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Prescription medicine

Brilliant blue g

Drug class: Disclosing Agent

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

Quick answers

What is Brilliant blue g used for?
The FDA-approved label (Tissueblue, D.O.R.C. Dutch Ophthalmic Research Center (International) B.V., April 17, 2026) says: “TissueBlue 0.025% is indicated to selectively stain the internal limiting membrane (ILM). TissueBlue 0.025% is a disclosing agent indicated to selectively stain the internal limiting membrane (ILM).” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Brilliant blue g have a boxed warning?
No. None of the 1 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Brilliant blue g?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Brilliant blue g been recalled?
No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
Who makes Brilliant blue g?
1 company lists prescription products of Brilliant blue g in the FDA NDC Directory, including D.O.R.C. Dutch Ophthalmic Research Center (International) B.V..

What Brilliant blue g is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

TissueBlue 0.025% is indicated to selectively stain the internal limiting membrane (ILM). TissueBlue 0.025% is a disclosing agent indicated to selectively stain the internal limiting membrane (ILM).

— FDA label: Tissueblue, D.O.R.C. Dutch Ophthalmic Research Center (International) B.V., effective April 17, 2026. Read the full label on DailyMed →

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

Forms and how it is given

Dosage formsInjection, solution
RouteIntraocular · Ophthalmic
Prescription products1 in the FDA NDC Directory
Brand namesTissueblue

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

FDA approval history

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA209569
TISSUEBLUE
Dutch OphthalmicDecember 20, 2019 2, latest April 4, 2025
2025: Labeling · 2022: Labeling

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.

Official identifiers

SPL set ID of the quoted label9d4b28b4-c582-4e2c-abd9-f7e203378e2d
FDA labels (SPL)1
FDA applicationsNDA209569
Active ingredients (FDA)BRILLIANT BLUE G

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Tissueblue, D.O.R.C. Dutch Ophthalmic Research Center (International) B.V., effective April 17, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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