SparkleFresh

Product NDC
53329-083
11-digit product format
533290083
Labeler code
53329
Product ID
53329-083_27d69435-782e-9b40-e063-6394a90a93f4
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Monofluorophosphate
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Medline Industries, LP
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2007-01-01
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
1 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SparkleFresh
Brand name suffix
Flouride Toothpaste
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM MONOFLUOROPHOSPHATE1 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiC810JCZ56Q
Rxcui545626

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-083-21SparkleFreshFlouride Toothpaste42.5 g in 1 TUBEPASTE, DENTIFRICE42.57
53329-083-92SparkleFreshFlouride Toothpaste17 g in 1 PACKETPASTE, DENTIFRICE177
53329-083-93SparkleFreshFlouride Toothpaste24 g in 1 PACKETPASTE, DENTIFRICE247
53329-083-94SparkleFreshFlouride Toothpaste78 g in 1 TUBEPASTE, DENTIFRICE787

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Sodium MonofluorophosphateACTIVE INGREDIENTC810JCZ56QSPARKLEFRESH FLUORIDE TOOTHPASTE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MEDLINE INDUSTRIES, INC.]1
Fluoride IonACTIVE MOIETYQ80VPU408OSPARKLEFRESH FLUORIDE TOOTHPASTE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MEDLINE INDUSTRIES, INC.]1
Calcium CarbonateINACTIVE INGREDIENTH0G9379FGKSPARKLEFRESH FLUORIDE TOOTHPASTE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MEDLINE INDUSTRIES, INC.]1
CarboxymethylcelluloseINACTIVE INGREDIENT05JZI7B19XSPARKLEFRESH FLUORIDE TOOTHPASTE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MEDLINE INDUSTRIES, INC.]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXSPARKLEFRESH FLUORIDE TOOTHPASTE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MEDLINE INDUSTRIES, INC.]1
Sodium BenzoateINACTIVE INGREDIENTOJ245FE5EUSPARKLEFRESH FLUORIDE TOOTHPASTE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MEDLINE INDUSTRIES, INC.]1
Sodium Lauryl SulfateINACTIVE INGREDIENT368GB5141JSPARKLEFRESH FLUORIDE TOOTHPASTE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MEDLINE INDUSTRIES, INC.]1
Sodium PyrophosphateINACTIVE INGREDIENTO352864B8ZSPARKLEFRESH FLUORIDE TOOTHPASTE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MEDLINE INDUSTRIES, INC.]1
SorbitolINACTIVE INGREDIENT506T60A25RSPARKLEFRESH FLUORIDE TOOTHPASTE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MEDLINE INDUSTRIES, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RSPARKLEFRESH FLUORIDE TOOTHPASTE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MEDLINE INDUSTRIES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-083SPARKLEFRESH FLOURIDE TOOTHPASTE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MEDLINE INDUSTRIES, LP]7Current NDC, Legacy NDC, 4 package rows20250108_1565528b-89f2-4c97-b294-15b6ebd3f80e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN1565528b-89f2-4c97-b294-15b6ebd3f80e7
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD1565528b-89f2-4c97-b294-15b6ebd3f80e7
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY1565528b-89f2-4c97-b294-15b6ebd3f80e7
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY1565528b-89f2-4c97-b294-15b6ebd3f80e7
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY1565528b-89f2-4c97-b294-15b6ebd3f80e7
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY1565528b-89f2-4c97-b294-15b6ebd3f80e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53329-083-215332900832142.5 g in 1 TUBE (53329-083-21) 42.5 g2019-08-010000-00-00NoNoCurrent
53329-083-925332900839217 g in 1 PACKET (53329-083-92) 17 g2019-08-010000-00-00NoNoCurrent
53329-083-935332900839324 g in 1 PACKET (53329-083-93) 24 g2019-08-010000-00-00NoNoCurrent
53329-083-945332900839478 g in 1 TUBE (53329-083-94) 78 g2019-08-010000-00-00NoNoCurrent