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 30 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MIPasteOne Kids Blue Raspberry	MI PASTE ONE KIDS BLUE RASPBERRY	GC America Inc.	bf7d668c-752a-2eee-e053-2a95a90add16	2025-12-19	Warnings	Exact identifier application number: M021
MIPaste Plus Tutti Frutti	MIPASTE PLUS TUTTI FRUTTI	GC America Inc.	d724bd2a-2a8e-faeb-e053-2995a90aca19	2025-12-19	Warnings	Exact identifier application number: M021
MIPaste Plus Vanilla	MIPASTE PLUS VANILLA	GC America Inc.	d7244125-1ca5-78ba-e053-2995a90ab764	2025-12-19	Warnings	Exact identifier application number: M021
MIPaste Plus Melon	MIPASTE PLUS MELON	GC America Inc.	d724fe9f-c9ef-d9ad-e053-2995a90a7ecf	2025-12-19	Warnings	Exact identifier application number: M021
MIPaste Plus Mint	MIPASTE PLUS MINT	GC America Inc.	d72415b3-c501-141f-e053-2995a90aaaa3	2025-12-19	Warnings	Exact identifier application number: M021
MIPaste One Perio	MIPASTE ONE PERIO	GC America Inc.	d656b72d-48f8-4425-e053-2995a90ab1f2	2025-12-19	Warnings	Exact identifier application number: M021
MIPaste One Kids Blue Raspberry	MIPASTE ONE KIDS BLUE RASPBERRY	GC America Inc.	c07e1058-903b-fd47-e053-2995a90afdab	2025-12-19	Warnings	Exact identifier application number: M021
MIPaste Plus Strawberry	MIPASTE PLUS STRAWBERRY	GC America Inc.	d7235ad7-83d7-12e5-e053-2a95a90aaeaf	2025-12-19	Warnings	Exact identifier application number: M021
MIPaste One Kids Cotton Candy	MIPASTE ONE KIDS COTTON CANDY	GC America Inc.	c07d6b50-1d67-ea7f-e053-2a95a90afbe4	2025-12-19	Warnings	Exact identifier application number: M021
MIPaste One Kids Bubble Gum	MIPASTE ONE KIDS BUBBLE GUM	GC America Inc.	c07c7853-763b-4383-e053-2995a90ab725	2025-12-19	Warnings	Exact identifier application number: M021
MIPaste One	MIPASTE ONE	GC America Inc.	d71f8e6e-7005-4b3e-e053-2995a90a6789	2025-12-19	Warnings	Exact identifier application number: M021
TheraBreath AM-PM Twin Pack	SODIUM FLUORIDE	Church & Dwight Co., Inc.	4618e390-9039-a1d0-e063-6294a90ab294	2025-12-16	Warnings	Exact identifier application number: M021
Parodontax Gum Strengthen and Protect	STANNOUS FLUORIDE	Haleon US Holdings LLC	3bb40ceb-841b-4a25-e063-6294a90ab897	2025-12-15	Warnings	Exact identifier application number: M021
Sensodyne Pronamel Kids Bubble Mint	SODIUM FLUORIDE	Haleon US Holdings LLC	41b1e626-e79b-d638-e063-6394a90a1f5b	2025-12-15	Warnings	Exact identifier application number: M021
Simple Truth Kids Flouride	SODIUM MONOFLUOROPHOSPHATE	Kroger Company	82b9db89-d108-3f64-e053-2991aa0aee74	2025-12-15	Warnings	Exact identifier application number: M021
Natural Adult Fluoride	SODIUM MONOFLUOROPHOSPHATE	Kroger	a71c537e-39d9-1c3b-e053-2a95a90ac3ec	2025-12-15	Warnings	Exact identifier application number: M021
Therabreath Overnight Chamomile Mint	SODIUM FLUORIDE	Church & Dwight Co., Inc.	cc0c533c-145e-4877-b421-1baf3a3a572e	2025-12-11	Warnings	Exact identifier application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE BUBBLEGUM	SODIUM FLUORIDE	Kingkey MBC Life Technology Group co., LTD.	188d28f9-a814-0f98-e063-6294a90a106b	2025-12-11	Warnings	Exact identifier application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE WATERMELON	SODIUM FLUORIDE	Kingkey MBC Life Technology Group Co.,Ltd	1b4cf935-38a6-f4fb-e063-6394a90a4bc0	2025-12-11		Exact identifier application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE WATERMELON	SODIUM FLUORIDE	Kingkey MBC Life Technology Group co., LTD.	188cddb2-c799-0897-e063-6294a90a5d96	2025-12-11	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