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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4b307471-445d-4c51-a499-d074a8172f20	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508

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
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 43 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Listerine Total Care Zero Alcohol Anticavity Fresh Mint	SODIUM FLUORIDE	Kenvue Brands LLC	4b594a6e-db1d-443b-bfa7-23ee15749f47	2024-12-19	Warnings	Exact identifier application number: M021
NewYork-Presbyterian Amenity	SODIUM MONOFLUOROPHOSPATE	ASP Global, LLc	4b307471-445d-4c51-a499-d074a8172f20	2024-12-17	Warnings	Exact identifier application number: M021 ndc (product): 59448-100
Colgate Anticavity	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive (Thailand) Limited - Branch	5bc0b430-6f68-4e52-a1da-de19136eaeac	2024-12-09	Warnings	Exact identifier application number: M021
CURODONT REPAIR FLUORIDE PLUS	SODIUM FLUORIDE	CREDENTIS AG	03ec09f9-4281-9ccb-e063-6294a90aadd8	2024-12-01	Warnings	Exact identifier application number: M021
CURODONT PROTECT	STANNOUS FLUORIDE	CREDENTIS AG	03ec591c-68c3-a380-e063-6394a90a131a	2024-12-01	Warnings	Exact identifier application number: M021
ACT Kids Anticavity Fluoride Bubble Gum Blowout	SODIUM FLUORIDE	Chattem, Inc.	61f3a3e6-645b-4368-b1d5-7de1fc14542e	2024-12-01	Warnings	Exact identifier application number: M021
SparkleFresh Flouride Toothpaste	SODIUM MONOFLUOROPHOSPHATE	Medline Industries, LP	1565528b-89f2-4c97-b294-15b6ebd3f80e	2024-11-26	Warnings	Exact identifier application number: M021
Rembrandt Intense Stain	SODIUM FLUORIDE	Ranir LLC	55dcd063-5661-35aa-e054-00144ff8d46c	2024-11-26	Warnings	Exact identifier application number: M021
Firefly Anticavity Fluoride	SODIUM FLUORIDE	Ranir LLC	9f98913f-6754-4e1c-98cf-b89fe87750f8	2024-11-25	Warnings	Exact identifier application number: M021
Colgate Total SF Clean Mint	STANNOUS FLUORIDE	Colgate-Palmolive Company	88f87f7a-5b2d-47c9-8830-6b88b4ddbb59	2024-11-25	Warnings	Exact identifier application number: M021
Firefly Bubble Gum natural fluoride	SODIUM FLUORIDE	Ranir LLC	0c85d273-3b98-43ea-81ba-c90f70ab72f8	2024-11-25	Warnings	Exact identifier application number: M021
Firefly Bubble Gum natural fluoride	SODIUM FLUORIDE	Ranir LLC	2a882210-49e6-4b9c-a2c6-eaa37b6514c3	2024-11-25	Warnings	Exact identifier application number: M021
Pepsodent Complete Care Original	SODIUM FLUORIDE	Church & Dwight Co., Inc.	3c6931cb-0ec9-41bb-b410-c355573aab57	2024-11-21	Warnings	Exact identifier application number: M021
Firefly Strawberry Natural Fluoride	SODIUM FLUORIDE	Ranir LLC	8ee37955-fe1a-4964-ac29-d1d7dfb694cc	2024-11-21	Warnings	Exact identifier application number: M021
Firefly Anticavity Fluoride	SODIUM FLUORIDE	Ranir LLC	abdc7f79-5f87-4307-8ddd-e6281ac67a04	2024-11-20	Warnings	Exact identifier application number: M021
AIM Bubble Berry	SODIUM FLUORIDE	Church & Dwight Co., Inc.	c83ccdea-d75f-4084-853e-ed4bab9a12d4	2024-11-20	Warnings	Exact identifier application number: M021
AIM TARTAR CONTROL Plus Mouthwash and Whitening	SODIUM FLUORIDE	Church & Dwight Co., Inc.	1d0fc71c-d28e-4afa-e054-00144ff8d46c	2024-11-20	Warnings	Exact identifier application number: M021
Advance White Tartar Control Breath Freshening	SODIUM FLUORIDE	Church & Dwight Co., Inc.	aa8be8f5-ba46-4b1b-afaa-58fddf8f8780	2024-11-20	Warnings	Exact identifier application number: M021
Enamel Defense	SODIUM FLUORIDE	Church & Dwight Co., Inc.	9e8f1ce9-b161-50db-e053-2995a90ad32b	2024-11-20	Warnings	Exact identifier application number: M021
Rembrandt Deeply White Plus Peroxide	SODIUM MONOFLUOROPHOSPHATE	Ranir LLC	bf7da007-ab9d-4631-bc28-6ca245fd6265	2024-11-20	Warnings	Exact identifier application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
545626	sodium monofluorophosphate 0.76 % Toothpaste	PSN	4b307471-445d-4c51-a499-d074a8172f20	10
545626	sodium monofluorophosphate 0.0076 MG/MG Toothpaste	SCD	4b307471-445d-4c51-a499-d074a8172f20	10
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste	SY	4b307471-445d-4c51-a499-d074a8172f20	10
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste	SY	4b307471-445d-4c51-a499-d074a8172f20	10
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste	SY	4b307471-445d-4c51-a499-d074a8172f20	10
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )Toothpaste	SY	4b307471-445d-4c51-a499-d074a8172f20	10

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NewYork-Presbyterian	ASP Global, LLc \| Colgate-Palmolive (Thailand) LTD \| Shengzhou Kingbird Travel Products Co., Ltd.	2024-12-17	HUMAN OTC DRUG LABEL	10