FDA.reportPublic FDA data

PCXX VANILLA ORANGE NEUTRAL GL

Product NDC
62007-823
11-digit product format
620070823
Labeler code
62007
Product ID
62007-823_42f503c8-9363-5d88-e063-6294a90a1e15
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
GEL
Route
DENTAL; TOPICAL
Labeler
Ross Healthcare Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2019-02-22
Substance
SODIUM FLUORIDE
Active strength
20 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PCXX VANILLA ORANGE NEUTRAL GL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
245593Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
82978289-4943-83b1-e053-2991aa0a6365Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2021-01-31PCXX VANILLA ORANGE NEUTRAL GEL
2021-01-31PCXX VANILLA ORANGE NEUTRAL GEL
2021-01-29PCXX VANILLA ORANGE NEUTRAL GEL
2021-01-29PCXX VANILLA ORANGE NEUTRAL GEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62007-823-16PCXX VANILLA ORANGE NEUTRAL GL473 mL in 1 BOTTLE, PLASTICGEL4736

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62007-823PCXX VANILLA ORANGE NEUTRAL GL (SODIUM FLUORIDE) GEL [ROSS HEALTHCARE INC.]5Current NDC, Legacy NDC, 1 package rows20250201_82978289-4943-83b1-e053-2991aa0a6365.zip

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
PCXX VANILLA ORANGE NEUTRAL GLSODIUM FLUORIDERoss Healthcare Inc.82978289-4943-83b1-e053-2991aa0a63652025-11-06Exact identifier
ndc (product): 62007-823

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
245593sodium fluoride 2 % Dental GelPSN82978289-4943-83b1-e053-2991aa0a63656
245593sodium fluoride 0.02 MG/MG Oral GelSCD82978289-4943-83b1-e053-2991aa0a63656
245593sodium fluoride 2 % (fluoride ion 1.23 % ) Dental GelSY82978289-4943-83b1-e053-2991aa0a63656
245593sodium fluoride 2.09 % (fluoride ion 1.23 % ) Dental GelSY82978289-4943-83b1-e053-2991aa0a63656

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62007-823-1662007082316473 mL in 1 BOTTLE, PLASTIC (62007-823-16) 473 ml2019-02-220000-00-00NoNoCurrent