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PATADAY ONCE DAILY RELIEF OLOPATADINE HYDROCHLORIDE 7 mg/mL Solution, 2 bottles — NDC 00065-0816-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

PATADAY ONCE DAILY RELIEF OLOPATADINE HYDROCHLORIDE 7 mg/mL Solution, 2 bottles — NDC 0065-0816-01 (Billing 00065-0816-01)

by Alcon Laboratories, Inc. · 2 BOTTLE, PLASTIC in 1 CARTON / 2.5 mL in 1 BOTTLE, PLASTIC

This is a package of 2 bottles of PATADAY ONCE DAILY RELIEF OLOPATADINE HYDROCHLORIDE 7 mg/mL Solution from Alcon Laboratories, Inc., marketed since Sep 2020 and currently FDA-listed.

NDC 00065-0816-01
🏷️ FDA NDC (as labeled) 0065-0816-01 billing pads the labeler segment with a zero
This package
Contains2 bottles Medicaid pays$6.09 / unit · 12 mo Per package$30.47 / 5 ml · Medicaid Pack sizes4 compare ↓
Product page 00065-0816-04 Also comes in: 1 bottle 0065-0816-02 2.5 mL 0065-0816-04 3 bottles 0065-0816-12
OTC Brand On market Non-controlled ⇄ 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 0065-0816-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0065 labeler · 0816 product · 01 package
Package marketed since
Jan 4, 2021
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 0065081601 4
Medicaid fills, this package
531 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0065-0816-01
Product NDC 0065-0816
11-digit billing NDC 00065081601
NCPDP billing unit ML — per mL (volume)
RxCUI 1601086, 2474007
UNII 2XG66W44KF
Application # NDA206276
SPL Set ID 6d07a5d6-265c-4735-97b3-8a2575b276cb
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 NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-09-01
Route OPHTHALMIC
Dosage form SOLUTION
Substance OLOPATADINE HYDROCHLORIDE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 86802065102040
GPI class Pataday
GCN Seq No 073483
GCN 37855
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 PATADAY ONCE DAILY 0.7% DROPS
FDB brand name Pataday Once Daily Relief
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 073483
  • GCN: 37855
  • GPI-14 (Medi-Span): 86802065102040
  • HICL (First Databank): 012815
  • AHFS class code: 52:02.00.00
  • RxCUI (RxNorm): 1601086
Why two NDCs? The FDA registers this code as 0065-0816-01 — a 4-4-2 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 labeler segment → 00065-0816-01. 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.

Clinical

Label name PATADAY ONCE DAILY 0.7% DROPS Ingredient Olopatadine Hcl
📖 What it is MedlinePlus · NLM

Olopatadine ophthalmic is used to relieve itchy eyes caused by allergic reactions. Olopatadine is in a class of medications called mast cell stabilizers. It works by preventing the release of substances that cause eye itching.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • The eye drops relieve itchy eyes from allergies, and some products relieve redness too. The nasal spray relieves seasonal allergic rhinitis symptoms in adults and children 6 and ol...
  • It depends on the product. Some eye drops are twice daily, 6 to 8 hours apart, and others once daily. The nasal spray is twice daily. Follow your label or prescriber.
  • Take your lenses out before using the drops and wait at least 10 minutes before putting them back. Don't wear lenses if your eyes are red. These drops aren't for contact lens irrit...
  • With the nasal spray, a bitter taste, headache, nosebleeds and sore throat are common. It can also make you drowsy, so be careful driving and skip alcohol.
📖 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.

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 Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $6.09 $30.47 / 5 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
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
00065-0816-01 You're viewing this 2 BOTTLE, PLASTIC in 1 CARTON / 2.5 mL in 1 BOTTLE, PLASTIC — — 2021-01-04 — Active
00065-0816-02 0065-0816-02 1 BOTTLE, PLASTIC in 1 CARTON / .5 mL in 1 BOTTLE, PLASTIC — — 2021-01-04 — Active
00065-0816-04 0065-0816-04 Main listing 1 BOTTLE, PLASTIC in 1 CARTON / 2.5 mL in 1 BOTTLE, PLASTIC $6.20 / mL $15.51 2020-09-01 — Active
00065-0816-12 0065-0816-12 3 BOTTLE, PLASTIC in 1 CARTON / 2.5 mL in 1 BOTTLE, PLASTIC — — 2022-01-24 — Active

