FDA.reportPublic FDA data

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

Reported adverse events (FAERS/openFDA)#

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

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
C810JCZ56QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
545626Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1565528b-89f2-4c97-b294-15b6ebd3f80eAvailable on FDA.report

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

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 29 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Supersmile Professional Whitening TP Citrus BlastSODIUM MONOFLUOROPHOSPHATERobell Research, Inc25039552-c35d-a69d-e063-6394a90ab1032026-01-08WarningsExact identifier
application number: M021
Supersmile Professional Whitening TP Citrus BlastSODIUM MONOFLUOROPHOSPHATERobell Research, Inc2504686d-b053-51d0-e063-6394a90a789f2026-01-08WarningsExact identifier
application number: M021
Supersmile Professional Whitening TP Peppy Mint 8 ozSODIUM MONOFLUOROPHOSPHATERobell Research, Inc25121ebb-922b-719d-e063-6394a90a23d32026-01-08WarningsExact identifier
application number: M021
Crest Pro-health Gum Detoxify Deep CleanSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyf498b727-c38c-1d67-e053-2995a90a0f112026-01-08WarningsExact identifier
application number: M021
DG health Sensitive Maximum StrengthPOTASSIUM NITRATE, SODIUM FLUORIDEDolgencorp, LLC81cd5d37-3751-625f-e053-2a91aa0a6dfd2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Advanced Glamorous WhiteSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf5b18988-68c7-40f9-e053-2995a90a22bc2026-01-08WarningsExact identifier
application number: M021
CVS Restore and Defend Sensitive WhiteningSTANNOUS FLUORIDECVS Pharmacy81b72da2-7f41-74ca-e053-2a91aa0a96462026-01-08WarningsExact identifier
application number: M021
Gum and Enamel RepairSTANNOUS FLUORIDECVSccad05d4-7f05-bebd-e053-2a95a90aa52c2026-01-08WarningsExact identifier
application number: M021
CVS Pharmacy Pro DefenseFLUORIDECVS Pharmacy445ec57e-dc3c-49a0-8ca9-4806fcdc03032026-01-08WarningsExact identifier
application number: M021
Gum DetoxifySTANNOUS FLUORIDEWalmartad3f645d-aaf9-2800-e053-2a95a90ab62f2026-01-08WarningsExact identifier
application number: M021
CVS Complete ProtectionSTANNOUS FLOURIDECVSb681b5e4-a0e1-8d0f-e053-2a95a90aa6722026-01-06WarningsExact identifier
application number: M021
Complete ProtectionSTANNOUS FLUORIDETarget03708e08-0189-b83d-e063-6394a90a50e62026-01-06WarningsExact identifier
application number: M021
Brush Buddies Mouthwash 12oz Star Wars Saber Strike StrawberrySODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.4998c0e6-1de3-11cd-e063-6294a90acb6f2026-01-01WarningsExact identifier
application number: M021
Exceed Total Care Sensitive Spearmint Tooth PolishPOTASSIUM NITRATE AND SODIUM FLUORIDEMelaleuca, Incdc620d3f-880f-df05-e053-2995a90a84092025-12-31WarningsExact identifier
application number: M021
Exceed Total Care Sensitive Peppermint Tooth PolishPOTASSIUM NITRATE AND SODIUM FLUORIDEMelaleuca, Inced2179a4-3d19-6481-e053-2995a90ad6552025-12-31WarningsExact identifier
application number: M021
Koala Pals BerryliciousSODIUM FLUORIDEMelaleuca, Inc.6624be86-c9a8-53b8-e053-2a91aa0a87ef2025-12-31WarningsExact identifier
application number: M021
Whitening Tooth PolishSODIUM FLUORIDEMelaleuca, Inc.6893405a-a2c4-068e-e053-2a91aa0ae5b12025-12-31WarningsExact identifier
application number: M021
Gel 1100 MintSODIUM FLUORIDEDental Alliance Holdings LLCf125fb04-5045-5367-e053-2a95a90aa73b2025-12-29WarningsExact identifier
application number: M021
Gracie Square Hospital AmenitySODIUM MONOFLUOROPHOSPHATEASP Global, LLc89d81053-6950-465e-a5b1-cbf841d7afcb2025-12-29WarningsExact identifier
application number: M021
CloSYS Fluoride RinseSODIUM FLUORIDERowpar Pharmaceuticals, Inc.1a994f24-99ee-4b27-aab0-e816931a22c82025-12-23WarningsExact identifier
application number: M021

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