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Leader Restorative Formula Lubricant Eye Drops propylene glycol .6 g/100mL Solution/ Drops — NDC 70000-0013-02 package photo
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 70000-0013-2 (Billing 70000-0013-02)

by Cardinal Health · 2 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, no longer marketed (first marketed Apr 2019), no longer in the FDA NDC Directory; retail pharmacies pay about $0.1561 per mL (NADAC).

NDC 70000-0013-02
🏷️ FDA NDC (as labeled) 70000-0013-2 billing pads the package segment with a zero
This package
Contains15 mL in 1 bottle, dropper Cost per mL$0.1561 NADAC Per package$4.68 / 30 ml Pack sizes2 compare ↓
Product page 70000-0013-01 Also comes in: 15 mL 70000-0013-1
OTC Discontinued Non-controlled ⚠ Discontinued by firm ⇄ 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 70000-0013-2 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
70000 labeler · 0013 product · 2 package
Barcode (UPC-A, from the NDC)
3 7000000132 2
FDA record last changed
Jul 24, 2026
⚠️
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 ↗
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70000-0013-2
Product NDC 70000-0013
11-digit billing NDC 70000001302
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 Discontinued
FDA listing status Discontinued by firm
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 70000-0013-2 — 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 → 70000-0013-02. 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 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.

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 $0.156 $4.68 / 30 ml
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.
NADAC price history (per mL) — tap or hover for the price & month
Jan 2022 May 2023 $0.156 $0.139
▲ Up 12% over the last 2 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 Per unit Per pack Marketing startMarketing endStatus
70000-0013-01 70000-0013-1 Main listing 1 BOTTLE, DROPPER in 1 BOX / 15 mL in 1 BOTTLE, DROPPER $0.2141 / mL $3.21 2019-04-30 Sep 30, 2027 Active
70000-0013-02 You're viewing this 2 BOTTLE, DROPPER in 1 BOX / 15 mL in 1 BOTTLE, DROPPER $0.1561 / mL $4.68 2019-04-30 — Discontinued by firm

This pack has the lowest per-mL cost of the 2 priced pack sizes ($0.1561 NADAC).

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 2 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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Leader Restorative Formula Lubricant Eye Drops .6 g/100mLthis 70000-0013-02 Cardinal 2 bottles $0.156 — Discontinued —
Systane Balance .06 mg/mL 00065-1433-02 Alcon 1 bottle $1.168 — Availability likely +648%
Systane COMPLETE PF .06 mg/mL 00065-1509-28 Alcon 1 bottle $1.347 — Availability likely +763%
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.

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.

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 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 D5340Y2I9G
    Castor oil is a natural plant-based oil used in medicines as a lubricant, laxative agent, and solvent. It helps medicine ingredients dissolve or flow smoothly and can aid bowel movement in formulations designed for that purpose.
  • 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 58O7V09UCI
    A surfactant derived from sorbitol and oleic acid, used to help dissolve, mix, and stabilize oils and other hard-to-blend ingredients in liquid medicines and creams.
  • 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 91MBZ8H3QO
    Sodium borate is an inorganic salt compound used in medicines as a buffer to help maintain a stable pH level, and sometimes as a mild preservative or cleansing agent in topical formulations.
  • 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 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.

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

The official label also statesInactive 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.

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

LabelerCardinal Health
FDA applicationM018 (OTC MONOGRAPH DRUG)
Labeler code70000
First marketedApr 2019
Product typeHuman Otc Drug
Portfolio84 products on file

More NDCs from Cardinal Health labeler code 70000

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 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 16 words ▾

Uses • for the temporary relief of burning and irritation due to dryness of the eye

⏱️ Dosage and Administration 16 words ▾

Directions Shake well before using. Instill 1 or 2 drops in the affected eye(s) as needed

⚠️ Warnings 81 words ▾

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 4 words ▾

Active ingredients Propylene glycol....0.6%

🧪 Inactive Ingredients 32 words ▾

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 4 words ▾

Purpose Propylene glycol............ Lubricant

📄 Do Not Use 20 words ▾

Do not use • if this product changes color • if you are sensitive to any ingredient in this product

📄 When Using This Product 23 words ▾

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 33 words ▾

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

📄 Keep Out of Reach of Children 20 words ▾

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 6 words ▾

Other information Store at room temperature.

📄 Questions or Comments 4 words ▾

Questions & comments? 1-888-527-4276

📄 Package Label / Principal Display Panel 4 words ▾

carton-single pack

carton-twin pack

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

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.
1 bottle70000-0013-01 17,095 Rx · $216,924
2 bottles this page70000-0013-02 No Medicaid data
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

Nausea146
Vomiting132
Dyspnoea116
Pulmonary Embolism107
Chronic Obstructive Pulmonary Disease104
Sepsis98
Abdominal Pain92

Reporter sex

0 reports
Male · 45%
Female · 55%

Serious outcomes

Hospitalization335
Death173
Disabling116
Life-threatening103
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 83 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 No longer marketed (per FDA listing data)
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) ✓ Available
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 bottle (70000-0013-01). 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?
Cardinal Health 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.
← 70000-0012-01 · Cardinal 70000-0014-01 · CARDINAL →
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.