This pack accounts for about 1.3% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package contains 2 bottles — 2 bottle, plastic in 1 carton / 2.5 ml in 1 bottle, plastic.
How does this package differ from NDC 00065-0816-02?
Both are PATADAY ONCE DAILY RELIEF OLOPATADINE HYDROCHLORIDE 7 mg/mL Solution — the drug itself is identical. This page's package is the 2 bottles one, while NDC 00065-0816-02 is the 1 bottle package.
What NDC number is used to bill for this package of PATADAY ONCE DAILY RELIEF OLOPATADINE HYDROCHLORIDE 7 mg/mL Solution?
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
Pataday Once Daily Relief 7 mg/mLthis 00065-0816-01 Alcon 2 bottles — — FDA listed —
Eye Allergy Itch Relief 7 mg/mL 00363-1325-01 Walgreen 1 bottle — — FDA listed —
Olopatadine HCl 7 mg/mL 00536-1478-23 Rugby 1 bottle — — FDA listed —
Olopatadine Hydrochloride Ophthalmic Solution 7 mg/mL 51316-0567-01 CVS 1 bottle — — FDA listed —
Allergy Relief Eye Drops 7 mg/mL 51316-0633-02 CVS 2 bottles — — FDA listed —
olopatadine hydrochloride ophthalmic 7 mg/mL 68083-0398-01 Gland 1 bottle — — FDA listed —
Eye Allergy Itch Relief 7 mg/mL 70000-0746-01 CARDINAL 1 bottle — — FDA listed —
Olopatadine Hydrochloride Ophthalmic Solution 7 mg/mL 75907-0285-10 Dr. 1000 bottles — — FDA listed —
Eye Allergy Itch Relief 7 mg/mL 75907-0343-25 Dr. 2 bottles — — FDA listed —
Eye Allergy Itch Relief 7 mg/mL 82442-0027-25 TARGET 1 bottle — — FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be 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

🏛️
2015
First FDA approval
Jan 2015
📍
2026
Currently FDA-listed
11 years listed
🛡️
2032
Latest patent/protection listed
not a guaranteed launch date
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through May 2032. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Jan 30, 2015 RLD RS ⏳ ~5.6 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 8791154 — method of use (U-1680)
US 9533053 — drug product
2015 2017 2019 2021 2023 2025 2027 2029 2031
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (2)
PatentTypeUse codeExpires
US 8791154 ↗ Method of use U-1680 May 19, 2032
US 9533053 ↗ Drug product — May 19, 2032
Common questions
Is there a generic version of PATADAY ONCE DAILY 0.7% DROPS?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for PATADAY ONCE DAILY 0.7% DROPS. See the alternatives section for substitutable, lower-cost products.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
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.

🧪 Avoiding an ingredient? See Olopatadine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 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 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 P6BYU725IU
    A modified carbohydrate that acts as a solubilizer and stabilizer in medicines. It helps dissolve poorly water-soluble drugs and protects active ingredients from degradation during storage.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • UNII B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • 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 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 statesbenzalkonium chloride 0.015%, boric acid, hydrochloric acid/sodium hydroxide (to adjust pH), hydroxypropylgamma- cyclodextrin, hypromellose, mannitol, polyethylene glycol 400, povidone, and purified water

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

LabelerAlcon Laboratories, Inc.
Application holderALCON LABORATORIES INC
FDA applicationNDA206276 (NDA)
Labeler code00065
First marketedSep 2020
Product typeHuman Otc Drug
Portfolio55 products on file

More NDCs from Alcon Laboratories, Inc. labeler code 00065

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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 14 words ▾

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

⏱️ Dosage and Administration 62 words ▾

Directions adults and children 2 years of age and older: put 1 drop in the affected eye(s) once daily do not use more than 1 drop in each eye 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

📦 Storage and Handling 12 words ▾

Other information only for use in the eye store between 2°-25°C (36°-77°F)

🧪 Active Ingredient 11 words ▾

Active Ingredients Purpose Olopatadine (0.7%) (equivalent to olopatadine hydrochloride 0.776%) Antihistamine

🧪 Inactive Ingredients 24 words ▾

Inactive ingredients benzalkonium chloride 0.015%, boric acid, hydrochloric acid/sodium hydroxide (to adjust pH), hydroxypropylgamma- cyclodextrin, hypromellose, mannitol, polyethylene glycol 400, povidone, and purified water

🎯 Purpose 11 words ▾

Active Ingredients Purpose Olopatadine (0.7%) (equivalent to olopatadine hydrochloride 0.776%) Antihistamine

📄 Do Not Use 69 words ▾

Do not use if solution changes color or becomes cloudy if you are sensitive to any ingredient in this product to treat contact lens related irritation

When using this product do not touch tip of container to any surface to avoid contamination remove contact lenses before use wait at least 10 minutes before reinserting contact lenses after use do not wear a contact lens if your eye is red

📄 Stop Use and Ask a Doctor If 28 words ▾

Stop use and ask a doctor if you experience: eye pain changes in vision increased redness of the eye itching worsens or lasts for more than 72 hours

📄 Keep Out of Reach of Children 19 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📄 Questions or Comments 9 words ▾

Questions? In the U.S., call 1-800-757-9195 or email [email protected]

📄 Package Label / Principal Display Panel ~2 min read ▾

PRINCIPAL DISPLAY PANEL EXTRA STRENGTH Pataday ® ONCE DAILY RELIEF Olopatadine hydrochloride ophthalmic solution 0.7% Antihistamine Eye Allergy Itch Relief FULL 24 HOUR Works in Minutes Relief from Allergens: • Pet Dander • Pollen • Grass • Ragweed Alcon STERILE 2.5 mL (0.085 FL OZ) EXTRA STRENGTH Pataday ® ONCE DAILY RELIEF TAMPER EVIDENT: For your protection, this bottle has a seal imprinted with Alcon around the neck. Do not use if seal is damaged or missing at time of purchase. 30 DAY SUPPLY Eye Allergy Itch Relief Works in Minutes For Ages 2 and Older ________Fill Line________ Alcon Laboratories, Inc.

