FDA.reportPublic FDA data

PCXX RASPBERRY NEUTRAL GL

Product NDC
62007-826
11-digit product format
620070826
Labeler code
62007
Product ID
62007-826_3b5b565c-42b8-1ef0-e063-6294a90aea86
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 RASPBERRY 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
8296928e-8e4c-0e31-e053-2a91aa0ad694Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62007-826-16PCXX RASPBERRY NEUTRAL GL473 mL in 1 BOTTLE, PLASTICGEL4736

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62007-826PCXX RASPBERRY NEUTRAL GL (SODIUM FLUORIDE) GEL [ROSS HEALTHCARE INC.]5Current NDC, Legacy NDC, 1 package rows20250201_8296928e-8e4c-0e31-e053-2a91aa0ad694.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 RASPBERRY NEUTRAL GLSODIUM FLUORIDERoss Healthcare Inc.8296928e-8e4c-0e31-e053-2a91aa0ad6942025-08-02Exact identifier
ndc (product): 62007-826

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
245593sodium fluoride 2 % Dental GelPSN8296928e-8e4c-0e31-e053-2a91aa0ad6946
245593sodium fluoride 0.02 MG/MG Oral GelSCD8296928e-8e4c-0e31-e053-2a91aa0ad6946
245593sodium fluoride 2 % (fluoride ion 1.23 % ) Dental GelSY8296928e-8e4c-0e31-e053-2a91aa0ad6946
245593sodium fluoride 2.09 % (fluoride ion 1.23 % ) Dental GelSY8296928e-8e4c-0e31-e053-2a91aa0ad6946

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62007-826-1662007082616473 mL in 1 BOTTLE, PLASTIC (62007-826-16) 473 ml2019-02-220000-00-00NoNoCurrent