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 46 of 50 · 995 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Brush Buddies Barbie ANTICAVITY FLUORIDE - Bubble Gum Flavor SODIUM FLUORIDE Ashtel Studios Inc. bbf6cfe7-c5e5-4e63-ac7d-4535a0ca3973 2024-07-31 Warnings Exact identifier application number: M021 Brush Buddies Crayola ANTICAVITY FLUORIDE - WATERMELON FLAVOR SODIUM FLUORIDE Ashtel Studios Inc. 32780fe9-82bf-42f8-8218-bed5bc579c72 2024-07-30 Warnings Exact identifier application number: M021 Brush Buddies Hot Wheels ANTICAVITY FLUORIDE - STRAWBERRY FLAVOR SODIUM FLUORIDE Ashtel Studios Inc. 7ba8cff2-92a4-4432-aaf3-50358d9483a2 2024-07-30 Warnings Exact identifier application number: M021 Brush Buddies Crayola ANTICAVITY FLUORIDE - BUBBLE GUM FLAVOR SODIUM FLUORIDE Ashtel Studios Inc. ed057c95-90cd-4edb-ac00-78db8f6a065b 2024-07-29 Warnings Exact identifier application number: M021 Brush Buddies Crayola ANTICAVITY FLUORIDE - STRAWBERRY FLAVOR SODIUM FLUORIDE Ashtel Studios Inc. f01c5eaf-7e81-4b30-bb6f-50566a727364 2024-07-29 Warnings Exact identifier application number: M021 Sodium Monofluorophosphate WHITE TOOTHPASTE Dynarex Corporation 1be422b9-6320-ed5c-e063-6294a90a7e42 2024-07-03 Warnings Exact identifier application number: M021 Wpgcng Antiacvity Fluoride Mouthwash SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD. 5756206e-43cc-8cc7-e063-6394a90a2950 2024-07-03 Warnings Exact identifier application number: M021 dentalux Kids ANTI-CAVITY FLUORIDE Bubble Gum SODIUM FLUORIDE Lidl US, LLC 0c77ba33-acb9-4c83-aa75-7d5c82f903eb 2024-07-02 Warnings Exact identifier application number: M021 dentalux ANTI-CAVITY FLUORIDE WHITENING MINT SODIUM FLUORIDE Lidl US, LLC 37011052-16ef-4ae4-aade-a86f9fa9cdac 2024-07-02 Warnings Exact identifier application number: M021 dentalux ANTI-CAVITY FLUORIDE SODIUM MONOFLUOROPHOSPHATE Lidl US, LLC ccf54743-81c2-43f8-9c5c-d4baa85fc18d 2024-07-02 Warnings Exact identifier application number: M021 SmileSense STANNOUS FLUORIDE SGII, INC 1c371393-da75-c9c8-e063-6294a90a5840 2024-07-01 Warnings Exact identifier application number: M021 Sodium Fluoride CLEAR MINT, GEL TOOTHPASTE Dynarex Corporation 1be193b6-4c07-4f0a-e063-6394a90a32c7 2024-06-27 Warnings Exact identifier application number: M021 CREST CAVITY PROTECTION COOL MINT SODIUM FLUORIDE A-S Medication Solutions dba7a572-a2f0-4c95-b2a7-cf7301e8ca9d 2024-06-12 Warnings Exact identifier application number: M021 Brush Buddies Crayola ANTICAVITY FLUORIDE - BUBBLE GUM FLAVOR SODIUM FLUORIDE Ashtel Studios Inc. a37e9d9c-dca9-4d58-a716-4514ebe8ec88 2024-06-11 Warnings Exact identifier application number: M021 Brush Buddies Crayola ANTICAVITY FLUORIDE - STRAWBERRY FLAVOR SODIUM FLUORIDE Ashtel Studios Inc. 0e6b01a4-1132-489f-936c-d3a54e9e21e0 2024-06-11 Warnings Exact identifier application number: M021 Brush Buddies Crayola ANTICAVITY FLUORIDE - WATERMELON FLAVOR SODIUM FLUORIDE Ashtel Studios Inc. ffb8c43c-8f45-42ec-83eb-f0c83f7f99f8 2024-06-11 Warnings Exact identifier application number: M021 HIMALAYA PINK SALT Purple Color Corrector plus Intensive Whitening Toothpaste SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. 1a26ad70-9773-dc4f-e063-6294a90ac333 2024-05-31 Warnings Exact identifier application number: M021 HIMALAYA PINK SALT Purple Color Corrector plus Intensive Whitening Toothpaste SODIUM FLUORIDE LG H&H Co.,Ltd. 1a01481f-3e02-634e-e063-6394a90ac5fc 2024-05-31 Warnings Exact identifier application number: M021 Brush Buddies - Hot Wheels ANTICAVITY FLUORIDE SODIUM FLUORIDE Ashtel Studios Inc. 86dd5e9c-71c3-46ce-ae4c-45d19468667d 2024-05-29 Warnings Exact identifier application number: M021 Dentalclean Doctor Duck Kids Flouride Mouthwash SODIUM FLUORIDE 0.02% Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda 18806738-82fa-1a37-e063-6294a90a3888 2024-05-15 Warnings Exact identifier application number: M021
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