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Leader Dry Eye Relief Eye Drops Glycerin, Hypromellose, Polyethylene glycol 400 .2 g/100mL; .2 g/100mL; 400 1 g/100mL Solution/ Drops — NDC 70000-0502-01 package photo

Leader Dry Eye Relief Eye Drops Glycerin, Hypromellose, Polyethylene glycol 400 .2 g/100mL; .2 g/100mL; 400 1 g/100mL Solution/ Drops

by CARDINAL HEALTH 110, LLC. DBA LEADER · 1 BOTTLE, PLASTIC in 1 CARTON (70000-0502-1) / 15 mL in 1 BOTTLE, PLASTIC
NDC 70000-0502-01
🏷️ FDA NDC (as labeled) 70000-0502-1 billing pads the package segment with a zero
This package
Contains15 mL in 1 bottle, plastic Cost per mL$0.1687 NADAC Per package$2.53 / 15 ml Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.7392/unit — full pricing hub ↓
Also comes in: 2 bottles 70000-0502-02
OTC On market Non-controlled
🗂️ Data synced Sep 3, 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

🚨
Active recall for this product.
Class II · Mar 3, 2026 — Lack of Assurance of Sterility (K.C. Pharmaceuticals, Inc) · FDA recall D-0411-2026
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗
⚠️
Other active recalls for Glycerin, Hypromellose, Polyethylene Glycol 400 (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 · Jun 13, 2023 — CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line. (K.C. Pharmaceuticals, Inc) · FDA recall D-0898-2023
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 70000-0502-1
Product NDC 70000-0502
11-digit billing NDC 70000050201
NCPDP billing unit ML — per mL (volume)
RxCUI 259581
UNII PDC6A3C0OX, 3NXW29V3WO, B697894SGQ
UPC 0096295137064, 0096295137071
Application # M018
SPL Set ID 2ded4bda-b3c3-4521-8701-5c8446fd148b
Established class (EPC) Non-Standardized Chemical Allergen
Physiologic effect Increased Histamine Release; Cell-mediated Immunity; Increased IgG Production
Chemical class Allergens; Glycerol
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 2027-02-28
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance GLYCERIN; HYPROMELLOSE, UNSPECIFIED; POLYETHYLENE GLYCOL 400
GCN Seq No 043044
GCN 92824
HICL code 020361
Ingredient (HICL) Peg 400/Hypromellose/Glycerin
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 DRY EYE RELIEF EYE DROPS
FDB brand name Dry Eye Relief
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 70000-0502-1 — 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 → 70000-0502-01. 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.

🏷️ RxNorm drug class

This medicine belongs to the Viscoelastic substances class.

Drug family (ATC) Viscoelastic substances
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerCARDINAL HEALTH 110, LLC. DBA LEADER
FDA applicationM018 (OTC MONOGRAPH DRUG)
Labeler code70000
First marketedApr 2019
Product typeHuman Otc Drug
Portfolio163 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.

🩺 Clinical

Label name DRY EYE RELIEF EYE DROPS Ingredient Peg 400/Hypromellose/Glycerin
🧪 What is this product?

Leader Dry Eye Relief is an over-the-counter eye drop solution marketed under FDA's OTC monograph rules for dry eye symptoms. It contains three lubricating ingredients: glycerin, hypromellose, and polyethylene glycol 400. These substances are commonly used together to coat and moisturize the eye surface, helping to relieve dryness and irritation. The drops are applied directly to the eye as needed.

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.

🧪 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 IY9XDZ35W2
    Dextrose is a simple sugar derived from corn or other sources. It serves as a filler and sweetener in medicines to add bulk, improve taste, and help stabilize the medication's form.
  • 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 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 8MDF5V39QO
    A white powder form of baking soda that acts as a buffer and pH regulator in medicines. It helps maintain the right acid-base balance and may aid tablet disintegration.
  • 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 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • 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 3980JIH2SW
    A salt form of phosphoric acid that acts as a buffer and pH adjuster in medicines. It helps keep the product at the correct acidity level for stability and effectiveness.
  • 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.

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

The official label also states​Inactive ingredients benzalkonium chloride, dextrose, edetate disodium, potassium chloride, purified water, sodium bicarbonate, sodium chloride, sodium citrate, 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.

