FDA.reportPublic FDA data

PCXX ONE MINTE GEL BANANA BERRY

Manufacturer
Ross Healthcare Inc.
Effective date
2014-05-21
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 20:18:48

Label at a glance#

ProductPCXX ONE MINTE GEL BANANA BERRY
Active ingredientSODIUM FLUORIDE
Label structure2 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PCXX ONE MINUTE BANANA BERRY FRONT PANELPCXX ONE MINUTE BANANA BERRY FRONT PANEL

WARNINGS AND PRECAUTIONS SECTION

PCXX ONE MINUTE BANANA BERRY SECONDARY PANELPCXX ONE MINUTE BANANA BERRY SECONDARY PANEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62007-001-162020-01-31C16284748780-19d75b9d0-d342-f424-e053-dadaa90a57ce7372f0a7-5093-44e1-b17d-e5704ee9c238

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62007-001-16PCXX ONE MINTE GEL BANANA BERRY1 mg in 1 BOTTLE, PLASTICGEL12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62007-001PCXX ONE MINTE GEL BANANA BERRY (FLUORIDE TREATMENT) GEL [ROSS HEALTHCARE INC.]2Legacy NDC, 1 package rows20140530_7372f0a7-5093-44e1-b17d-e5704ee9c238.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W72
FLUORIDE IONACTIVE MOIETYQ80VPU408O2

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62007-00162007-001-16

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
SODIUM FLUORIDE8ZYQ1474W7ACTIM

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
7eab8df6-d52e-4c6d-b41b-ed90d498e3fa7372f0a7-5093-44e1-b17d-e5704ee9c2382014-05-21WarningsExact identifier
spl id: 7eab8df6-d52e-4c6d-b41b-ed90d498e3fa
spl set id: 7372f0a7-5093-44e1-b17d-e5704ee9c238

Reported adverse events (FAERS/openFDA)#

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