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 50 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
United Airlines Therabody Polaris KitSODIUM MONOFLUOROPHOSPHATEWessco Internationalab667740-55ab-470e-9514-163961502ceb2023-10-26WarningsExact identifier
application number: M021
Cavity Protection Fresh MintSODIUM FLUORIDEOxyfresh Worldwide Inc0ae98f28-7e78-4379-93b0-4f2657415c4d2023-10-25WarningsExact identifier
application number: M021
Tanners Tasty Vanilla BlingSODIUM FLUORIDESheffield Pharmaceuticals LLC521fe01e-7f2e-4d79-9126-e4880cdf4e712023-10-24WarningsExact identifier
application number: M021
Tanners Tasty Ooh La La OrangeSODIUM FLUORIDESheffield Pharmaceuticals LLC6027b961-314e-4f71-8b2f-646ce80214d82023-10-24WarningsExact identifier
application number: M021
Tanners Tasty Cha Cha ChocolateSODIUM FLUORIDESheffield Pharmaceuticals LLC8609dbf3-7620-4a13-b40b-6bd705a78fb02023-10-24WarningsExact identifier
application number: M021
Glister Multi-ActionSODIUM FLUORIDEAccess Business Group LLCe3f2c049-a0f5-4649-a4aa-11bdb252f9512023-10-23WarningsExact identifier
application number: M021
UNITED Asutra TC Kit ColgateSODIUM MONOFLUOROPHOSPHATEMING FAI ENTERPRISE (CAMBODIA) CO., LTD082a581a-c7e5-e614-e063-6394a90a87da2023-10-20WarningsExact identifier
application number: M021
Plak Smacker Anti Cavity FluorideSODIUM FLUORIDEYOUNG PS ACQUISITION, LLCc6dee5fa-9cd4-4a94-9cbe-e977b2bd3dfe2023-10-16WarningsExact identifier
application number: M021
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.152d84ee-d981-4032-bfb1-a559afe71d402023-10-11WarningsExact identifier
application number: M021
Sodium FluorideSODIUM FLUORIDESafco Dental Supply LLC788080b3-fff8-4049-af98-f571824994c22023-10-11WarningsExact identifier
application number: M021
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.5c312b36-07f4-406e-b3d3-c6d1e964635d2023-10-11WarningsExact identifier
application number: M021
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.042636cf-8b61-4022-b0a1-af09c06b145b2023-10-11WarningsExact identifier
application number: M021
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.f4c3569b-7b6a-4566-9e87-492f291c51652023-10-11WarningsExact identifier
application number: M021
UNITED Asutra TC Kit ColgateSODIUM MONOFLUOROPHOSPHATEProcurall Solutions042817f9-675f-056a-e063-6394a90a2d972023-08-30WarningsExact identifier
application number: M021
Colgate Max Fresh Cool MintSODIUM FLUORIDEMission Hills S.A de C.Vd142e43f-415a-41c5-a7db-8b18a039a3232019-04-09WarningsExact 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