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 Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui245593

FDA-Initiated Inactive NDC Indexing#

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

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