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Leader Eye Drops Redness Relief Glycerin, Naphazoline hydrochloride .25 g/100mL; .012 g/100mL Solution/ Drops — NDC 70000-0010-01 package photo

Leader Eye Drops Redness Relief Glycerin, Naphazoline hydrochloride .25 g/100mL; .012 g/100mL Solution/ Drops

by Cardinal Health · 1 BOTTLE, PLASTIC in 1 CARTON (70000-0010-1) / 15 mL in 1 BOTTLE, PLASTIC
NDC 70000-0010-01
🏷️ FDA NDC (as labeled) 70000-0010-1 billing pads the package segment with a zero
This package
Contains15 mL in 1 bottle, plastic Cost per mL$0.1036 NADAC Per package$1.55 / 15 ml Pack sizes2 compare ↓
Also comes in: 2 bottles 70000-0010-02
OTC On market Non-controlled
🗂️ Data synced Sep 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

🚨
Active recall for this product.
Class II · Mar 3, 2026 — Lack of Assurance of Sterility (K.C. Pharmaceuticals, Inc) · FDA recall D-0414-2026
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 70000-0010-1
Product NDC 70000-0010
11-digit billing NDC 70000001001
NCPDP billing unit ML — per mL (volume)
RxCUI 1046700
UNII PDC6A3C0OX, MZ1131787D
UPC 0096295137620, 0096295137637
Application # M018
SPL Set ID aee4bbe2-4f11-4c54-be8b-df48b3ba4f3a
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 2027-11-30
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance GLYCERIN; NAPHAZOLINE HYDROCHLORIDE
GCN Seq No 069113
GCN 32064
HICL code 037688
Ingredient (HICL) Naphazoline Hcl/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 Q6D
Therapeutic class — specific (HIC3) Eye Vasoconstrictors (Otc Only)
AHFS code 52:32.00.00
AHFS class Vasoconstrictors
FDB label name REDNESS RELIEF EYE DROPS
FDB brand name Redness Relief
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 70000-0010-1 — 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 → 70000-0010-01. 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 Non-Standardized Chemical Allergen class.

Pharmacologic class Non-Standardized Chemical Allergen
Drug family (ATC) Enemas, Other drugs for constipation
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
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.

🩺 Clinical

Label name REDNESS RELIEF EYE DROPS Ingredient Naphazoline Hcl/Glycerin
🧪 What is this product?

Leader Eye Drops Redness Relief is an over-the-counter eye drop solution marketed under FDA's monograph rules for ophthalmic decongestants. It contains naphazoline hydrochloride, a vasoconstrictor typically used to reduce redness in the eye, and glycerin, a lubricant commonly added to eye drops to help soothe and moisten the eye surface. This product is intended for instillation directly into the eye.

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 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 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 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 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.

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

The official label also statesbenzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate

