FDA.reportPublic FDA data

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
IdentifierFDA.report destination
545626Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4b307471-445d-4c51-a499-d074a8172f20Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59448-100-00NewYork-Presbyterian Amenity1 in 1 BAGKIT110

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Sodium MonofluorophosphateACTIVE INGREDIENTC810JCZ56QNEWYORK-PRESBYTERIAN AMENITY (SODIUM MONOFLUOROPHOSPATE) KIT [ANATOMY SUPPLY PARTNERS, LLC]4
Fluoride IonACTIVE MOIETYQ80VPU408ONEWYORK-PRESBYTERIAN AMENITY (SODIUM MONOFLUOROPHOSPATE) KIT [ANATOMY SUPPLY PARTNERS, LLC]4
Calcium Phosphate, Dibasic, DihydrateINACTIVE INGREDIENTO7TSZ97GEPNEWYORK-PRESBYTERIAN AMENITY (SODIUM MONOFLUOROPHOSPATE) KIT [ANATOMY SUPPLY PARTNERS, LLC]4
Saccharin SodiumINACTIVE INGREDIENTSB8ZUX40TYNEWYORK-PRESBYTERIAN AMENITY (SODIUM MONOFLUOROPHOSPATE) KIT [ANATOMY SUPPLY PARTNERS, LLC]4
Sodium Lauryl SulfateINACTIVE INGREDIENT368GB5141JNEWYORK-PRESBYTERIAN AMENITY (SODIUM MONOFLUOROPHOSPATE) KIT [ANATOMY SUPPLY PARTNERS, LLC]4
Sodium PyrophosphateINACTIVE INGREDIENTO352864B8ZNEWYORK-PRESBYTERIAN AMENITY (SODIUM MONOFLUOROPHOSPATE) KIT [ANATOMY SUPPLY PARTNERS, LLC]4
SorbitolINACTIVE INGREDIENT506T60A25RNEWYORK-PRESBYTERIAN AMENITY (SODIUM MONOFLUOROPHOSPATE) KIT [ANATOMY SUPPLY PARTNERS, LLC]4
WaterINACTIVE INGREDIENT059QF0KO0RNEWYORK-PRESBYTERIAN AMENITY (SODIUM MONOFLUOROPHOSPATE) KIT [ANATOMY SUPPLY PARTNERS, LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59448-100NEWYORK-PRESBYTERIAN AMENITY (SODIUM MONOFLUOROPHOSPATE) KIT [ASP GLOBAL, LLC]10Current NDC, Legacy NDC, 1 package rows20241222_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 47 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dentalclean Blue Diamond Alcohol Free MouthwashSODIUM FLUORIDE 0.05%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda1881658c-e371-5513-e063-6394a90a465f2024-05-15WarningsExact identifier
application number: M021
Dentalclean Dr. Duck Strawberry flouride MouthwashSODIUM FLUORIDE 0.02%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda1882c82a-3a32-5656-e063-6394a90ae0ed2024-05-15WarningsExact identifier
application number: M021
Dentalclean Booster KidsSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda186ecaeb-9401-9315-e063-6394a90a8e202024-05-14WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA ATTITUDEfefc1060-e1a4-4686-a8d8-84bf1e613abe2024-05-14WarningsExact identifier
application number: M021
Dentalclean Doctor DuckSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda186f2f12-279f-32df-e063-6394a90ad53d2024-05-14WarningsExact identifier
application number: M021
Barbie Bubble Gum ANTICAVITY FLUORIDESODIUM FLUORIDEAshtel Studios Inc.dc5489e9-eeff-4db5-8793-21fb5bf4b2ef2024-05-10WarningsExact identifier
application number: M021
Dentalclean Regenerator Sensitive KidsSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda17f31b5e-dd3b-78df-e063-6294a90a43ab2024-05-08WarningsExact identifier
application number: M021
Dentalclean Dental Gel Booster Adult UseSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda17f3981f-ab4b-0dcd-e063-6294a90a37d92024-05-08WarningsExact identifier
application number: M021
Dentalclean Sensitive PlusSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda17e0dc93-97bf-7f05-e063-6294a90a9a8b2024-05-07WarningsExact identifier
application number: M021
Dentalclean Whitening MaxSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda17e2364e-2511-3021-e063-6294a90a40e12024-05-07WarningsExact identifier
application number: M021
DeCureSODIUM MONOFLUOROPHOSPHATEScope medical devices private limited590c4827-f036-45bd-af30-0a4853ca34472024-05-07WarningsExact identifier
application number: M021
Gelato HomecareSTANNOUS FLUORIDEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.07d7fb43-8d3e-4d1f-b38d-e3caf28e9acf2024-04-22WarningsExact identifier
application number: M021
Gelato HomecareSTANNOUS FLUORIDEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.1e93d4f8-1eec-40f8-8a6d-86e96dfeb8db2024-04-19WarningsExact identifier
application number: M021
Toothpaste, plus ToothbrushSODIUM FLUORIDE PASTE, DENTIFRICE AND TOOTHBRUSHLil' Drug Store Products, Inc.15ac00f8-da51-6cea-e063-6294a90aeb812024-04-09WarningsExact identifier
application number: M021
HIMALAYA PINK SALT Intensive Whitening SpearmintSODIUM FLUORIDELG H&H Co.,Ltd.14ea1776-ef7f-27a9-e063-6394a90afd492024-03-29WarningsExact identifier
application number: M021
HIMALAYA PINK SALT Intensive Whitening SpearmintSODIUM FLUORIDETai Guk Pharma. Co., Ltd.14eb9f74-e5f5-e199-e063-6394a90adbf62024-03-29WarningsExact identifier
application number: M021
Dentalclean Ultra Refreshing Extreme Ice Dental GelSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda1496636d-6563-d474-e063-6394a90ab73d2024-03-26WarningsExact identifier
application number: M021
Scope Stay StrongSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company142bffe1-1e8c-8567-e063-6394a90af15a2024-03-21WarningsExact identifier
application number: M021
Made by Dentists Ultra Whitening Fresh MintSODIUM FLUORIDEMADE BY DENTISTS INCdbce2aba-48db-4e78-bf79-74f34868ee372024-03-15WarningsExact identifier
application number: M021
EUTHYMOL Extraordinary Pink WhiteningSODIUM FLUORIDETai Guk Pharm. Co., Ltd.13907bf6-9a95-c0b2-e063-6394a90a40422024-03-13WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN4b307471-445d-4c51-a499-d074a8172f2010
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD4b307471-445d-4c51-a499-d074a8172f2010
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY4b307471-445d-4c51-a499-d074a8172f2010
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY4b307471-445d-4c51-a499-d074a8172f2010
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY4b307471-445d-4c51-a499-d074a8172f2010
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY4b307471-445d-4c51-a499-d074a8172f2010

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59448-100-00594480100001 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 PACK1 kit2013-07-010000-00-00NoNoCurrent