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 20 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Colgate Cavity Protection Great Regular Flavor	ANTICAVITY FLUORIDE TOOTHPASTE	Colgate-Palmolive Company	202c6c62-e16a-4716-babe-d5414006c79e	2026-01-21	Warnings	Exact identifier application number: M021
Crest 3D White Luxe Diamond Strong	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	c1420129-5460-4900-ac9a-356d2d7c60a2	2026-01-21	Warnings	Exact identifier application number: M021
Crest Pro-Health Advanced Max Cavity and Erosion Prevention	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	48eb0bdc-7399-745d-e063-6294a90a9809	2026-01-21	Warnings	Exact identifier application number: M021
Colgate Total Gum Protect Whitening	STANNOUS FLUORIDE	Colgate-Palmolive Company	dcf81dcb-b26b-4411-82d4-5f7e9d3fc0f3	2026-01-20	Warnings	Exact identifier application number: M021
GuruNanda Anti-Cavity	SODIUM FLUORIDE	GURUNANDA, LLC	3b07b72f-4efc-eb0f-e063-6294a90a70a8	2026-01-19	Warnings	Exact identifier application number: M021
GuruNanda Anticavity	SODIUM FLUORIDE	GURUNANDA, LLC	3e90d516-3172-3c8d-e063-6294a90a394f	2026-01-19	Warnings	Exact identifier application number: M021
Hismile	PEACH ICED TEA FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE	Hismile Pty Ltd	0eba92d1-cbdc-9c96-e063-6294a90a9afc	2026-01-15	Warnings	Exact identifier application number: M021
Hismile	COCONUT WHIP FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE	Hismile Pty Ltd	0ef3cfb6-6bae-1682-e063-6394a90aca88	2026-01-15	Warnings	Exact identifier application number: M021
Hismile	MANGO SORBET FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE	Hismile Pty Ltd	0ef3f4f8-fdc4-2056-e063-6394a90a6fd7	2026-01-15	Warnings	Exact identifier application number: M021
Hismile	SMOOTH MINT FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE	Hismile Pty Ltd	0ef41051-dfa0-b105-e063-6294a90a551f	2026-01-15	Warnings	Exact identifier application number: M021
Hismile	WATERMELON FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE	Hismile Pty Ltd	0ef43107-58ec-d4ee-e063-6294a90ad8d7	2026-01-15	Warnings	Exact identifier application number: M021
Hismile	RED VELVET FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE	Hismile Pty Ltd	0ef56539-dc21-c6ea-e063-6394a90a5790	2026-01-15	Warnings	Exact identifier application number: M021
Hismile	GRAPE BUBBLEGUM FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE	Hismile Pty Ltd	0ef6f8b5-8565-b364-e063-6294a90aabbc	2026-01-15	Warnings	Exact identifier application number: M021
Hismile	STRAWBERRY FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE	Hismile Pty Ltd	0ef766ae-754a-f185-e063-6294a90a3299	2026-01-15	Warnings	Exact identifier application number: M021
Hismile	BANANA FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE	Hismile Pty Ltd	0ef7be5b-df8f-9f32-e063-6394a90a4724	2026-01-15	Warnings	Exact identifier application number: M021
Hismile	VANILLA FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE	Hismile Pty Ltd	0ef8d0ef-a051-f610-e063-6394a90a8537	2026-01-15	Warnings	Exact identifier application number: M021
HISMILE	SODIUM FLUORIDE	HISMILE PTY LTD	1d40b98b-2e9a-d84a-e063-6294a90a2096	2026-01-15	Warnings	Exact identifier application number: M021
HISMILE	SODIUM FLUORIDE	HISMILE PTY LTD	1d44863e-93be-2b80-e063-6294a90a4a9d	2026-01-15	Warnings	Exact identifier application number: M021
HISMILE	SODIUM FLUORIDE	HISMILE PTY LTD	1d458ccc-8f1e-f9c8-e063-6294a90a8da4	2026-01-15	Warnings	Exact identifier application number: M021
HISMILE	SODIUM FLUORIDE	HISMILE PTY LTD	1d447939-fbf6-42f6-e063-6294a90af6d9	2026-01-15	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