PCXX GRAPE APF F

Manufacturer
Ross Healthcare Inc.
Effective date
2025-01-30
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 21:24:39

Label at a glance#

ProductPCXX GRAPE APF F
Active ingredientSODIUM FLUORIDE
Label structure2 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

Shake well before use. This is a one minute or four minute fluoride gel for in-office patient use. It is normally used as a preventative caries treatment two times a year.

1. After thorough prophylaxsis, fill two single or one dual tray, one third full with gel. Air dry teeth and insert trays into the mouth.

2. Instruct patient to bite down lightly but firmly for one minute (80% effectiveness) or four minutes (100% effectiveness).

3. Remove trays. Instruct patient to expectorate any excess gel and not to eat or drink for at least 30 minute

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

principal display panelprincipal display panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
248389sodium fluoride 2.72 % Oral FoamPSN6
248389sodium fluoride 27.2 MG/ML Oral FoamSCD6
248389sodium fluoride 2.72 % (fluoride ion 1.23 % ) Oral FoamSY6
248389sodium fluoride 2.72 % Oral FoamSY6

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62007-053-072021-01-31C16284748780-1ba0f9c33-1a5a-a910-e053-dadaa90a0b85PCXX GRAPE APF F
62007-053-072021-01-29C16284748780-1ba0f9c33-1a5a-a910-e053-dadaa90a0b85PCXX GRAPE APF F

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62007-053-07PCXX GRAPE APF F125 g in 1 CANAEROSOL, FOAM1256

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62007-053PCXX GRAPE APF F (SODIUM FLUORIDE) AEROSOL, FOAM [ROSS HEALTHCARE INC.]6Legacy NDC, 1 package rows20250201_5e84d595-9eaf-7d80-e053-2991aa0a9eaa.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
62007-05362007-053-07

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
2cf68d22-215b-aced-e063-6394a90ab0b55e84d595-9eaf-7d80-e053-2991aa0a9eaa2025-01-30Exact identifier
spl id: 2cf68d22-215b-aced-e063-6394a90ab0b5
spl set id: 5e84d595-9eaf-7d80-e053-2991aa0a9eaa

Reported adverse events (FAERS/openFDA)#

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