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Eye Allergy Itch and Redness Relief Olopatadine Hydrochloride 1 mg/mL Solution/ Drops — NDC 70000-0054-01 package photo

Eye Allergy Itch and Redness Relief Olopatadine Hydrochloride 1 mg/mL Solution/ Drops

by CARDINAL HEALTH 110, LLC. DBA LEADER · 1 BOTTLE, PLASTIC in 1 CARTON (70000-0054-1) / 5 mL in 1 BOTTLE, PLASTIC
NDC 70000-0054-01
🏷️ FDA NDC (as labeled) 70000-0054-1 billing pads the package segment with a zero
OTC Generic On market Non-controlled
🗂️ Data synced 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

🆔 Identity & classification

FDA NDC (as labeled) 70000-0054-1
Product NDC 70000-0054
11-digit billing NDC 70000005401
NCPDP billing unit ML — per mL (volume)
RxCUI 1111339
UNII 2XG66W44KF
Application # ANDA209619
SPL Set ID 5255d142-7d04-ab80-fa97-b11c4486e42c
Established class (EPC) Histamine-1 Receptor Antagonist; Histamine-1 Receptor Inhibitor; Mast Cell Stabilizer
Mechanism of action Histamine H1 Receptor Antagonists
Physiologic effect Decreased Histamine Release
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-01-15
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance OLOPATADINE HYDROCHLORIDE
GPI-14 86802065102020
GPI class Eye Allergy Itch/Redness Rel
GCN Seq No 030796
GCN 68321
HICL code 012815
Ingredient (HICL) Olopatadine Hcl
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 Q6R
Therapeutic class — specific (HIC3) Eye Antihistamines
AHFS code 52:02.00.00
AHFS class Antiallergic Agents
FDB label name EYE ALLERGY ITCH-RED 0.1% DROP
FDB brand name Eye Allergy Itch-Redness Rlf
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 70000-0054-1 — 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 → 70000-0054-01. 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 Histamine-1 Receptor Inhibitor class.

Pharmacologic class Histamine-1 Receptor Inhibitor, Histamine-1 Receptor Antagonist, Mast Cell Stabilizer
Drug family (ATC) Antiallergic agents, excl. corticosteroids, Other antiallergics
How it works Histamine H1 Receptor Antagonists
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
Application holderGLAND PHARMA LTD
FDA applicationANDA209619 (ANDA)
Labeler code70000
First marketedJan 2021
Product typeHuman Otc Drug
Portfolio162 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 EYE ALLERGY ITCH-RED 0.1% DROP Ingredient Olopatadine Hcl
📗 Our plain-language guide HelloPharmacist
  • It does both, but with different products. The eye drops are for allergy-related itchy and red eyes. The nasal spray — brands like Patanase — is for seasonal allergic rhinitis, mea...
  • What exactly does olopatadine treat — is it just for eyes, or can it help my runny nose too?
  • You need to take your contacts out before you put the drops in. Wait at least 10 minutes after using the drops before you put them back in. Also, don't wear contacts at all if your...
  • Can I wear my contact lenses while using olopatadine eye drops?
📖 Read our full Olopatadine guide →

Supplement & herbal interactions

Some supplements/herbs that may interact with Olopatadine Hydrochloride — tap one for details:

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Olopatadine Hydrochloride (3 interactions) — ranked by severity →
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 QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • 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 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • 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 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.

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

The official label also statesBenzalkonium chloride 0.01%, Dibasic sodium phosphate, Hydrochloric acid and /or Sodium hydroxide (to adjust pH), Sodium chloride and Water for Injection.

