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OLOPATADINE HYDROCHLORIDE 1 mg/mL Solution/ Drops — NDC 69168-480-02 (Billing 69168-0480-02)

by Allegiant Health · 2 BOTTLE in 1 CARTON / 5 mL in 1 BOTTLE

This is a package of OLOPATADINE HYDROCHLORIDE 1 mg/mL Solution/ Drops from Allegiant Health, marketed since May 2025 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 69168-0480-02
🏷️ FDA NDC (as labeled) 69168-480-02 billing pads the product segment with a zero
This package
Contains5 mL in 1 bottle Pack sizes2 compare ↓
Main listing for product 69168-480 · Also comes in: 5 mL 69168-480-65
OTC Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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 69168-480-02 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
69168 labeler · 480 product · 02 package
Package marketed since
Jul 31, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 6916848002 5
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 69168-480-02
Product NDC 69168-480
11-digit billing NDC 69168048002
RxCUI 1111339
UNII 2XG66W44KF
Application # ANDA078350
SPL Set ID fdb808ef-9d5f-4bc3-86e7-f519b5c75a46
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 2025-05-05
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance OLOPATADINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 1111339
Why two NDCs? The FDA registers this code as 69168-480-02 — a 5-3-2 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 product segment → 69168-0480-02. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

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

📗 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 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.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 5 mL
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 Marketing startMarketing endStatus
69168-0480-02 You're viewing this Main listing 2 BOTTLE in 1 CARTON / 5 mL in 1 BOTTLE 2025-07-31 — Active
69168-0480-65 69168-480-65 1 BOTTLE in 1 CARTON / 5 mL in 1 BOTTLE 2025-05-05 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 2 bottle in 1 carton / 5 ml in 1 bottle.
What NDC number is used to bill for this package of OLOPATADINE HYDROCHLORIDE 1 mg/mL Solution/ Drops?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Eye Allergy Itch and Redness Relief 1 mg/mL 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 —
Eye Allergy Itch and Redness Relief 1 mg/mL 70677-1156-01 Strategic 1 bottle $1.268 — Availability likely —
Olopatadine Hydrochloride 1 mg/mL 00536-1445-40 RUGBY 1 bottle $1.274 — Availability likely —
olopatadine hydrochloride 1 mg/mL 16571-0882-05 Rising 5 ml $1.274 — Availability likely —
Olopatadine Hydrochloride Ophthalmic 1 mg/mL 43598-0765-07 Dr. 1 bottle $1.274 — Availability likely —
Olopatadine Hydrochloride 1 mg/mL 46122-0672-64 Amerisource 1 bottle $1.274 — Availability likely —
Leader Olopatadine Hydrochloride Ophthalmic Solution 1 mg/mL 70000-0717-01 CARDINAL 1 bottle $1.274 — Availability likely —
Olopatadine 1 mg/mL 70069-0017-01 Somerset 1 bottle $1.274 — Availability likely —
Olopatadine Hcl 1 mg/mL 70512-0520-05 Sola 1 bottle $1.274 — Availability likely —
Olopatadine Hydrochloride 1 mg/mL 70677-1280-01 Strategic 1 bottle $1.274 — Availability likely —
Pataday Twice A Day Relief 1 mg/mL 00065-4274-01 Alcon 1 bottle $2.482 — Availability likely —
Olopatadine Hydrochloride 1 mg/mL 62332-0501-05 Alembic 1 bottle $3.065 — FDA listed —
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/mLthis 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

🏛️
2025
On the market since
May 2025
📍
2026
Currently FDA-listed
1 year 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.

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 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 94255I6E2T
    Sodium phosphate dibasic dihydrate is a salt that helps control the acidity level of a medicine. It acts as a buffer and pH regulator to keep the medication stable and effective.
  • 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%, hydrochloric acid/sodium hydroxide (adjust pH), sodium phosphate dibasic (anhydrous), 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.

Manufacturer & labeler

LabelerAllegiant Health
Application holderAPOTEX INC
FDA applicationANDA078350 (ANDA)
Labeler code69168
First marketedMay 2025
Product typeHuman Otc Drug
Portfolio113 products on file

More NDCs from Allegiant Health labeler code 69168

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 16 words ▾

Use(s) Temporarily relieves itchy and red eyes due to pollen, ragweed, grass, animal hair and dander.

⏱️ Dosage and Administration 60 words ▾

Directions adults and children 2 years 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 122 words ▾

Warnings For external use only Do not use if you have 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 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 If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 9 words ▾

Active ingredient(s) Olopatadine (01.%) (equivalent to olopatadine hydrochloride 0.111%)

🧪 Inactive Ingredients 20 words ▾

Inactive ingredients benzalkonium chloride 0.01%, hydrochloric acid/sodium hydroxide (adjust pH), sodium phosphate dibasic (anhydrous), sodium chloride and water for injection.

🎯 Purpose 5 words ▾

Purpose Antihistamine and redness reliever

📄 Do Not Use 29 words ▾

Do not use if you have 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 43 words ▾

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 26 words ▾

Stop use and ask a doctor if 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 10 words ▾

Questions/Comments Call 1-888-952-0050 (Monday-Friday 9 AM – 5 PM EST)

📄 Package Label / Principal Display Panel 15 words ▾

Principal Display Panel Eye Relief, Label Eye Relief, Carton Eye Relief, Label Eye Relief, Carton

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

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 — Not published for this NDC No photo available yet for this listing.
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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

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 Allegiant Health. 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 1 other package presentation of this same product, including 1 bottle (69168-0480-65). 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?
Allegiant Health is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 69168-0479-64 · Allegiant 69168-0481-07 · Allegiant →
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.