Home NDC 59448-100 NewYork-Presbyterian Amenity
Product NDC 59448-100
11-digit product format 594480100
Labeler code 59448
Product ID 59448-100_09361814-62c1-4490-bba1-9e140746d747
Type HUMAN OTC DRUG
Nonproprietary name Sodium Monofluorophospate
Dosage form KIT
Labeler ASP Global, LLc
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2013-07-01
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 NewYork-Presbyterian Amenity
Listing expiration 2026-12-31 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 59448-100-00 NewYork-Presbyterian Amenity 1 in 1 BAG KIT 1 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Sodium Monofluorophosphate ACTIVE INGREDIENT C810JCZ56Q NEWYORK-PRESBYTERIAN AMENITY (SODIUM MONOFLUOROPHOSPATE) KIT [ANATOMY SUPPLY PARTNERS, LLC] 4 Fluoride Ion ACTIVE MOIETY Q80VPU408O NEWYORK-PRESBYTERIAN AMENITY (SODIUM MONOFLUOROPHOSPATE) KIT [ANATOMY SUPPLY PARTNERS, LLC] 4 Calcium Phosphate, Dibasic, Dihydrate INACTIVE INGREDIENT O7TSZ97GEP NEWYORK-PRESBYTERIAN AMENITY (SODIUM MONOFLUOROPHOSPATE) KIT [ANATOMY SUPPLY PARTNERS, LLC] 4 Saccharin Sodium INACTIVE INGREDIENT SB8ZUX40TY NEWYORK-PRESBYTERIAN AMENITY (SODIUM MONOFLUOROPHOSPATE) KIT [ANATOMY SUPPLY PARTNERS, LLC] 4 Sodium Lauryl Sulfate INACTIVE INGREDIENT 368GB5141J NEWYORK-PRESBYTERIAN AMENITY (SODIUM MONOFLUOROPHOSPATE) KIT [ANATOMY SUPPLY PARTNERS, LLC] 4 Sodium Pyrophosphate INACTIVE INGREDIENT O352864B8Z NEWYORK-PRESBYTERIAN AMENITY (SODIUM MONOFLUOROPHOSPATE) KIT [ANATOMY SUPPLY PARTNERS, LLC] 4 Sorbitol INACTIVE INGREDIENT 506T60A25R NEWYORK-PRESBYTERIAN AMENITY (SODIUM MONOFLUOROPHOSPATE) KIT [ANATOMY SUPPLY PARTNERS, LLC] 4 Water INACTIVE INGREDIENT 059QF0KO0R NEWYORK-PRESBYTERIAN AMENITY (SODIUM MONOFLUOROPHOSPATE) KIT [ANATOMY SUPPLY PARTNERS, LLC] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59448-100 NEWYORK-PRESBYTERIAN AMENITY (SODIUM MONOFLUOROPHOSPATE) KIT [ASP GLOBAL, LLC] 10 Current NDC, Legacy NDC, 1 package rows 20241222_4b307471-445d-4c51-a499-d074a8172f20.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 37 of 50 · 995 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Cloveden 100 times higher concentrated CETYLPYRIDINIUM CHLORIDE Acuseplanet Inc 3c0e1862-293f-4d23-e063-6294a90a33e1 2025-08-10 Warnings Exact identifier application number: M021 Ipana Wintergreen Fluoride SODIUM MONOFLUOROPHOSPHATE Maxill Inc. 5776cc3e-4fd1-4bd7-8d82-f82508e6b8d0 2025-07-28 Warnings Exact identifier application number: M021 Ipana Bucky Beaver Bubble Gum Childrens Fluoride SODIUM MONOFLUOROPHOSPHATE Maxill Inc e7aa2a8d-7140-4718-bf69-917bb50d32c7 2025-07-28 Warnings Exact identifier application number: M021 Dubai Chocolate Flavor ANTICAVITY TOOTHPASTE SuperMouth, LLC. d1615a53-ecfc-49d1-b836-f7643b9d2660 2025-07-24 Warnings Exact identifier application number: M021 ACT Restoring Anticavity Fluoride Mint Burst SODIUM FLUORIDE Chattem, Inc. 0c7ede82-3b28-40ae-8dfd-cec58825f938 