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 5 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sensitive Teeth and Gums	POTASSIUM NITRATE, SODIUM FLUORIDE	Church & Dwight Co., Inc.	935172db-d78f-0c69-e053-2a95a90a0b69	2026-07-23	Warnings	Exact identifier application number: M021
Essentials Whiten and Strengthen	SODIUM FLUORIDE 0.24%	Church & Dwight Co., Inc.	96548550-2cd1-b757-e053-2995a90a15ea	2026-07-23	Warnings	Exact identifier application number: M021
TP COL OW Purple	SODIUM FLUORIDE	Colgate-Palmolive Company	ea0db59f-f9c0-49a8-9717-69cdf071f6e1	2026-07-23	Warnings	Exact identifier application number: M021
Colgate Max Fresh Cool Mint	SODIUM FLUORIDE	Colgate-Palmolive Company	00652bb2-090c-4eaa-8fc2-e0be6913a724	2026-07-22	Warnings	Exact identifier application number: M021
Colgate Ultra White Charcoal	SODIUM FLUORIDE	Colgate-Palmolive Company	95d06fcc-f56d-43f1-924a-3f91fda59bdf	2026-07-22	Warnings	Exact identifier application number: M021
COLGATE Great Regular Flavor	SODIUM MONOFLUOROPHOSPHATE	Colgate-Palmolive Company	730f40f6-6ac6-49bd-888b-c0b5818a03c8	2026-07-20	Warnings	Exact identifier application number: M021
COLGATE KPOP DEMON HUNTERS BUBBLE POP	SODIUM FLUORIDE	Colgate-Palmolive Company	bf465181-01e9-44ca-91f8-03110a606774	2026-07-16	Warnings	Exact identifier application number: M021
Colgate Minions Mild Bubble Fruit Fluoride	SODIUM FLUORIDE	Colgate-Palmolive Company	16634b99-f305-48bf-ac54-a9f53797a9e5	2026-07-16	Warnings	Exact identifier application number: M021
Freshen Up Holiday mint	SODIUM FLUORIDE	Dabur India Limited	56aaa9f5-7eac-11d9-e063-6294a90af3a8	2026-07-15	Warnings	Exact identifier application number: M021
Freshen Up pepper mint	SODIUM FLUORIDE	Dabur India Limited	56aaba60-523e-6ac7-e063-6394a90a2756	2026-07-15	Warnings	Exact identifier application number: M021
Freshen-up Matcha Mint	SODIUM FLUORIDE	Dabur India Limited	56aac050-73e7-298c-e063-6294a90a26eb	2026-07-15	Warnings	Exact identifier application number: M021
Freshen Up twisted peppermint	SODIUM FLUORIDE	Dabur India Limited	56aac7a7-c086-2fa5-e063-6294a90aa959	2026-07-15	Warnings	Exact identifier application number: M021
Freshen Up Vanilla Mint	SODIUM FLUORIDE	Dabur India Limited	56aad223-db88-7cf6-e063-6394a90a6b72	2026-07-15	Warnings	Exact identifier application number: M021
Freshen Up	SODIUM FLUORIDE	MKJ BRANDS LLC	2dcd4816-caa5-c006-e063-6394a90ac487	2026-07-15	Warnings	Exact identifier application number: M021
Freshen Up	SODIUM FLUORIDE	DABUR INDIA LIMITED	56acecd2-6966-2ee4-e063-6394a90a356f	2026-07-15	Warnings	Exact identifier application number: M021
Colgate Max Fresh Advanced Whitening	SODIUM FLUORIDE	Colgate-Palmolive Company	01c07c25-2748-4d90-9505-094e2c977c9c	2026-07-15	Warnings	Exact identifier application number: M021
Crest Strawberry	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	7d51c67b-7409-e5a7-e053-2a91aa0a81fa	2026-07-14	Warnings	Exact identifier application number: M021
Freshen Up	SODIUM FLUORIDE, POTASSIUM NITRATE	MKJ BRANDS LLC	476f453b-9215-0a11-e063-6294a90a5cd4	2026-07-14	Warnings	Exact identifier application number: M021
Freshen Up Vanilla Mint	SODIUM FLUORIDE	MKJ BRANDS LLC	525662da-42be-eaa6-e063-6294a90af110	2026-07-14	Warnings	Exact identifier application number: M021
Freshen Up twisted peppermint	SODIUM FLUORIDE	MKJ BRANDS LLC	526acbdd-6531-692d-e063-6394a90ab9f1	2026-07-14	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