First marketedFeb 2019
Product typeHuman Otc Drug
Portfolio84 products on file
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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 openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
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 ▾
Uses • for the temporary relief of burning and irritation due to dryness of the eye
⏱️ Dosage and Administration ▾
Directions • Instill 1 or 2 drops in the affected eye(s) as needed • Children under 6 years of age: ask a doctor
⚠️ Warnings ▾
Warnings For external use only Do not use • if this product changes color or becomes cloudy • if you are sensitive to any ingredient in this product When using this product • do not touch the 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(s) gets worse or lasts more than 72 hours
🧪 Active Ingredient ▾
Active ingredients Polyethylene glycol 400 0.4% Propylene glycol 0.3%
🧪 Inactive Ingredients ▾
Inactive ingredients Aminomethylpropanol, benzalkonium chloride as preservative, boric acid, hypromellose, potassium chloride, purified water, sodium chloride, sorbitol
🎯 Purpose ▾
Purpose Polyethylene glycol 400............. Lubricant Propylene glycol............ Lubricant
📄 Do Not Use ▾
Do not use • if this product changes color or becomes cloudy • if you are sensitive to any ingredient in this product
📄 When Using This Product ▾
When using this product • do not touch the tip of container to any surface to avoid contamination • replace cap after each use
📄 Stop Use and Ask a Doctor If ▾
Stop use and ask a doctor if • you feel eye pain • changes in vision occur • redness or irritation of the eye(s) gets worse or lasts more than 72 hours
📄 Keep Out of Reach of Children ▾
Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
📄 Other Information ▾
Other information RETAIN THIS CARTON FOR FUTURE REFERENCE Store at room temperature
📄 Package Label / Principal Display Panel ▾
Single15 ml size
twin size
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 ↗
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
8K
Units reimbursed last 4 qtrs
125.6K
Gross reimbursed last 4 qtrs
$119.3K
Avg / prescription
$14.97
Avg / unit
$0.9504
Latest quarter Q1 2026
736Rx
Medicaid pays / mL
$0.9504
gross reimbursed
vs
NADAC / mL
$0.3625
acquisition cost
=
Spread
+$0.5879
+162% 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 ⓘ
Fee-for-service · 7,558 Rx Managed care · 412 Rx
State Medicaid map
Units reimbursed · per 100k residents
1.6606
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
Prescriptions—
Units—
Reimbursed—
🏆 Top states by units · per 100k residents
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.
Medicaid utilization by pack size
Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
Drug total (last 4 qtrs): 7,970 Rx · 125,562 units · $119,335 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.
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 Leader Ultra Lubricating Eye Drops (this brand).
Top reported reactions
Reporter sex
Male · 100%
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.
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.