FDA.reportPublic FDA data

BRIMONIDINE TARTRATE 0.25% / POTASSIUM AZELOYL DIGLYCINATE 8%

Manufacturer
Sincerus Florida, LLC
Effective date
2019-05-15
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:28:45

Label at a glance#

ProductBRIMONIDINE TARTRATE 0.25% / POTASSIUM AZELOYL DIGLYCINATE 8%
Active ingredientBRIMONIDINE TARTRATE
Label structure4 sections

Label contents#

Full prescribing information#

Directions for use

INSTRUCTIONS FOR USE SECTION

dsds

Sincerus Florida, LLC. Advese reactions

ADVERSE REACTIONS SECTION

dd

Active, inactive

COMPONENTS

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NDC 72934- 1027-2 BRIMONIDINE TARTRATE USP 0.25% . Gel 30gm

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

dd

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BRIMONIDINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20230503

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6c0c444-a6ba-2fb5-a7bc-7f0443fa5791Product name420251208
8ec6541e-9842-115f-62bf-f7c9ab3aeddbProduct name320250805
39b7fcf4-8865-6d40-d24d-9b8c28bd6345Product name520250123
c93ffd9a-5bad-44d8-b5e5-16ef4d2fee72Product name120220316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72934-1027-22021-01-29C16284748780-1ba0f9c33-4f64-a910-e053-dadaa90a0b85BRIMONIDINE TARTRATE 0.25% / POTASSIUM AZELOYL DIGLYCINATE 8%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72934-1027-2BRIMONIDINE TARTRATE 0.25% / POTASSIUM AZELOYL DIGLYCINATE 8%30 g in 1 BOTTLE, PUMPGEL301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72934-1027BRIMONIDINE TARTRATE 0.25% / POTASSIUM AZELOYL DIGLYCINATE 8% GEL [SINCERUS FLORIDA, LLC]1Legacy NDC, 1 package rows20190516_88ef2cc1-1855-9606-e053-2995a90a2e67.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72934-102772934-1027-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
BRIMONIDINE TARTRATE4S9CL2DY2HACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
88ef2cc1-1856-9606-e053-2995a90a2e6788ef2cc1-1855-9606-e053-2995a90a2e672019-05-15Adverse reactionsExact identifier
spl id: 88ef2cc1-1856-9606-e053-2995a90a2e67
spl set id: 88ef2cc1-1855-9606-e053-2995a90a2e67

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.