What this pack is
Restasis is the brand name in this record; cyclosporine ophthalmic emulsion is the generic name. Read both together with the dosage form (ophthalmic product).
PACK CHECK · MARKET FIRST
RestasisGeneric namecyclosporine ophthalmic emulsion
How this medicine works
The DailyMed label describes RESTASIS as a topical immunomodulator with anti-inflammatory effects and says it is thought to act as a partial immunomodulator in the labelled dry-eye context, while the exact mechanism is not known. This explains the label's pharmacologic boundary; it does not determine anyone's cause of dry eye, suitability, drop count, combination or switching plan.
Read source: United States ↗reviewed 2026-08-20More about its action and precautions →Check the market, names, dosage form and route together
A medicine may use different brand names across markets. Keep the market, brand, generic name, dosage form and route together; one matching field does not prove that two packs are the same or interchangeable.
Open the complete product-identity record
Use these fields when the pack, market name or package image needs closer checking. They are evidence boundaries, not substitution instructions.
- International brand name
- Restasis
- Generic name
- cyclosporine ophthalmic emulsion
- Dosage-form class
- Ophthalmic emulsion: 0.05% (0.5 mg/mL); exact 30- and 60-single-use-vial carton panels are displayed; RESTASIS MULTIDOSE 5.5 mL bottle is not merged into this dossier
- Route
- Ophthalmic use
- Package-image status
- A source-linked public label image is available below
No source-verifiable mainland-China trade-name cue has been established for this record. This does not establish whether the medicine exists, is approved or is available in mainland China. Check pack text and current CDE/NMPA records item by item.
FOR EVERYDAY QUESTIONS
After the leaflet, continue with the question you still need to check
What this page can show
This is a source-traceable public record. It helps you read the product identity and its listed source documents; each market still needs its own current record check.
What to bring to the next conversation
Bring the actual pack, the label or prescription, and a complete medicine list when you speak with a pharmacist or clinician.
NEXT SAFE STEP
Choose the next safe check
A question about changing, combining or splitting?Put the exact packs on one list before a pharmacist or prescriber checks the full context.Open the family medicine list →A question about cost, reimbursement or availability?First lock the market, exact presentation and date. Use local official reimbursement, hospital or pharmacy channels for a current answer rather than a web estimate.Open regulator and market-record entry points →Unsure about a pack or a cross-border product?Photo reading can return possible record matches only. Check the actual product against the current regulator record for its market.Identify pack text locally →Saw a recall, approval or procurement headline?Open the original publisher, then match its product, market and date. Do not make a stop or switch decision from a headline.Read primary-source news →
PRODUCT PRESENTATION IDENTITY
Strength, pack and device identity
A percentage or mg/mL describes the labelled concentration of this exact eye product. It does not calculate an individual's number of drops, timing, missed-use action, combination or switch.
2 source-backed strength, pack or device records — open the full list
First match the market, dosage form and labelled amount on the pack in hand. The number of tablets, sachets or devices in a pack is not a personal dose or schedule.
United States label · DailyMed updated 9 Sep 2024; SPL v19 published 30 Dec 2024
0.05% (0.5 mg/mL); 0.4 mL per single-use vial; 30-vial carton
- Product code
- NDC 0023-9163-30
- Form and route
- cyclosporine ophthalmic emulsion (single-use vial) · ophthalmic use (label product-identity field only)
- Labelled concentration
- 0.5 mg/mL (0.05%; labelled concentration)Product identity, not an individual dose
- Container
- single-use vial · 0.4 mL
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-21; actual marketing, stock and availability are not established.
- cyclosporine
- 0.5 mglabelled concentration; not an individual drop count, frequency, after-opening handling or conversion instruction
- Package
- 30 × single-use vials per carton
United States label · DailyMed updated 9 Sep 2024; SPL v19 published 30 Dec 2024
0.05% (0.5 mg/mL); 0.4 mL per single-use vial; 60-vial carton
- Product code
- NDC 0023-9163-60
- Form and route
- cyclosporine ophthalmic emulsion (single-use vial) · ophthalmic use (label product-identity field only)
- Labelled concentration
- 0.5 mg/mL (0.05%; labelled concentration)Product identity, not an individual dose
- Container
- single-use vial · 0.4 mL
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-21; actual marketing, stock and availability are not established.