2025-07-23 Warnings Exact identifier application number: M021 Dubai Chocolate Fluoride Mouthwash ANTICAVITY MOUTHWASH SuperMouth, LLC. ef81a983-64c1-4913-9235-25451f023852 2025-07-23 Warnings Exact identifier application number: M021 ACT Restoring Anticavity Fluoride Cool Mint SODIUM FLUORIDE Chattem, Inc. 3409a749-4a1a-4950-8c21-364d1b977af7 2025-07-22 Warnings Exact identifier application number: M021 Act Total Care Anticavity Fluoride Fresh Mint SODIUM FLUORIDE Chattem, Inc. dc209500-2bf4-42fb-b3a1-d0fb8d63dbd8 2025-07-22 Warnings Exact identifier application number: M021 Brush Buddies Oral Rinse Sparkle Mint SODIUM FLUORIDE ASHTEL STUDIOS, INC fe2c06fc-6497-4888-877f-1a88e02fad20 2025-07-15 Warnings Exact identifier application number: M021 evo SENSITIVE WHITENING ANTI-CAVITY FLUORIDE SODIUM FLUORIDE Ashtel Studios, Inc. 1620c7fa-2af6-4462-af5d-9e122942788a 2025-07-15 Warnings Exact identifier application number: M021 Dentalclean Green Diamond Alcohol Free Mouthwash SODIUM FLUORIDE 0.05% Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda 5653aa33-4f0e-46b2-9be0-6219143556ec 2025-07-14 Warnings Exact identifier application number: M021 Colgate Total Gum Protect Fresh Mint STANNOUS FLUORIDE COLGATE PALMOLIVE COMPANY 570e3bd6-eede-4270-9d78-055aeb2b8c17 2025-07-14 Warnings Exact identifier application number: M021 OraPro Fluoride Anticavity FLUORIDE TOOTHPASTE Protegera, Inc. 93b0181c-e29f-42f4-80f5-366463b68f09 2025-07-10 Warnings Exact identifier application number: M021 Enamur Fluoride AntiCavity Toothpast FLUORIDE TOOTHPAST Protegera, Inc 557ced45-f54e-43d8-aa13-46f75b79367c 2025-07-10 Warnings Exact identifier application number: M021 Super Strawberry STRAWBERRY TOOTHPASTE SuperMouth, LLC. a8c2b68d-d28b-41c0-a383-cc706b25aa1a 2025-07-05 Warnings Exact identifier application number: M021 Super Mint SUPER MINT TOOTHPASTE SuperMouth, LLC. be0915f3-36c4-4200-9d15-704cfbd632b4 2025-07-05 Warnings Exact identifier application number: M021 Super Vanilla VANILLA TOOTHPASTE SuperMouth, LLC. 3ddfe20a-86f1-4566-bb77-82c9749411f6 2025-07-05 Warnings Exact identifier application number: M021 Super Chocolate CHOCOLATE TOOTHPASTE SuperMouth, LLC. 48607622-7c5e-4ddc-8d83-707f26c0553f 2025-07-05 Warnings Exact identifier application number: M021 Brush Buddies ADVANCED WHITENING ANTI-CAVITY FLUORIDE PEPPERMINT SODIUM FLUORIDE Ashtel Studios, Inc. 13dba3ce-88a8-490c-a906-cfd206d1d290 2025-07-01 Warnings Exact identifier application number: M021 evo ADVANCED WHITENING ANTI-CAVITY FLUORIDE PEPPERMINT SODIUM FLUORIDE Ashtel Studios, Inc. baae4f4a-54ef-472a-9c94-31703435750b 2025-07-01 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 59448-100-00 59448010000 1 KIT in 1 BAG (59448-100-00) * 60 mL in 1 TUBE * 65 mL in 1 BOTTLE, PLASTIC * 4.25 g in 1 TUBE * 10 g in 1 TUBE (42555-060-45) * 60 mL in 1 TUBE * 60 mL in 1 TUBE * 28 g in 1 CELLO PACK 1 kit 2013-07-01 0000-00-00 No No Current