PCXX GRAPE APF G

Product NDC
62007-812
11-digit product format
620070812
Labeler code
62007
Product ID
62007-812_42f4960d-f29a-d25e-e063-6394a90aa243
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

Additional Listing Data#

Finished product
Yes
Brand name base
PCXX GRAPE APF G
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE27.2 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui1535362

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62007-812-16PCXX GRAPE APF G473 mL in 1 BOTTLE, PLASTICGEL4736

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62007-812PCXX GRAPE APF G (SODIUM FLUORIDE) GEL [ROSS HEALTHCARE INC.]5Current NDC, Legacy NDC, 1 package rows20250201_82872a07-04b7-5263-e053-2a91aa0aa2c2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1535362sodium fluoride 2.72 % Oral GelPSN82872a07-04b7-5263-e053-2a91aa0aa2c26
1535362sodium fluoride 0.0272 MG/MG Oral GelSCD82872a07-04b7-5263-e053-2a91aa0aa2c26
1535362sodium fluoride 2.72 % (fluoride ion 1.23 % ) Oral GelSY82872a07-04b7-5263-e053-2a91aa0aa2c26

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62007-812-1662007081216473 mL in 1 BOTTLE, PLASTIC (62007-812-16) 473 ml2019-02-040000-00-00NoNoCurrent