FDA.reportPublic FDA data

McKesson Fluoride

Product NDC
68599-0123
11-digit product format
685990123
Labeler code
68599
Product ID
68599-0123_b8e13ac8-cb70-fc2c-e053-2a95a90a7306
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Monofluorophosphate
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
McKesson Medical-Surgical
Application
part355
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-02-17
Marketing end
0000-00-00
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
2 mg/g
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68599-0123DDiscontinued by firm2026-10-05
excluded packagepackage68599-012368599-0123-1DDiscontinued by firm2026-10-05
excluded packagepackage68599-012368599-0123-2DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68599-0123-1McKesson Fluoride1 in 1 BOXPASTE, DENTIFRICE18
68599-0123-1McKesson Fluoride144 in 1 CARTONPASTE, DENTIFRICE1448
68599-0123-2McKesson Fluoride1 in 1 BOXPASTE, DENTIFRICE18
68599-0123-2McKesson Fluoride144 in 1 CARTONPASTE, DENTIFRICE1448

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Sodium MonofluorophosphateACTIVE INGREDIENTC810JCZ56QMCKESSON FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MCKESSON MEDICAL-SURGICAL]2
Fluoride IonACTIVE MOIETYQ80VPU408OMCKESSON FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MCKESSON MEDICAL-SURGICAL]2
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKMCKESSON FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MCKESSON MEDICAL-SURGICAL]2
CarboxyMethylCelluloseINACTIVE INGREDIENT05JZI7B19XMCKESSON FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MCKESSON MEDICAL-SURGICAL]2
GlycerinINACTIVE INGREDIENTPDC6A3C0OXMCKESSON FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MCKESSON MEDICAL-SURGICAL]2
Hydrated SilicaINACTIVE INGREDIENTY6O7T4G8P9MCKESSON FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MCKESSON MEDICAL-SURGICAL]2
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYMCKESSON FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MCKESSON MEDICAL-SURGICAL]2
Sodium BenzoateINACTIVE INGREDIENTOJ245FE5EUMCKESSON FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MCKESSON MEDICAL-SURGICAL]2
Sodium Lauryl SulfateINACTIVE INGREDIENT368GB5141JMCKESSON FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MCKESSON MEDICAL-SURGICAL]2
SODIUM PYROPHOSPHATEINACTIVE INGREDIENTO352864B8ZMCKESSON FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MCKESSON MEDICAL-SURGICAL]2
SorbitolINACTIVE INGREDIENT506T60A25RMCKESSON FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MCKESSON MEDICAL-SURGICAL]2
WaterINACTIVE INGREDIENT059QF0KO0RMCKESSON FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MCKESSON MEDICAL-SURGICAL]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68599-0123MCKESSON FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MCKESSON MEDICAL-SURGICAL]8Legacy NDC, 4 package rows20241012_40057da9-2a4e-4bae-b5b4-606e9b757dc7.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68599-0123-168599012301144 BOX in 1 CARTON (68599-0123-1) > 1 TUBE in 1 BOX > 43 g in 1 TUBE144 box2012-02-170000-00-00NoNoCurrent
68599-0123-268599012302144 BOX in 1 CARTON (68599-0123-2) > 1 TUBE in 1 BOX > 78 g in 1 TUBE144 box2012-02-170000-00-00NoNoCurrent