6201 South Freeway Fort Worth, Texas 76134 Country of Origin: Japan ACTUAL SIZE NDC: 0065-0816-04 300038456-0620 LOT: EXP.: 3187 EXTRA STRENGTH Pataday ® ONCE DAILY RELIEF Olopatadine hydrochloride ophthalmic solution 0.7% Antihistamine 2.5 mL (0.085 FL OZ) STERILE Only for use in the eye. Store between 2°– 25° C (36°– 77° F) TAMPER EVIDENT: For your protection, this bottle has a seal imprinted with Alcon around the neck. Do not use if seal is damaged or missing at time of purchase.

Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76134 LOT: EXP.: 300038442-0620 EXTRA STRENGTH Pataday ® ONCE DAILY RELIEF Olopatadine hydrochloride ophthalmic solution 0.7% Antihistamine Eye Allergy Itch Relief FULL 24 HOUR #1 DOCTOR RECOMMENDED OTC EYE ALLERGY BRAND* Works in Minutes Alcon STERILE 2.5 mL (0.085 fl oz) LOT: EXP: EXTRA STRENGTH Pataday ® ONCE DAILY RELIEF Olopatadine hydrochloride ophthalmic solution 0.7% Antihistamine Eye Allergy Itch Relief EXTRA STRENGTH Pataday ® ONCE DAILY RELIEF TAMPER EVIDENT: For your protection, this bottle has a seal imprinted around the neck.

Do not use if seal is damaged or missing at time of purchase. 30 DAY SUPPLY Eye Allergy Itch Relief Works in Minutes For Ages 2 and Older ________Fill Line________ Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134 Country of Origin: Japan ACTUAL SIZE NDC: 0065-0816-04 300071514-0325 *Based on a survey of eye care professionals, allergist, and primary care doctors.

December 2024. EXTRA STRENGTH Pataday ® ONCE DAILY RELIEF Olopatadine hydrochloride ophthalmic solution 0.7% Antihistamine EYE ALLERGY ITCH RELIEF 2.5 mL (0.085 fl oz) STERILE Only for use in the eye. Store between 2°– 25° C (36°– 77° F) TAMPER EVIDENT: For your protection, this bottle has a seal imprinted around the neck.

Do not use if seal is damaged or missing at time of purchase. Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76134 LOT: EXP.: 300071826 -0425

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 – Q1 2026 · 5 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
531
Units reimbursed last 4 qtrs
2.3K
Gross reimbursed last 4 qtrs
$14.1K
Avg / prescription
$26.49
Avg / unit
$6.0949
Latest quarter Q1 2026
74Rx
Fee-for-service vs managed care ⓘ
75% FFS 25% MCO
Fee-for-service · 400 Rx Managed care · 131 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: 305 units · 5.3 per 100k residents MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 908 units · 4.6 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: 110 units · 0.9 per 100k residents OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported 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: 985 units · 27.2 per 100k residents 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
0.927.2
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 Connecticut 27.2 /100k
2 Minnesota 5.3 /100k
3 New York 4.6 /100k
4 Ohio 0.9 /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 bottle00065-0816-04 41,179 Rx · $874,500
2 bottles this page00065-0816-01 531 Rx · $14,066
1 bottle00065-0816-02 No Medicaid data
3 bottles00065-0816-12 No Medicaid data
Drug total (last 4 qtrs): 41,710 Rx · 121,804 units · $888,566 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 PATADAY ONCE DAILY RELIEF (this brand).

Top reported reactions

Treatment Failure1,934
Eye Irritation274
Vision Blurred220
Eye Discharge171
Headache156
Eye Pain154
Eye Pruritus132

Age at onset

Child22
Adolescent22
Adult362
Elderly251

Reporter sex

5,207 reports
Male · 31%
Female · 69%
Unknown · 0%

Serious outcomes

Hospitalization791
Death193
Life-threatening131
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,941 191
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
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) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
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) ✓ Available
“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

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
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.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Alcon Laboratories, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 1 bottle (00065-0816-02), 1 bottle (00065-0816-04), 3 bottles (00065-0816-12). 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?
Alcon Laboratories, Inc. 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.
← 00065-0800-50 · Alcon 00065-0817-01 · Alcon →
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.