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Olopatadine Hydrochloride Ophthalmic Solution 1 mg/mL Solution/ Drops — NDC 0536-1308-40 (Billing 00536-1308-40)

by Rugby Laboratories · 1 BOTTLE, PLASTIC in 1 CARTON / 5 mL in 1 BOTTLE, PLASTIC

This is a package of Olopatadine Hydrochloride Ophthalmic Solution 1 mg/mL Solution/ Drops from Rugby Laboratories, no longer marketed (first marketed Jan 2021), no longer in the FDA NDC Directory, this package's marketing ended Jun 2026; retail pharmacies pay about $1.22 per mL (NADAC). It is this product's only package size.

NDC 00536-1308-40
🏷️ FDA NDC (as labeled) 0536-1308-40 billing pads the labeler segment with a zero
OTC Generic Discontinued Non-controlled ⚠ Discontinued by firm ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 2, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

NDC database record

One package, one record: these facts belong to NDC 0536-1308-40 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0536 labeler · 1308 product · 40 package
Package marketed since
Jan 5, 2021
Package marketing ended
Jun 30, 2026
Sample package
No — commercial package
Barcode (UPC-A, from the NDC)
3 0536130840 7
Medicaid fills, this package
64,340 prescriptions in the last four reported quarters
FDA record last changed
Jul 2, 2026
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Jun 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0536-1308-40
Product NDC 0536-1308
11-digit billing NDC 00536130840
NCPDP billing unit ML — per mL (volume)
RxCUI 1111339
UNII 2XG66W44KF
Application # ANDA209619
SPL Set ID d7bcba63-bfaf-240b-199e-2e42a91c19c9
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 Discontinued
FDA listing status Discontinued by firm (certified through Jun 2026)
Marketing start 2021-01-05
Marketing end 2026-06-30
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance OLOPATADINE HYDROCHLORIDE

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

GPI-14 86802065102020
GPI class Olopatadine HCl
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 OLOPATADINE HCL 0.1% EYE DROPS
FDB brand name Olopatadine Hcl
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 030796
  • GCN: 68321
  • GPI-14 (Medi-Span): 86802065102020
  • HICL (First Databank): 012815
  • AHFS class code: 52:02.00.00
  • RxCUI (RxNorm): 1111339
Why two NDCs? The FDA registers this code as 0536-1308-40 — 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 → 00536-1308-40. 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 OLOPATADINE HCL 0.1% EYE 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 →
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 $1.223 $6.11 / 5 ml
Medicaid paysCMS SDUD · 12 mo $2.94 $14.72 / 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 Feb 2024 Jun 2026 $1.704 $1.165
▼ Down 18% over the last 21 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00536-1308-40 You're viewing this Main listing 1 BOTTLE, PLASTIC in 1 CARTON / 5 mL in 1 BOTTLE, PLASTIC 2021-01-05 Jun 30, 2026 Discontinued by firm

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 +0%
Olopatadine Hydrochloride Ophthalmic Solution 1 mg/mLthis 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 +4%
Olopatadine Hydrochloride 1 mg/mL 00536-1445-40 RUGBY 1 bottle $1.274 — Availability likely +4%
olopatadine hydrochloride 1 mg/mL 16571-0882-05 Rising 5 ml $1.274 — Availability likely +4%
Olopatadine Hydrochloride Ophthalmic 1 mg/mL 43598-0765-07 Dr. 1 bottle $1.274 — Availability likely +4%
Olopatadine Hydrochloride 1 mg/mL 46122-0672-64 Amerisource 1 bottle $1.274 — Availability likely +4%
Leader Olopatadine Hydrochloride Ophthalmic Solution 1 mg/mL 70000-0717-01 CARDINAL 1 bottle $1.274 — Availability likely +4%
Olopatadine 1 mg/mL 70069-0017-01 Somerset 1 bottle $1.274 — Availability likely +4%
Olopatadine Hcl 1 mg/mL 70512-0520-05 Sola 1 bottle $1.274 — Availability likely +4%
Olopatadine Hydrochloride 1 mg/mL 70677-1280-01 Strategic 1 bottle $1.274 — 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.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerRugby Laboratories
Application holderGLAND PHARMA LTD
FDA applicationANDA209619 (ANDA)
Labeler code00536
First marketedJan 2021
Product typeHuman Otc Drug
Portfolio149 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.

