PCXX ANTICARIES NO FLAVOR NE G

Product NDC
62007-835
11-digit product format
620070835
Labeler code
62007
Product ID
62007-835_3dfe9069-5287-412c-e063-6394a90aaaa7
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
2019-02-23
Substance
SODIUM FLUORIDE
Active strength
11.1 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 ANTICARIES NO FLAVOR NE G
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE11.1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui1486566

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62007-835-162021-01-31C16284748780-1ba0f9c33-1a4e-a910-e053-dadaa90a0b85PCXX ANTICARIES NO FLAVOR NE G
62007-835-162021-01-29C16284748780-1ba0f9c33-1a4e-a910-e053-dadaa90a0b85PCXX ANTICARIES NO FLAVOR NE G

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62007-835-16PCXX ANTICARIES NO FLAVOR NE G473 mL in 1 BOTTLE, PLASTICGEL4736

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62007-835PCXX ANTICARIES NO FLAVOR NE G (SODIUM FLUORIDE) GEL [ROSS HEALTHCARE INC.]5Current NDC, Legacy NDC, 1 package rows20250201_8296923b-a0a9-3bc8-e053-2991aa0a015a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1486566sodium fluoride 1.1 % Oral GelPSN8296923b-a0a9-3bc8-e053-2991aa0a015a6
1486566sodium fluoride 0.011 MG/MG Oral GelSCD8296923b-a0a9-3bc8-e053-2991aa0a015a6
1486566sodium fluoride 1.1 % Oral GelSY8296923b-a0a9-3bc8-e053-2991aa0a015a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62007-835-1662007083516473 mL in 1 BOTTLE, PLASTIC (62007-835-16) 473 ml2019-02-230000-00-00NoNoCurrent