PCXX CREME DE MENTHE APF G

Product NDC
62007-806
11-digit product format
620070806
Labeler code
62007
Product ID
62007-806_42f10b82-dfd8-d798-e063-6394a90a7f61
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
2019-02-04
Substance
SODIUM FLUORIDE
Active strength
27.2 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
PCXX CREME DE MENTHE APF G
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE27.2 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
1535362Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8281bc97-3816-8653-e053-2991aa0a0f50Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2021-01-31PCXX CREME DE MENTHE APF GEL
2021-01-31PCXX CREME DE MENTHE APF GEL
2021-01-29PCXX CREME DE MENTHE APF GEL
2021-01-29PCXX CREME DE MENTHE APF GEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62007-806-16PCXX CREME DE MENTHE APF G473 mL in 1 BOTTLE, PLASTICGEL4736

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62007-806PCXX CREME DE MENTHE APF G (SODIUM FLUORIDE) GEL [ROSS HEALTHCARE INC.]5Current NDC, Legacy NDC, 1 package rows20250201_8281bc97-3816-8653-e053-2991aa0a0f50.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 CREME DE MENTHE APF GSODIUM FLUORIDERoss Healthcare Inc.8281bc97-3816-8653-e053-2991aa0a0f502025-11-06Exact identifier
ndc (product): 62007-806

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1535362sodium fluoride 2.72 % Oral GelPSN8281bc97-3816-8653-e053-2991aa0a0f506
1535362sodium fluoride 0.0272 MG/MG Oral GelSCD8281bc97-3816-8653-e053-2991aa0a0f506
1535362sodium fluoride 2.72 % (fluoride ion 1.23 % ) Oral GelSY8281bc97-3816-8653-e053-2991aa0a0f506

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62007-806-1662007080616473 mL in 1 BOTTLE, PLASTIC (62007-806-16) 473 ml2019-02-040000-00-00NoNoCurrent