Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
Leader Restorative Formula Lubricant Eye Drops propylene glycol .6 g/100mL Solution/ Drops — NDC 70000-0013-1 (Billing 70000-0013-01)
by Cardinal Health · 1 BOTTLE, DROPPER in 1 BOX / 15 mL in 1 BOTTLE, DROPPER
This is a package of Leader Restorative Formula Lubricant Eye Drops propylene glycol .6 g/100mL Solution/ Drops from Cardinal Health, marketed since Apr 2019 and currently FDA-listed; retail pharmacies pay about $0.2141 per mL (NADAC). It is the main listing for this product, which comes in 2 package sizes.
NDC 70000-0013-01
🏷️ FDA NDC (as labeled)
70000-0013-1
billing pads the package segment with a zero
This package
Contains15 mL in 1 bottle, dropper
Cost per mL$0.2141 NADAC
Per package$3.21 / 15 ml
Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.8168/unit — full pricing hub ↓
Main listing for product 70000-0013 · Also comes in:
2 bottles 70000-0013-2
🗂️ 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 →
⚠️
Other active recalls for Propylene Glycol (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Dec 31, 2025 — Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. (Wizcure Pharmaa Private Limited) · FDA recall D-0348-2026
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)
70000-0013-1
Product NDC
70000-0013
11-digit billing NDC
70000001301
NCPDP billing unit
ML — per mL (volume)
RxCUI
1041798
UNII
6DC9Q167V3
Application #
M018
SPL Set ID
87fef7e4-e5a8-4aad-94d2-f80f34826d97
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2019-04-30
Marketing end
2027-09-30
Route
OPHTHALMIC
Dosage form
SOLUTION/ DROPS
Substance
PROPYLENE GLYCOL
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
GPI-14
86200060002015
GPI class
Lubricant Eye Drops
GCN Seq No
066795
GCN
29189
HICL code
003808
Ingredient (HICL)
Propylene Glycol
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
LUBRICANT 0.6% EYE DROP
FDB brand name
Lubricant Eye Drop
Legend status
O — Over-the-counter (OTC) drug or device
Quick answers
- GSN (GCN sequence number): 066795
- GCN: 29189
- GPI-14 (Medi-Span): 86200060002015
- HICL (First Databank): 003808
- AHFS class code: 52:92.00.00
- RxCUI (RxNorm): 1041798
Why two NDCs?
The FDA registers this code as 70000-0013-1 — 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 → 70000-0013-01. 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 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
Clinical
Label name LUBRICANT 0.6% EYE DROP Ingredient Propylene Glycol
🧪 What is this product?
Leader Restorative Formula Lubricant Eye Drops is an over-the-counter eye drop solution containing propylene glycol. Propylene glycol is a humectant commonly used in lubricating eye drops to help retain moisture and reduce dryness on the eye surface. This product is marketed as an OTC monograph drug, meaning it follows FDA's established rules for over-the-counter eye lubricants rather than undergoing individual product review.
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 1, 2026
💬 Questions about 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 | $0.214 | $3.21 / 15 ml |
| Medicaid paysCMS SDUD · 12 mo | $0.8168 | $12.25 / 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 54% over the last 5 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 May 20, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q4 2025
- 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 |
|---|---|---|---|---|---|---|
| 70000-0013-01 You're viewing this Main listing | 1 BOTTLE, DROPPER in 1 BOX / 15 mL in 1 BOTTLE, DROPPER | $0.2141 / mL | $3.21 | 2019-04-30 | — | Active |
| 70000-0013-02 70000-0013-2 | 2 BOTTLE, DROPPER in 1 BOX / 15 mL in 1 BOTTLE, DROPPER | $0.1561 / mL | $4.68 | 2019-04-30 | — | Discontinued by firm |
Per mL, this pack runs about 37% above the cheapest pack (NDC 70000-0013-02, $0.1561 vs $0.2141 NADAC).
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 Restorative Formula Lubricant Eye Drops propylene glycol .6 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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Leader Restorative Formula Lubricant Eye Drops .6 g/100mLthis 70000-0013-01 | Cardinal | 1 bottle | $0.214 | — | Availability likely | — |
| Systane Balance .06 mg/mL 00065-1433-02 | Alcon | 1 bottle | $1.168 | — | Availability likely | +445% |
| Systane COMPLETE PF .06 mg/mL 00065-1509-28 | Alcon | 1 bottle | $1.347 | — | Availability likely | +529% |
| Systane COMPLETE .06 mg/mL 00065-0481-01 | Alcon | 1 bottle | — | — | FDA listed | — |
| Systane COMPLETE PF .06 mg/mL 00065-1530-01 | Alcon | 5 vials | — | — | FDA listed | — |
| OneDrop .6 g/100mL 57619-0306-01 | LABORATORIOS | 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file · file of May 20, 2026
Availability & generic status
🏛️
2019
On the market since
Apr 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 Sep 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.
Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 1, 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 marketedApr 2019
Product typeHuman Otc Drug
Portfolio84 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.
- 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
🎯 Indications and Usage ▾
Uses • for the temporary relief of burning and irritation due to dryness of the eye
⏱️ Dosage and Administration ▾
Directions Shake well before using. Instill 1 or 2 drops in the affected eye(s) as needed
⚠️ Warnings ▾
Warnings For external use only Do not use • if this product changes color • if you are sensitive to any ingredient in this product When using this product • do not touch tip of container to any surface to avoid contamination • replace cap after each use Stop use and ask a doctor if • you experience eye pain • changes in vision occur • redness or irritation of the eye(s) gets worse, persists or lasts more than 72 hours
🧪 Active Ingredient ▾
Active ingredients Propylene glycol....0.6%
🧪 Inactive Ingredients ▾
Inactive ingredients Benzalkonium chloride, boric acid, castor oil, disodium edetate hydrate, polyoxyethylene sorbitan monooleate, potassium chloride, purified water, sodium borate, sodium chloride. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.
🎯 Purpose ▾
Purpose Propylene glycol............ Lubricant
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 – Q4 2025 · 4 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
17.1K
Units reimbursed last 4 qtrs
265.6K
Gross reimbursed last 4 qtrs
$216.9K
Avg / prescription
$12.69
Avg / unit
$0.8168
Latest quarter Q4 2025
1.3KRx
Medicaid pays / mL
$0.8168
gross reimbursed
vs
NADAC / mL
$0.2141
acquisition cost
=
Spread
+$0.6027
+282% 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 · 16,622 Rx Managed care · 473 Rx
State Medicaid map
Units reimbursed · per 100k residents
3.11,024
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): 17,095 Rx · 265,581 units · $216,924 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 Restorative Formula Lubricant Eye Drops (this brand).
Top reported reactions
Reporter sex
Male · 45%
Female · 55%
Serious outcomes
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.