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 44 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Colgate Kids Space Jam Mild Bubble Fruit Flavor	SODIUM FLUORIDE	Colgate-Palmolive Company	54cbfb09-8fd7-ef08-99fd-14fc019c81ff	2024-11-14	Warnings	Exact identifier application number: M021
Colgate Kids Llama Mild Bubble Fruit Flavor	SODIUM FLUORIDE	Colgate-Palmolive	a7b02cb2-cfb3-7b35-42da-7924d156dcc3	2024-11-14	Warnings	Exact identifier application number: M021
Colgate MaxFresh with Mini Breath Clean Mint	SODIUM FLUORIDE	Colgate-Palmolive Company	82bc1101-84d7-4e21-be9c-870ad88a4b7c	2024-11-14	Warnings	Exact identifier application number: M021
Colgate MaxFresh Knockout	SODIUM FLUORIDE	COLGATE PALMOLIVE COMPANY	b6ca4ec7-5087-4693-82b7-199b44d7f931	2024-11-13	Warnings	Exact identifier application number: M021
Listerine Smart Rinse Berry Splash	SODIUM FLUORIDE	Kenvue Brands LLC	5c9d763b-7fa2-4b6f-9247-fd28eeda7f0b	2024-11-11	Warnings	Exact identifier application number: M021
Listerine Clinical Solutions Teeth Strength Alpine Mint	SODIUM FLUORIDE	Kenvue Brands LLC	06e2de03-4a58-3de0-e063-6294a90a5857	2024-11-11	Warnings	Exact identifier application number: M021
Listerine Smart Rinse Anticavity Fluoride Rinse - Berry Splash	SODIUM FLUORIDE	Kenvue Brands LLC	ee9a962d-83c7-4b13-bff6-140e48785e8a	2024-11-11	Warnings	Exact identifier application number: M021
Listerine Smart Rinse Anticavity Fluoride Rinse - Mint Shield	SODIUM FLUORIDE	Kenvue Brands LLC	d69d2e0d-a3e3-4d95-992d-c0c59172b3a5	2024-11-11	Warnings	Exact identifier application number: M021
Listerine Smart Rinse Anticavity Fluoride Rinse - Bubble Blast	SODIUM FLUORIDE	Kenvue Brands LLC	f09f334b-709c-473e-b91e-3f31480ceb90	2024-11-11	Warnings	Exact identifier application number: M021
HIMALAYA PINK SALT Purple Color Corrector plus Intensive Whitening Vanilla Mint	SODIUM FLUORIDE	LG H&H Co.,Ltd.	2697fa68-b991-ab09-e063-6394a90aec4c	2024-11-01	Warnings	Exact identifier application number: M021
HIMALAYA PINK SALT Purple Color Corrector plus Intensive Whitening Vanilla Mint	SODIUM FLUORIDE	Tai Guk Pharma. Co., Ltd.	2698d6d8-051b-6c10-e063-6394a90a9418	2024-11-01	Warnings	Exact identifier application number: M021
Made by Dentist for Kids Chew Toy (Bubblegum)	SODIUM FLUORIDE	MADE BY DENTISTS INC	263c448b-728f-4370-bcdb-148d614d9b34	2024-10-30	Warnings	Exact identifier application number: M021
OCEAN FRIENDS ANTICAVITY FLUORIDE BUBBLEGUM FLAVOR	SODIUM FLUORIDE	CVS Pharmacy, Inc.	17f589e9-f4ba-46d3-a345-db38f9a9067d	2024-10-17	Warnings	Exact identifier application number: M021
ACT Kids Anticavity Fluoride Wild Watermelon	SODIUM FLUORIDE	Chattem, Inc.	8d7faeab-ac70-472a-acbb-de67493718ce	2024-10-16	Warnings	Exact identifier application number: M021
Rexall Restore and Defend Sensitive Whitening	STANNOUS FLUORIDE	Old East Main CO.	691c9638-75d2-4e53-bec4-2eafacd7216c	2024-10-14	Warnings	Exact identifier application number: M021
Rexall Travel Toothbrush and Tooth-paste	SODIUM MONOFLUOROPHOSPHATE	Old East Main CO.	1bfba18b-1418-4c39-b666-96fa0674cc70	2024-10-14	Warnings	Exact identifier application number: M021
Crest Cavity Protection Regular	SODIUM FLUORIDE	Navajo Manufacturing Company Inc.	23851360-e30e-dd97-e063-6394a90a5474	2024-10-02	Warnings	Exact identifier application number: M021
Colgate Total SF Clean Mint	STANNOUS FLUORIDE	Colgate-Palmolive Company	8e79e33c-88d3-afc2-e5a2-c6ad55db0dc0	2024-10-02	Warnings	Exact identifier application number: M021
Colgate Total SF Whitening Charcoal	STANNOUS FLUORIDE	Colgate-Palmolive Company	36cd9cfc-7390-4400-8ede-b9d172d83953	2024-10-02	Warnings	Exact identifier application number: M021
Colgate Total SF Deep Clean	STANNOUS FLUORIDE	Colgate-Palmolive Company	85e83b72-2d09-aec0-db7e-6b5715c5a86c	2024-10-01	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