💲 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 $0.169 $2.53 / 15 ml
Medicaid paysCMS SDUD · 12 mo $0.7392 $11.09 / 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 2021 May 2022 Oct 2022 Mar 2026 $0.169 $0.141
▲ Up 19% over the last 17 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sunmark Dry Eye Relief .2 g/100mL; .2 g/100mL; 400 1 g/100mL 49348-0095-29 Strategic 1 bottle $0.160 — FDA listed save 5%
GNP Eye Drops Dry Eye Relief .2 g/100mL; .2 g/100mL; 400 1 g/100mL 46122-0605-05 AmerisourceBergen 1 bottle $0.169 — Discontinued —
Leader Dry Eye Relief Eye Drops .2 g/100mL; .2 g/100mL; 400 1 g/100mLthis 70000-0502-01 CARDINAL 1 bottle $0.169 — Availability likely —
Rite Aid Eye Drops Dry Eye Relief .2 g/100mL; .2 g/100mL; 400 1 g/100mL 11822-1067-02 Rite 1 bottle — — FDA listed —
TopCare Health Dry Eye Relief Eye Drops 400 1 g/100mL; .2 g/100mL; .2 g/100mL 36800-0845-01 Topco 1 bottle — — FDA listed —
HEB Dry Eye Eye Drops .2 g/100mL; .2 g/100mL; 400 1 g/100mL 37808-0748-01 HEB 1 bottle — — FDA listed —
Meijer Dry Eye Relief .2 g/100mL; 400 1 g/100mL; .2 g/100mL 41250-0718-01 Meijer 1 bottle — — FDA listed —
Equate Eye Drops Dry Eye Relief .2 g/100mL; .2 g/100mL; 400 1 g/100mL 49035-0280-01 Wal-Mart 2 bottles — — FDA listed —
Discount Drug Mart Eye Drops Dry Eye Relief .2 g/100mL; .2 g/100mL; 400 1 g/100mL 53943-0032-01 Discount 1 bottle — — FDA listed —
Exchange Select Artificial Tears Lubricant Eye Drops 400 1 g/100mL; .2 g/100mL; .2 g/100mL 55301-0178-01 Army 1 bottle — — FDA listed —
Artificial Tears Lubricant Eye Drops .2 g/100mL; .2 g/100mL; 400 1 g/100mL 55651-0115-01 KC 1 bottle — — FDA listed —
DG Health Dry Eye Relief 400 1 g/100mL; .2 g/100mL; .2 g/100mL 55910-0362-01 Dolgencorp 1 bottle — — FDA listed —
Artificial Tears .002 mg/mg; .002 mg/mg; 400 .01 mg/mg 57896-0181-05 Geri-Care 1 bottle — — FDA listed —
Core Values Eye Drops Dry Eye Relief .2 g/100mL; .2 g/100mL; 400 1 g/100mL 63940-0035-01 Liberty 1 bottle — — FDA listed —
Artificial Tears .002 mg/mg; .002 mg/mg; 400 .01 mg/mg 68071-4555-05 NuCare 15 mg — — FDA listed —
Artificial Tears .002 mg/mg; .002 mg/mg; 400 .01 mg/mg 68788-7266-00 Preferred 1 bottle — — FDA listed —
Harris Teeter Eye Drops Artificial Tears .2 g/100mL; .2 g/100mL; 400 1 g/100mL 69256-0823-01 Harris 1 bottle — — FDA listed —
Crocodile Tears Lubricant Eye Drops .2 g/100mL; .2 g/100mL; 400 1 g/100mL 87522-0115-01 Crocodile 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.

🗺️ 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 70000-0502-01, 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
8.3K
Units reimbursed last 4 qtrs
129.1K
Gross reimbursed last 4 qtrs
$95.4K
Avg / prescription
$11.55
Avg / unit
$0.7392
Latest quarter Q4 2025
1.6KRx
Medicaid pays / mL
$0.7392
gross reimbursed
vs
NADAC / mL
$0.1687
acquisition cost
=
Spread
+$0.5705
+338% 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 ⓘ
98% FFS
Fee-for-service · 8,071 Rx Managed care · 189 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 1,140 units · 14.6 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 125,355 units · 641 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: 1,080 units · 11.6 per 100k residents NJ Massachusetts: 210 units · 3.0 per 100k residents MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: 1,290 units · 65.2 per 100k residents NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
3.0641
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 New York 641 /100k
2 Nebraska 65.2 /100k
3 Washington 14.6 /100k
4 New Jersey 11.6 /100k
5 Massachusetts 3.0 /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.

💊 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 bottle this page70000-0502-01 8,260 Rx · $95,410
2 bottles70000-0502-02 No Medicaid data
Drug total (last 4 qtrs): 8,260 Rx · 129,075 units · $95,410 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
70000-0502-01 You're viewing this 1 BOTTLE, PLASTIC in 1 CARTON (70000-0502-1) / 15 mL in 1 BOTTLE, PLASTIC $0.1687 / mL $2.53 2019-04-30 Active
70000-0502-02 2 BOTTLE, PLASTIC in 1 CARTON (70000-0502-2) / 15 mL in 1 BOTTLE, PLASTIC — — 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 NDC 70000-0502-01?
NDC 70000-0502-01 is listed by the FDA — 1 bottle, plastic in 1 carton / 15 ml in 1 bottle, plastic.
What NDC number is used to bill for this package of Leader Dry Eye Relief Eye Drops Glycerin, Hypromellose, Polyethylene glycol 400 .2 g/100mL; .2 g/100mL; 400 1 g/100mL Solution/ Drops?
Bill NDC 70000-0502-01 — the 11-digit billing format is 70000050201. 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.

📄 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 20 words ▾

​Uses for the temporary relief of burning and irritation due to dryness of the eye for protection against further irritation

⏱️ Dosage and Administration 12 words ▾

Directions Instill 1 or 2 drops in the affected eye(s) as needed

⚠️ Warnings 106 words ▾

​Warnings For external use only Do not use this product if solution changes color or becomes cloudy When using this product to avoid contamination, do not touch tip of container to any surface. Replace cap after using. remove contact lens before using 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 If pregnant or breast-feeding , ask a health professional before use. Keep out of reach of children If swallowed get medical help or contact a Poison Control Center (1-800-222-1222) right away.

🧪 Active Ingredient 9 words ▾

​Active ingredients Glycerin 0.2% Hypromellose 0.2% Polyethylene glycol 1%

🧪 Inactive Ingredients 23 words ▾

​Inactive ingredients benzalkonium chloride, dextrose, edetate disodium, potassium chloride, purified water, sodium bicarbonate, sodium chloride, sodium citrate, sodium phosphate dibasic, sodium phosphate monobasic

🎯 Purpose 6 words ▾

​Purpose Glycerin.....Lubricant Hypromellose.....Lubricant Polyethylene glycol 400.....Lubricant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 70000-0501-01 · Cardinal 70000-0504-01 · 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.