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 $0.104 $1.55 / 15 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
Nov 2021 Oct 2022 Mar 2026 Sep 2026 $0.115 $0.095
▼ Down 1% 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
Foster and Thrive Redness Relief Eye Drops .012 g/100mL; .25 g/100mL 70677-1161-01 Strategic 1 bottle $0.101 — Availability likely save 2%
GNP Eye Drops Redness and Dry Eye Relief .25 g/100mL; .012 g/100mL 46122-0606-05 AmerisourceBergen 1 bottle $0.104 — Discontinued —
Leader Eye Drops Redness Relief .25 g/100mL; .012 g/100mLthis 70000-0010-01 Cardinal 1 bottle $0.104 — Availability likely —
Walgreens Redness Relief Eye Drops 15mL .25 g/100mL; .012 g/100mL 00363-4548-01 Walgreen 1 bottle — — FDA listed —
Pure Eyes Sterile Eyes .1 mg/mL; 2.5 mg/mL 20146-7000-01 SAMSON 1 bottle — — FDA listed —
Signature Care Eye Drops Redness and Dry Eye Relief .25 g/100mL; .012 g/100mL 21130-0703-01 Better 1 bottle — — FDA listed —
Kroger Eye Drops Redness Relief .25 g/100mL; .012 g/100mL 30142-0573-01 The 1 bottle — — FDA listed —
Meijer Redness Relief .012 g/100mL; .25 g/100mL 41250-0846-01 Meijer 1 bottle — — FDA listed —
Xpect Industrial Eye Relief .012 g/100mL; .25 g/100mL 42961-0255-01 Cintas 1 bottle — — FDA listed —
Colirio Ojo De Aguila Eye Drops .25 g/100mL; .012 g/100mL 48201-0106-01 Grandall 1 bottle — — FDA listed —
Colirio Oftal-Mycin .25 g/100mL; .012 g/100mL 48201-0107-01 Grandall 1 bottle — — FDA listed —
Discount Drug Mart Redness Relief Eye Drops .25 g/100mL; .012 g/100mL 53943-0074-01 Discount 1 bottle — — FDA listed —
Redness and Dry Eye Relief .25 g/100mL; .012 g/100mL 55651-0620-01 KC 1 bottle — — FDA listed —
Clear Eyes Redness Relief Handy Pocket Pal .00012 mg/mL; .0025 mg/mL 67172-0796-01 Prestige 1 bottle — — Discontinued —
Clear Eyes Redness Relief .12 mg/mL; 2.5 mg/mL 67172-0797-01 Prestige 1 bottle — — FDA listed —
Harris Teeter Redness Relief Eye Drops .25 g/100mL; .012 g/100mL 69256-0979-01 Harris 1 bottle — — FDA listed —
Equate Redness and Dry Eye Relief Eye Drops .25 g/100mL; .012 g/100mL 79903-0012-01 Wal-Mart 1 bottle — — FDA listed —
Equate Redness and Dry Eye Relief .25 g/100mL; .012 g/100mL 79903-0362-01 Walmart 1 bottle — — FDA listed —
Equaline Redness Relief Lubricant Eye Drops .25 g/100mL; .012 g/100mL 83455-0213-01 United 1 bottle — — FDA listed —
Code Red Eye Drops Micro 20 mg/8mL; .96 mg/8mL 83817-0102-01 4 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.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
70000-0010-01 You're viewing this 1 BOTTLE, PLASTIC in 1 CARTON (70000-0010-1) / 15 mL in 1 BOTTLE, PLASTIC $0.1036 / mL $1.55 2019-04-30 Active
70000-0010-02 2 BOTTLE, PLASTIC in 1 CARTON (70000-0010-2) / 15 mL in 1 BOTTLE, PLASTIC — — 2019-04-30 Active

Pack size FAQ

What quantity is in NDC 70000-0010-01?
NDC 70000-0010-01 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 Eye Drops Redness Relief Glycerin, Naphazoline hydrochloride .25 g/100mL; .012 g/100mL Solution/ Drops?
Bill NDC 70000-0010-01 — the 11-digit billing format is 70000001001. 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 41 words ▾

Uses for the relief of redness of the eye due to minor eye irritations for the temporary relief of burning and irritation due to dryness of the eye for use as a protectant against further irritation or dryness of the eye

⏱️ Dosage and Administration 23 words ▾

Directions Instill 1 or 2 drops in the affected eye(s) up to 4 times daily children under 6 years of age:ask a doctor

⚠️ Warnings 114 words ▾

Warnings For external use only Do not use if solution changes color or becomes cloudy Ask a doctor before use if you have narrow angle glaucoma When using this product to avoid contamination, do not touch tip of container to any surface replace cap after using overuse may produce increased redness of the eye pupils may become enlarged temporarily Stop use and ask a doctor if you experience eye pain you experience changes in vision you experience continued redness or irritation of the eye the condition worsens or persists for more than 72 hours 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 7 words ▾

Active ingredients Glycerin 0.25% Naphazoline hydrochloride 0.012%

🧪 Inactive Ingredients 12 words ▾

Inactive ingredients benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate

🎯 Purpose 5 words ▾

Purposes Glycerin...Lubricant Naphazoline hydrochloride...Redness reliever

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 70000-0009-01 · Cardinal 70000-0011-01 · 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.