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 $1.221 $6.10 / 5 ml
Medicaid paysCMS SDUD · 12 mo $3.24 $16.22 / 5 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 Jul 2022 Jan 2024 May 2026 $1.704 $1.165
▼ Down 18% 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Eye Allergy Itch and Redness Relief 1 mg/mLthis 70000-0054-01 CARDINAL 1 bottle $1.221 — Availability likely —
Olopatadine Hydrochloride Ophthalmic Solution 1 mg/mL 00536-1308-40 Rugby 1 bottle $1.223 — Discontinued +0%
Olopatadine Hydrochloride 1 mg/mL 00536-1445-40 RUGBY 1 bottle $1.268 — Availability likely +4%
olopatadine hydrochloride 1 mg/mL 16571-0882-05 Rising 5 ml $1.268 — Availability likely +4%
Olopatadine Hydrochloride Ophthalmic 1 mg/mL 43598-0765-07 Dr. 1 bottle $1.268 — Availability likely +4%
Olopatadine Hydrochloride 1 mg/mL 46122-0672-64 Amerisource 1 bottle $1.268 — Availability likely +4%
Leader Olopatadine Hydrochloride Ophthalmic Solution 1 mg/mL 70000-0717-01 CARDINAL 1 bottle $1.268 — Availability likely +4%
Olopatadine 1 mg/mL 70069-0017-01 Somerset 1 bottle $1.268 — Availability likely +4%
Olopatadine Hcl 1 mg/mL 70512-0520-05 Sola 1 bottle $1.268 — Availability likely +4%
Eye Allergy Itch and Redness Relief 1 mg/mL 70677-1156-01 Strategic 1 bottle $1.268 — Availability likely +4%
Olopatadine Hydrochloride 1 mg/mL 70677-1280-01 Strategic 1 bottle $1.268 — Availability likely +4%
Pataday Twice A Day Relief 1 mg/mL 00065-4274-01 Alcon 1 bottle $2.482 — Availability likely +103%
Olopatadine Hydrochloride 1 mg/mL 62332-0501-05 Alembic 1 bottle $3.065 — FDA listed +151%
Olopatadine Hydrochloride 1 mg/mL 00363-0200-40 WALGREEN 1 bottle — — FDA listed —
Olopatadine Hydrochloride Ophthalmic Solution 1 mg/mL 00363-0867-01 WALGREEN 1 bottle — — FDA listed —
Olopatadine Hydrochloride Ophthalmic Solution 1 mg/mL 00363-7130-05 Walgreens 1 bottle — — FDA listed —
Olopatadine Hydrochloride Ophthalmic Solution 1 mg/mL 11673-0689-05 Target 1 bottle — — FDA listed —
Olopatadine Hydrochloride 1 mg/mL 11822-0064-01 RITE 1 bottle — — FDA listed —
Olopatadine Hydrochloride Ophthalmic Solution 1 mg/mL 11822-9976-05 Rite 1 bottle — — FDA listed —
Olopatadine Hydrochloride Ophthalmic Solution 1 mg/mL 24208-0966-01 Bausch 1 bottle — — FDA listed —
Olopatadine Hydrochloride 1 mg/mL 30142-0064-64 Kroger 1 bottle — — FDA listed —
Eye Allergy Itch and Redness Relief Twice Daily Relief 1 mg/mL 43598-0826-07 Dr. 1 bottle — — FDA listed —
Olopatadine Hydrochloride 1 mg/mL 46122-0823-29 AmerisourceBergen 1 bottle — — FDA listed —
Olopatadine Hydrochloride 1 mg/mL 46708-0709-05 Alembic 1 bottle — — FDA listed —
Olopatadine Hydrochloride 1 mg/mL 50090-6341-00 A-S 1 bottle — — FDA listed —
Olopatadine 1 mg/mL 50090-7959-00 A-S 1 bottle — — FDA listed —
Olopatadine hydrochloride 1 mg/mL 51407-0663-05 Golden 1 bottle — — FDA listed —
Olopatadine Hydrochloride 1 mg/mL 51407-0938-05 Golden 1 bottle — — FDA listed —
Olopatadine Hydrochloride Ophthalmic Solution Twice Daily 1 mg/mL 55910-0109-05 DOLGENCORP, 1 bottle — — FDA listed —
Olopatadine Hydrochloride 1 mg/mL 58602-0006-40 Aurohealth 1 bottle — — FDA listed —
Olopatadine Hydrochloride 1 mg/mL 58602-0009-40 Aurohealth 1 bottle — — FDA listed —
Olopatadine Hydrochloride 1 mg/mL 58602-0012-40 Aurohealth 1 bottle — — FDA listed —
Olopatadine hydrochloride 1 mg/mL 60505-6221-00 Apotex 1 bottle — — FDA listed —
Olopatadine Hydrochloride 1 mg/mL 62332-0709-05 Alembic 1 bottle — — FDA listed —
Olopatadine Hydrochloride Ophthalmic Solution 1 mg/mL 63868-0822-05 Chain 1 bottle — — FDA listed —
olopatadine hydrochloride ophthalmic 1 mg/mL 68083-0477-01 Gland 1 bottle — — FDA listed —
Olopatadine Hydrochloride 1 mg/mL 69168-0480-02 Allegiant 2 bottles — — FDA listed —
CVS Eye Allergy Itch Relief Twice Daily 1 mg/mL 69842-0268-05 CVS 1 bottle — — FDA listed —
Olopatadine Hydrochloride 1 mg/mL 72036-0008-40 Harris 1 bottle — — FDA listed —
Olopatadine Hydrochloride 1 mg/mL 72476-0852-64 Retail 1 bottle — — FDA listed —
Olopatadine Hydrochloride 1 mg/mL 72657-0168-50 GLENMARK 1 bottle — — FDA listed —
Olopatadine Hydrochloride 1 mg/mL 76162-0020-40 TOPCO 1 bottle — — FDA listed —
Olopatadine Hydrochloride 1 mg/mL 79481-1000-01 Meijer 1 bottle — — FDA listed —
Olopatadine Hydrochloride 1 mg/mL 79903-0000-40 Wal-Mart 1 bottle — — FDA listed —
Equate Olopatadine Hydrochloride Ophthalmic Solution 1 mg/mL 79903-0319-01 WAL-MART 1 bottle — — FDA listed —
Olopatadine Hydrochloride 1 mg/mL 82442-0966-01 TARGET 1 bottle — — FDA listed —
Olopatadine Hydrochloride 1 mg/mL 85766-0111-05 Sportpharm 1 bottle — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2021
On the market since
Jan 2021
📍
2026
Currently FDA-listed
5 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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 70000-0054-01, 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
26.2K
Units reimbursed last 4 qtrs
135.3K
Gross reimbursed last 4 qtrs
$438.9K
Avg / prescription
$16.74
Avg / unit
$3.2441
Latest quarter Q4 2025
2.2KRx
Medicaid pays / mL
$3.2441
gross reimbursed
vs
NADAC / mL
$1.2205
acquisition cost
=
Spread
+$2.0236
+166% 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 ⓘ
90% FFS
Fee-for-service · 23,581 Rx Managed care · 2,636 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 1,260 units · 22.0 per 100k residents MN Wisconsin: 380 units · 6.4 per 100k residents WI Michigan: 1,668 units · 16.6 per 100k residents MI New York: 86,557 units · 442 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 60 units · 1.4 per 100k residents OR Nevada: 65 units · 2.0 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: 130 units · 1.9 per 100k residents IN Ohio: 705 units · 6.0 per 100k residents OH Pennsylvania: 3,960 units · 30.6 per 100k residents PA New Jersey: 1,688 units · 18.2 per 100k residents NJ Massachusetts: no data reported MA California: 33,054 units · 84.8 per 100k residents CA Utah: no data reported UT Colorado: 170 units · 2.9 per 100k residents CO Nebraska: 215 units · 10.9 per 100k residents NE Missouri: 1,170 units · 18.9 per 100k residents MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: 795 units · 9.1 per 100k residents VA Maryland: 425 units · 6.9 per 100k residents MD Connecticut: 285 units · 7.9 per 100k residents CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: 325 units · 11.1 per 100k residents KS Arkansas: no data reported AR Tennessee: 520 units · 7.3 per 100k residents TN North Carolina: 135 units · 1.2 per 100k residents NC South Carolina: no data reported SC Delaware: 60 units · 5.8 per 100k residents 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.: 105 units · 15.5 per 100k residents DC Hawaii: no data reported HI Texas: 1,568 units · 5.1 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
1.2442
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 442 /100k
2 California 84.8 /100k
3 Pennsylvania 30.6 /100k
4 Minnesota 22.0 /100k
5 Missouri 18.9 /100k
6 New Jersey 18.2 /100k
7 Michigan 16.6 /100k
8 D.C. 15.5 /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.