- cyclosporine
- 0.5 mglabelled concentration; not an individual drop count, frequency, after-opening handling or conversion instruction
- Package
- 60 × single-use vials per carton
PUBLIC LABEL IMAGE
Appearance and package-text clues
This current public-label package panel helps check the brand, generic name, strength and dosage-form clues only. It does not authenticate a product in hand or establish originator status, availability, sale eligibility, another package or another market.
Open the public label source ↗LABEL READING · NOT A PRESCRIPTION
RESTASIS label reading: 0.05%, 0.5 mg/mL and single-use vials are identity clues checked together
Reading level: drug-specific label reading. This record has been expanded around its dosage form or a higher-risk reading question; the current target-market label and professional review still apply.
This module uses the U.S. DailyMed public label to check RESTASIS, cyclosporine ophthalmic emulsion, 0.05%/0.5 mg/mL, the exact 30- or 60-single-use-vial carton panels with 0.4 mL per vial, and ophthalmic use. It does not provide an individual's drop count, timing, after-opening handling, missed-use, combination, switching or dry-eye treatment plan.
- 0.05% and 0.5 mg/mL are two label formats for the concentration of this ophthalmic emulsion; 60 single-use vials identify the package on this exact carton. They help identify what is being read, not calculate anyone's drop count, daily timing, after-opening handling or how long a pack lasts.
- RESTASIS and RESTASIS MULTIDOSE are not packaging forms this page can automatically merge, substitute or convert merely from a shared brand or generic name. The ophthalmic-emulsion container, single- versus multiple-use information, label version and target market must each be checked against the current label for the exact product in hand and professional guidance.
- The package image, NDC, concentration and single-use wording only help compare a source. They cannot authenticate a medicine, identify another cyclosporine eye product or confirm current handling, storage, contact-lens or other-eye-drop requirements. Those questions must follow the current label and professional instructions for the exact product in hand.
- The label calls for care around eye irritation/burning, eye infection or injury. With vision change, marked eye pain, redness/swelling, injury, discharge change or another acute eye concern, use local ophthalmic or urgent-care pathways promptly; this page does not decide self-continuation, pause or switching.
PHARMACOVIGILANCE · OFFICIAL ROUTES
Check safety information in the right market
Start with the public label or product record linked to this dossier, then use the official safety routes below for the market that applies to the medicine in hand.
Match five details before using a safety record
- Brand and generic nameBoth must match the medicine named by the record.
- Dosage form and strengthTablet, capsule, injection, inhaler, patch and eye drop are not interchangeable.
- Market and notice dateA record applies only to the country or region and date it names.
- Lot, pack and manufacturerRecord these only when the official notice specifically names them.
- Current product informationA historical record may have been superseded by the current label.
This checklist only helps organise the right question. It does not create a personal conclusion about stopping, switching, dose, combination or suitability.
This dossier’s product-level source checkU.S. National Library of Medicine DailyMed · United States · Public medicine label · 2026-08-20
This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk.
Markets actually represented by the reviewed product documents
- United States · 1
This is a document-coverage summary, not a claim that the medicine is authorised, supplied, interchangeable or actively monitored in every listed market today.
This record’s label or product-record routeDailyMed (NLM): RESTASIS cyclosporine ophthalmic-emulsion public label (Allergan, Sep 2024 update; marketing application NDA050790) ↗reviewed 2026-08-20
This is not a conclusion that the medicine has no risk, warning, recall or newer notice in another market. Start with the checked product-level label above, then use the official market gateways below for the product in hand.
