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 45 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Colgate Total SF Advanced Whitening	STANNOUS FLUORIDE	Colgate-Palmolive Company	cef9a30c-a18c-47e9-b276-f56608f0400f	2024-10-01	Warnings	Exact identifier application number: M021
Colgate Total SF Whitening	STANNOUS FLUORIDE	Colgate-Palmolive Company	86c4b51e-b086-4566-8f94-a951bf0c6254	2024-09-30	Warnings	Exact identifier application number: M021
Colgate Total Whitening Fresh Boost	STANNOUS FLUORIDE	Colgate-Palmolive Company	c436382e-2755-c882-2970-4be1b9ca537b	2024-09-30	Warnings	Exact identifier application number: M021
Colgate Total SF Whitening Gel	STANNOUS FLUORIDE	Colgate-Palmolive Company	27c4eed5-9121-4e09-9d42-e0a3e8430109	2024-09-30	Warnings	Exact identifier application number: M021
Colgate Total Whitening Charcoal	STANNOUS FLUORIDE	Colgate-Palmolive Company	56434e3d-ba0a-8b42-6c97-0d0055606793	2024-09-30	Warnings	Exact identifier application number: M021
Colgate Total SF Mint Stripe Gel	STANNOUS FLUORIDE	Colgate-Palmolive Company	abfbcacd-9c1a-4472-9e91-a85e78050a9e	2024-09-30	Warnings	Exact identifier application number: M021
Colgate Total SF Advanced Whitening	STANNOUS FLUORIDE	Colgate-Palmolive Company	f8aeac8e-6a3e-4ada-bb13-db337b934ba3	2024-09-27	Warnings	Exact identifier application number: M021
OCEAN FRIENDS ANTICAVITY FLUORIDE WATERMELON FLAVOR	SODIUM FLUORIDE	CVS Pharmacy, Inc.	4a68bd30-91d3-46c9-a3d4-4fe342b5e6ef	2024-09-27	Warnings	Exact identifier application number: M021
Colgate Total SF Advanced Deep Clean	STANNOUS FLUORIDE	Colgate-Palmolive Company	92642408-4465-4f8f-85f9-cf12aadc147b	2024-09-27	Warnings	Exact identifier application number: M021
Brush Buddies SQUISHMALLOWS ANTICAVITY FLUORIDE MINT FLAVOR	SODIUM FLUORIDE	Ashtel Studios Inc.	b197ac2d-f9d6-4937-a0a6-2f425e4c3796	2024-09-26	Warnings	Exact identifier application number: M021
Brush Buddies SQUISHMALLOWS ANTICAVITY FLUORIDE MINT FLAVOR	SODIUM FLUORIDE	Ashtel Studios, Inc	dc04ee5c-3561-4579-8f9b-00266a8c8871	2024-09-25	Warnings	Exact identifier application number: M021
Made by Dentists For Kids Cheetah Dust (Strawberry)	SODIUM FLUORIDE	MADE BY DENTISTS INC	94939abe-b05e-4ea2-a1a6-204da857b4aa	2024-09-18	Warnings	Exact identifier application number: M021
ACT Anticavity Fluoride Arctic Blast	SODIUM FLUORIDE	Chattem, Inc.	2d5c1ce7-3c3e-415e-9469-a8d3ddfe2c57	2024-08-22	Warnings	Exact identifier application number: M021
CinnaFresh	SODIUM FLUORIDE	Bob Barker Company Inc.	3fbd95f0-a10c-4351-ad80-7e90b2d6a6f5	2024-08-22	Warnings	Exact identifier application number: M021
Karl and Hans Botanic Double Mint	SODIUM MONOFLUOROPHOSPHATE	PIGEON CORPORATION	d1233fc3-047c-4e26-bb2b-8ebde09c05a9	2024-08-08	Warnings	Exact identifier application number: M021
Karl and Hans Botanic Jasmine	SODIUM MONOFLUOROPHOSPHATE	PIGEON CORPORATION	6c0335e6-f041-48c7-9da3-88c124b84b00	2024-08-08	Warnings	Exact identifier application number: M021
OMNI	STANNOUS FLUORIDE	Solventum US LLC	0c2a81b1-65b5-432b-8e66-30432a245aba	2024-08-01	Warnings	Exact identifier application number: M021
Just For Kids	STANNOUS FLUORIDE	Solventum US LLC	0f1afc36-f699-4072-b90b-c9f5be989a49	2024-08-01	Warnings	Exact identifier application number: M021
Clinpro Tooth Creme	SODIUM FLUORIDE	Solventum US LLC	786c6184-6bc8-4376-9ce2-3e35af193210	2024-08-01	Warnings	Exact identifier application number: M021
PerioMed	STANNOUS FLUORIDE	Solventum US LLC	7f79eb00-86df-4284-b415-47f45e4849da	2024-08-01	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