🔬 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 Olopatadine Hydrochloride Ophthalmic — the ingredient across all brands.

Top reported reactions

Treatment Failure1,933
Headache117
Nausea117
Diarrhoea114
Fatigue103
Pneumonia103
Pyrexia102

Age at onset

Child15
Adolescent18
Adult282
Elderly194

Reporter sex

4,005 reports
Male · 32%
Female · 68%
Unknown · 0%

Serious outcomes

Hospitalization774
Life-threatening131
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,938 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
70000-0054-01 You're viewing this 1 BOTTLE, PLASTIC in 1 CARTON (70000-0054-1) / 5 mL in 1 BOTTLE, PLASTIC 2021-01-15 Active

📄 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 16 words ▾

USES temporarily relieves itchy and red eyes due to pollen, ragweed, grass, animal hair and dander

⏱️ Dosage and Administration 66 words ▾

DIRECTIONS • adults and children 2 years of age and older: • put 1 drop in the affected eye(s) twice daily, every 6 to 8 hours, no more than twice per day • if using other ophthalmic products while using this product, wait at least 5 minutes between each product • replace cap after each use • children under 2 years of age: consult a doctor

⚠️ Warnings 5 words ▾

WARNINGS For external use only

🧪 Active Ingredient 9 words ▾

ACTIVE INGREDIENT Olopatadine (0.1%) (equivalent to olopatadine hydrochloride 0.111%)

🧪 Inactive Ingredients 23 words ▾

INACTIVE INGREDIENTS Benzalkonium chloride 0.01%, Dibasic sodium phosphate, Hydrochloric acid and /or Sodium hydroxide (to adjust pH), Sodium chloride and Water for Injection.

🎯 Purpose 5 words ▾

PURPOSE Antihistamine and redness reliever

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 70000-0053-01 · CARDINAL 70000-0055-01 · 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.