See the reviewed safety-record directory →Global official safety gateways
- NMPA Centre for Drug Reevaluation · Mainland ChinaPrimary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item.Drug-vigilance bulletins and safety notices ↗reviewed 2026-08-22
- FDA · United StatesPrimary FDA pages for important new safety issues, labelling changes and risk communications.Drug Safety Communications ↗reviewed 2026-08-22
- FDA MedWatch · United StatesU.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality.Safety information and serious-problem reporting ↗reviewed 2026-08-22
- EMA · European Union / European Economic AreaOfficial EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment.Pharmacovigilance overview and EudraVigilance ↗reviewed 2026-08-22
- MHRA · United KingdomPrimary UK MHRA medicine-safety updates for professionals and the public.Drug Safety Update ↗reviewed 2026-08-22
- PMDA · JapanPMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents.Medicine safety information ↗reviewed 2026-08-22
- MFDS · Republic of KoreaMFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case.Medicine safety letters ↗reviewed 2026-08-22
- HSA · SingaporeHSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information.Adverse-event reporting and medicine-safety information ↗reviewed 2026-08-22
- Health Canada · CanadaHealth Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item.MedEffect Canada: advisories, warnings and recalls ↗reviewed 2026-08-22
- TGA · AustraliaPrimary Australian TGA safety alerts, advisories and monitoring information for therapeutic products.Medicine safety alerts ↗reviewed 2026-08-22
- Swissmedic · SwitzerlandOfficial Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality.Pharmacovigilance and suspected adverse-reaction reporting ↗reviewed 2026-08-22
- Medsafe · New ZealandNew Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information.Medicine safety communications ↗reviewed 2026-08-22
- SAHPRA · South AfricaSAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information.Medicine safety information, alerts and pharmacovigilance ↗reviewed 2026-08-22
- WHO · GlobalWHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market.Medicine and vaccine safety-alert archive ↗reviewed 2026-08-22
- Anvisa · BrazilAnvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item.Pharmacovigilance, alerts and VigiMed ↗reviewed 2026-08-22
This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline.
For severe or rapidly worsening symptoms, suspected overdose, a severe allergic reaction, loss of consciousness or another emergency, use local emergency services. Do not wait for an online alert search or change a medicine from this page.
PRIVATE FAMILY LIST
Bring this record into a local medicine list
Only the brand, generic name, dosage form and route are added, and they stay in this browser. Copy strength, label directions, start/stop history and any concern from the actual pack; this tool does not calculate a dose or decide combination, switching or stopping.
Add to the family medicine list →PACK · LABEL · MEDICINE LIST
Six checks for this medicine pack
Use this card to organise questions about Restasis (cyclosporine ophthalmic emulsion). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
Restasis is the brand in this record and cyclosporine ophthalmic emulsion is the active-ingredient name. Check both with the dosage form (Ophthalmic emulsion: 0.05% (0.5 mg/mL); exact 30- and 60-single-use-vial carton panels are displayed; RESTASIS MULTIDOSE 5.5 mL bottle is not merged into this dossier) and the market on the actual pack.
Read the labelled strength in context
A percentage, mg/mL or pack volume describes the labelled eye-product identity. It is not an individual drop count, frequency or after-opening instruction.
Check the exact eye product
For an eye product, verify the exact concentration, bottle and current label. Do not transfer liquid between containers or treat a similar name as proof that products are interchangeable.
Put every product on one list
Include prescriptions, over-the-counter products, eye drops, creams, vitamins, minerals, herbs and supplements. A pharmacist or prescriber needs the whole list before any combination, alternation, switch or stop is considered.
Ask a specific pharmacogenetics question
Ask which medicine, which gene and what clinical decision a result could change. A gene–drug association does not mean broad genetic testing is needed for everyone and must not be used to change treatment without professional review.
Know when to seek urgent help
For a suspected overdose, a severe allergic reaction, fainting or difficulty breathing, use the local emergency or poison-information service now. Do not wait for a website reply or alter several medicines to test what caused it.
This card does not calculate a dose, decide whether medicines can be combined, or replace a clinician or pharmacist. Market-specific current labels and the person's full context still need review.
HOW IT WORKS · NOT A TREATMENT PLAN
How cyclosporine ophthalmic emulsion works: the label describes local immunomodulation and says the exact mechanism is not known
- “Immunomodulation” and “anti-inflammatory” describe a labelled action pathway; they do not determine a need for this product from dryness, stinging, red eye or one examination result. Symptom cause, ocular-surface examination, prior eye conditions, other drops and the current target-market label need joint ophthalmic review.
