FDA.reportPublic FDA data

Northside Hospital Grey Amenity Kit

Product NDC
59448-213
11-digit product format
594480213
Labeler code
59448
Product ID
59448-213_8c309db8-d099-4f8c-bdf6-1c3328dc4746
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Monofluorophospate
Dosage form
KIT
Labeler
ASP Global, LLC
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-04-01
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
Northside Hospital Grey Amenity Kit
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
545626Internal RxNorm lookup
581662Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a3cc89df-be1b-4d9a-8ba3-857885325422Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59448-011-01Northside Hospital Grey Amenity Kit53 mL in 1 BOTTLE, PLASTICGEL53 mL70 mL in 100mL1
59448-213-00Northside Hospital Grey Amenity Kit1 in 1 KITKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59448-213NORTHSIDE HOSPITAL GREY AMENITY KIT (SODIUM MONOFLUOROPHOSPATE) KIT [ASP GLOBAL, LLC]1Current NDC, 2 package rows20250426_a3cc89df-be1b-4d9a-8ba3-857885325422.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 29 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens Sanitizing WipesWALGREENS SANITIZING WIPESWalgreens42de3b25-692b-eaff-e063-6294a90a0d212026-03-11WarningsExact identifier
application number: M003
70% Isopropyl AlcoholISOPROPYL ALCOHOLAmazon.com Services LLC106f51fa-e687-470f-8ed8-35cb0565aeff2026-03-11Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLAmazon.com Services LLC4ab76d25-136d-45e2-b9d7-964777e1d8552026-03-11Warnings, Adverse reactionsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEPerrigo Direct, Inc2efcda54-b8b7-4266-89c0-7f686c7afdca2026-03-11Warnings, Adverse reactionsExact identifier
application number: M003
Alcohol Antiseptic PadsISOPROPYL ALCOHOLAcme United Corporation4cc307b9-aee2-3ce0-e063-6294a90aa1692026-03-11WarningsExact identifier
application number: M003
Isopropyl alcoholISOPROPYL ALCOHOLSalado Sales Inc.30294cad-d806-4d5b-8c86-484f22d214b62026-03-10Warnings, Adverse reactionsExact identifier
application number: M003
mild iodine tinctureIODINE AND SODIUM IODINE AND ALCOHOLKROGER COMPANY42762471-e5cb-505e-e063-6294a90afb7d2026-03-10WarningsExact identifier
application number: M003
Numstat Antiseptic and Pain-Relieving Prep PadANTISEPTIC AND PAIN-RELIEVING PREP PADSafetec of America Inc.4c9c20f2-bc17-857b-e063-6394a90a5d5c2026-03-09WarningsExact identifier
application number: M003
Eco Bandage OCEANBENZETHONIUM CHLORIDEECO Bandage LLCc7867df0-e167-4ec6-921b-6a0fb3cb06142026-03-06WarningsExact identifier
application number: M003
Eco Bandage HONEYBENZETHONIUM CHLORIDEEco Bandage LLCd2faa027-b274-43c0-9b87-85efab89fe8e2026-03-06WarningsExact identifier
application number: M003
Eco Bandage HIBISCUSBENZETHONIUM CHLORIDEEco Bandage LLC41f8716d-a970-40cd-a29d-69dafc97def82026-03-06WarningsExact identifier
application number: M003
Eco Bandage MOCHABENZETHONIUM CHLORIDEEco Bandage LLC11ec42e4-49d1-4690-80c3-784f2e30acd32026-03-06WarningsExact identifier
application number: M003
Eco Bandage SANDBENZETHONIUM CHLORIDEEco Bandage LLC5c620696-e8eb-445e-b746-5348ea37a2142026-03-06WarningsExact identifier
application number: M003
Eco Bandage sand oceanBENZETHONIUM CHLORIDEEco Bandage LLCda0c2d07-bc2a-4e7c-af45-f921375b52e12026-03-06WarningsExact identifier
application number: M003
MediChoice Antiseptic Isopropyl Alcohol Prep PadsISOPROPYL ALCOHOLO&M HALYARD, INC.20b3694e-04c7-4bca-b2ce-62ae0dec7a832026-03-05WarningsExact identifier
application number: M003
MediChoice Alcohol SwabstickISOPROPYL ALCOHOLO&M HALYARD, INC.7f78529d-df17-44b3-a890-1afa35308c672026-03-05WarningsExact identifier
application number: M003
MediChoice Alcohol Prep PadsISOPROPYL ALCOHOLO&M HALYARD, INC.f4f54448-0de0-448c-9b7b-104370953ae52026-03-05WarningsExact identifier
application number: M003
MediChoice Alcohol SwabstickISOPROPYL ALCOHOLO&M HALYARD, INC.7cee1141-4a49-4fec-a627-91a88e3d3ffc2026-03-05WarningsExact identifier
application number: M003
Loris BZK Antiseptic WipesBENZALKONIUM CHLORIDELernaPharm Loris Inc.a448de7b-4d96-4d53-ae1a-0bd38a2fb4a22026-03-05WarningsExact identifier
application number: M003
SPA HAND SANITIZER WRTER MELON SPLASHETHYL ALCOHOLRejoice International Corp.4c53620d-01ee-8ddd-e063-6294a90a8a2b2026-03-05WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSNa3cc89df-be1b-4d9a-8ba3-8578853254221
545626sodium monofluorophosphate 0.76 % ToothpastePSNa3cc89df-be1b-4d9a-8ba3-8578853254221
581662ethanol 0.7 ML/ML Topical GelSCDa3cc89df-be1b-4d9a-8ba3-8578853254221
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCDa3cc89df-be1b-4d9a-8ba3-8578853254221
581662ethanol 70 % Topical GelSYa3cc89df-be1b-4d9a-8ba3-8578853254221
581662ethyl alcohol 70 % Topical GelSYa3cc89df-be1b-4d9a-8ba3-8578853254221
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSYa3cc89df-be1b-4d9a-8ba3-8578853254221
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSYa3cc89df-be1b-4d9a-8ba3-8578853254221
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSYa3cc89df-be1b-4d9a-8ba3-8578853254221
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSYa3cc89df-be1b-4d9a-8ba3-8578853254221

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59448-011-015944800110153 mL in 1 BOTTLE, PLASTIC53 mlHistorical
59448-213-00594480213001 KIT in 1 KIT (59448-213-00) * 10 g in 1 TUBE (84132-100-10) * 60 mL in 1 BOTTLE, PLASTIC * 60 mL in 1 BOTTLE, PLASTIC * 60 mL in 1 BOTTLE, PLASTIC * 4.25 g in 1 TUBE * 53 mL in 1 BOTTLE, PLASTIC (59448-011-01) * 60 mL in 1 BOTTLE, PLASTIC1 kit2025-04-01NoNoCurrent