Home NDC 53329-083 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 Ingredient Strength SODIUM MONOFLUOROPHOSPHATE 1 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination C810JCZ56Q Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 545626 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53329-083-21 SparkleFreshFlouride Toothpaste 42.5 g in 1 TUBE PASTE, DENTIFRICE 42.5 7 53329-083-92 SparkleFreshFlouride Toothpaste 17 g in 1 PACKET PASTE, DENTIFRICE 17 7 53329-083-93 SparkleFreshFlouride Toothpaste 24 g in 1 PACKET PASTE, DENTIFRICE 24 7 53329-083-94 SparkleFreshFlouride Toothpaste 78 g in 1 TUBE PASTE, DENTIFRICE 78 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Sodium Monofluorophosphate ACTIVE INGREDIENT C810JCZ56Q SPARKLEFRESH FLUORIDE TOOTHPASTE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MEDLINE INDUSTRIES, INC.] 1 Fluoride Ion ACTIVE MOIETY Q80VPU408O SPARKLEFRESH FLUORIDE TOOTHPASTE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MEDLINE INDUSTRIES, INC.] 1 Calcium Carbonate INACTIVE INGREDIENT H0G9379FGK SPARKLEFRESH FLUORIDE TOOTHPASTE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MEDLINE INDUSTRIES, INC.] 1 Carboxymethylcellulose INACTIVE INGREDIENT 05JZI7B19X SPARKLEFRESH FLUORIDE TOOTHPASTE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MEDLINE INDUSTRIES, INC.] 1 Glycerin INACTIVE INGREDIENT PDC6A3C0OX SPARKLEFRESH FLUORIDE TOOTHPASTE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MEDLINE INDUSTRIES, INC.] 1 Sodium Benzoate INACTIVE INGREDIENT OJ245FE5EU SPARKLEFRESH FLUORIDE TOOTHPASTE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MEDLINE INDUSTRIES, INC.] 1 Sodium Lauryl Sulfate INACTIVE INGREDIENT 368GB5141J SPARKLEFRESH FLUORIDE TOOTHPASTE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MEDLINE INDUSTRIES, INC.] 1 Sodium Pyrophosphate INACTIVE INGREDIENT O352864B8Z SPARKLEFRESH FLUORIDE TOOTHPASTE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MEDLINE INDUSTRIES, INC.] 1 Sorbitol INACTIVE INGREDIENT 506T60A25R SPARKLEFRESH FLUORIDE TOOTHPASTE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MEDLINE INDUSTRIES, INC.] 1 Water INACTIVE INGREDIENT 059QF0KO0R SPARKLEFRESH FLUORIDE TOOTHPASTE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MEDLINE INDUSTRIES, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53329-083 SPARKLEFRESH FLOURIDE TOOTHPASTE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [MEDLINE INDUSTRIES, LP] 7 Current NDC, Legacy NDC, 4 package rows 20250108_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 33 of 50 · 995 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 53329-083-21 53329008321 42.5 g in 1 TUBE (53329-083-21) 42.5 g 2019-08-01 0000-00-00 No No Current 53329-083-92 53329008392 17 g in 1 PACKET (53329-083-92) 17 g 2019-08-01 0000-00-00 No No Current 53329-083-93 53329008393 24 g in 1 PACKET (53329-083-93) 24 g 2019-08-01 0000-00-00 No No Current 53329-083-94 53329008394 78 g in 1 TUBE (53329-083-94) 78 g 2019-08-01 0000-00-00 No No Current