- Sharing cyclosporine or an immune/ocular-inflammation context does not prove that oral cyclosporine, another eye product or another dry-eye product can be self-combined, alternated, substituted or concentration-converted. Dosage form, route, risks, the complete eye/systemic medicine list and actual packages must be checked item by item.
- A mechanism page cannot manage sudden vision change, marked pain, injury, infection concern, before/after procedures or uncertainty about the exact container. With an acute or serious eye concern, prioritise local ophthalmic and urgent medical support rather than self-adjusting from this page.
SOURCE EVIDENCE REGISTER
Source evidence map
Every public link is labelled with its market, document status and document type. A historical public record is not a current label, and an official lookup entry is not a product-specific record.
- DailyMed (NLM): RESTASIS cyclosporine ophthalmic-emulsion public label (Allergan, Sep 2024 update; marketing application NDA050790) ↗reviewed 2026-08-20
- FDA: RESTASIS original approval letter (NDA 21-023; 23 Dec 2002) ↗Historical public record · reviewed 2026-08-20
- DailyMed (NLM): separate U.S. RESTASIS MULTIDOSE public label (package-distinction source only) ↗reviewed 2026-08-20
- FDA Drugs@FDA official search entry ↗Official lookup entry · reviewed 2026-08-20
SOURCE-TRACEABLE ARCHIVE
Restasiscyclosporine ophthalmic emulsion
This page includes an exact current U.S. public-label package panel for Restasis, alongside documentary primary-source material. It helps check product identity, but does not itself establish originator status, product quality, availability or sale eligibility.
DOCUMENT TIMELINE
Document timeline
Original U.S. RESTASIS approval
FDA's original approval letter records approval of RESTASIS (cyclosporine ophthalmic emulsion 0.05%) under NDA 21-023 on 23 Dec 2002. The current DailyMed label separately lists marketing application NDA050790; the two identifiers are not interchangeable. This historical node does not establish approval, supply or sale status in another market.
FDA: RESTASIS original approval letter (NDA 21-023; 23 Dec 2002) ↗Current DailyMed label page updated
The current DailyMed RESTASIS label page lists an update on 9 Sep 2024; this page does not interpret that date as an individual-use, availability or supply conclusion.
Primary-source record (open linked document) ↗Current SPL v19 published on DailyMed
The DailyMed media listing shows the current RESTASIS SPL v19 published on 30 Dec 2024. That date does not represent individual use, package availability or another-market status.
DailyMed (NLM): current U.S. RESTASIS public label and exact 60-single-use-vial carton panel (Allergan; SPL v19, published 30 Dec 2024) ↗
MARKET SCOPE
Market-record boundary
United States
Current label, FDA original-approval material and two exact single-use carton panels linkedThe two display panels correspond only to 0.05% (0.5 mg/mL), 0.4 mL per vial, NDC 0023-9163-30 (30 vials) and NDC 0023-9163-60 (60 vials); they do not establish actual marketing, stock, individual handling or RESTASIS MULTIDOSE status.
Mainland China, EU, Japan and other markets
Market record not establishedNo local trade name, approval, pack, supply, originator relationship or interchangeability is inferred from the U.S. label.
How to read this record
Read each document in its stated market, date and dosage-form context. A historical record is not a current label and does not support individual medical, substitution or purchasing conclusions.
Keep international and mainland China records separate
This page has a U.S. public history/regulatory archive but no mainland China record for this specific product. That does not establish whether the medicine exists, is approved or is available in mainland China. Verify product identity, dosage form, strength, holder and the current label item by item.
RECORD FAQ
Record questions
Are 0.05% and 0.5 mg/mL two different concentrations?
No. They are two label formats for the concentration of this exact U.S. ophthalmic emulsion; that does not turn this page into anyone's drop-count, frequency, after-opening-handling or conversion calculator.
Can RESTASIS and RESTASIS MULTIDOSE be interchanged from the brand name alone?
No. A shared brand or generic name is insufficient to determine container, single- versus multiple-use information, label, package or actual handling requirements. Have a professional review the exact product in hand and the complete eye/systemic medicine list.
READ NEXT
Related reading
Evidence status
The listed links are public sources selected for traceability. They must be rechecked against the current target-market record before any use beyond reading and research.