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 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

📄 Do Not Use 29 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 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 27 words ▾

STOP USE AND ASK 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.

📄 Other Information 18 words ▾

OTHER INFORMATION • only for use in the eye • store between 4° to 25°C (39° to 77°F)

📄 Questions or Comments 3 words ▾

QUESTIONS? Call 1-888-375-3784

📄 Package Label / Principal Display Panel 75 words ▾

PRINCIPAL DISPLAY PANEL NDC 0536-1308-40 NOW AVAILABLE without a prescription Twice Daily Relief Olopatadine HCl Ophthalmic Solution, USP, 0.1% Antihistamine and Redness Reliever Works in Minutes Relief from Allergens: • pet dander • pollen • grass • ragweed Twice Daily Sterile 5 mL Compare to active ingredient in Pataday Twice Daily Relief* Packaged with Tamper-Evident bottle cap. Do Not Use if breakable ring is separated or missing. For Ages 2 and Older 30 DAY SUPPLY

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
64.3K
Units reimbursed last 4 qtrs
338K
Gross reimbursed last 4 qtrs
$995K
Avg / prescription
$15.46
Avg / unit
$2.9434
Latest quarter Q1 2026
5.2KRx
Medicaid pays / mL
$2.9434
gross reimbursed
vs
NADAC / mL
$1.2228
acquisition cost
=
Spread
+$1.7206
+141% 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 ⓘ
76% FFS 24% MCO
Fee-for-service · 48,843 Rx Managed care · 15,497 Rx
State Medicaid map
Alaska: no data reported AK Maine: 1,945 units · 139 per 100k residents ME Washington: no data reported WA Idaho: 755 units · 38.4 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 5,545 units · 96.7 per 100k residents MN Wisconsin: 4,360 units · 73.8 per 100k residents WI Michigan: 5,273 units · 52.5 per 100k residents MI New York: 145,654 units · 744 per 100k residents NY Vermont: 515 units · 79.6 per 100k residents VT New Hampshire: 70 units · 5.0 per 100k residents NH Oregon: 780 units · 18.4 per 100k residents OR Nevada: 1,520 units · 47.6 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: 3,370 units · 49.1 per 100k residents IN Ohio: 11,395 units · 96.7 per 100k residents OH Pennsylvania: 25,014 units · 193 per 100k residents PA New Jersey: 7,907 units · 85.1 per 100k residents NJ Massachusetts: 60 units · 0.9 per 100k residents MA California: 88,160 units · 226 per 100k residents CA Utah: no data reported UT Colorado: 1,420 units · 24.2 per 100k residents CO Nebraska: 1,535 units · 77.6 per 100k residents NE Missouri: 4,365 units · 70.4 per 100k residents MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: 4,225 units · 48.5 per 100k residents VA Maryland: 3,426 units · 55.4 per 100k residents MD Connecticut: 4,320 units · 119 per 100k residents CT Rhode Island: 1,105 units · 101 per 100k residents RI Arizona: 740 units · 10.0 per 100k residents AZ New Mexico: no data reported NM Kansas: 2,185 units · 74.3 per 100k residents KS Arkansas: no data reported AR Tennessee: 1,820 units · 25.5 per 100k residents TN North Carolina: 2,230 units · 20.6 per 100k residents NC South Carolina: no data reported SC Delaware: 1,475 units · 143 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: 410 units · 3.7 per 100k residents GA D.C.: 485 units · 71.4 per 100k residents DC Hawaii: no data reported HI Texas: 4,080 units · 13.4 per 100k residents TX Florida: 1,905 units · 8.4 per 100k residents FL
Units reimbursed · per 100k residents
0.9744
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 744 /100k
2 California 226 /100k
3 Pennsylvania 193 /100k
4 Delaware 143 /100k
5 Maine 139 /100k
6 Connecticut 119 /100k
7 Rhode Island 101 /100k
8 Ohio 96.7 /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 Solution (this brand).

Top reported reactions

Treatment Failure1,933
Nausea117
Headache116
Diarrhoea114
Fatigue103
Pneumonia103
Pyrexia102

Reporter sex

4,003 reports
Male · 32%
Female · 68%
Unknown · 0%

Serious outcomes

Hospitalization774
Death192
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,938 132
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 No longer marketed (per FDA listing data)
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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) ✓ Available
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) ✓ 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

What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Who lists this product with the FDA?
Rugby Laboratories 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.
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.