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
Identifier	FDA.report destination
545626	Internal RxNorm lookup
581662	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
a3cc89df-be1b-4d9a-8ba3-857885325422	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59448-011-01	Northside Hospital Grey Amenity Kit	53 mL in 1 BOTTLE, PLASTIC	GEL	53 mL	70 mL in 100mL	1
59448-213-00	Northside Hospital Grey Amenity Kit	1 in 1 KIT	KIT	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59448-213	NORTHSIDE HOSPITAL GREY AMENITY KIT (SODIUM MONOFLUOROPHOSPATE) KIT [ASP GLOBAL, LLC]	1	Current NDC, 2 package rows	20250426_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 105 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Novex Hand Sanitizer	BENZALKONIUM CHLORIDE	Natural Essentials, Inc.	8b53dde5-c9f6-41c4-8ddb-bf0bf67008d3	2024-03-20	Warnings	Exact identifier application number: M003
Antiseptic	BENZALKONIUM CHLORIDE 0.13%	Trifecta Pharmaceuticals USA, LLC.	13f1c70f-3b44-8eef-e063-6294a90af634	2024-03-18	Warnings	Exact identifier application number: M003
Burn Cream	BENZALKONIUM CHLORIDE, LIDOCAINE HCI	Trifecta Pharmaceuticals USA LLC	1308ce91-2858-310a-e063-6394a90a6810	2024-03-06	Warnings	Exact identifier application number: M003
Instant Hand Sanitizer - Cocoa Butter	ETHYL ALCOHOL	Rejoice International, Inc.	97dee45e-53be-4b37-a427-fc24388c0e05	2024-02-28	Warnings	Exact identifier application number: M003
Instant Hand Sanitizer Aloe Vera	ETHYL ALCOHOL	Rejoice International, Inc.	1e28454c-f5d8-4d6e-91f9-bc4501b027c1	2024-02-28	Warnings	Exact identifier application number: M003
Instant Hand Sanitizer - Clear	ETHYL ALCOHOL	Rejoice International, Inc.	f0e637d9-d61e-466d-9e05-f906639dbaca	2024-02-28	Warnings	Exact identifier application number: M003
Instant Hand Sanitizer	ETHYL ALCOHOL	Rejoice International, Inc.	07b163e4-8f67-44e7-b5ef-f237023080e0	2024-02-28	Warnings	Exact identifier application number: M003
Instant Hand Sanitizer - Ice Clear	ETHYL ALCOHOL	Rejoice International, Inc.	605ec88a-2f4c-4716-8522-eb2748b43398	2024-02-28	Warnings	Exact identifier application number: M003
Instant Hand Sanitizer - Original	ETHYL ALCOHOL	Rejoice International, Inc.	bb9cc886-275e-4996-99dc-529f928b4905	2024-02-28	Warnings	Exact identifier application number: M003
Liquid Hand Cleanse	TRICLOSAN	Rejoice International, Inc.	23ff5450-8308-41c0-9052-1ac4c4433d6c	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Antibacterial Hand Cleanse Original	TRICLOSAN	Rejoice International, Inc.	b5ce6663-fe82-4da1-923e-acea293d7a00	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Antibacterial Hand Cleanse Strawberry Pomegranate	TRICLOSAN	Rejoice International, Inc.	b68a7d64-2650-4fc6-a89e-05de9098a2a3	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Antibacterial Hand Cleanse Mountain Spring	TRICLOSAN	Rejoice International, Inc.	c31723d5-a313-448a-8b69-ca5f8dec25ed	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Foam Antibacterial Hand Wash Pink Cherry Blossom	BENZALKONIUM CHLORIDE	Rejoice International	a9a1467c-abcc-4ccb-88f6-430279609788	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Foam Antibacterial Hand Wash Refill Pink Cherry Blossom	BENZALKONIUM CHLORIDE	Rejoice International	9fa9d955-7167-4a0a-935b-2a600f439eb0	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Foam Antibacterial Hand Wash Refill Vanilla Passion Flower	BENZALKONIUM CHLORIDE	Rejoice International	157a14bf-f46e-49f8-96f4-a6c472eb5cb8	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Foaming Hand Sanitizer	BENZALKONIUM CHLORIDE	Rejoice International	3082cbbb-a0ed-45eb-a116-ad1c65357dd1	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Foam Antibacterial Hand Wash Refill Wild Berry Blast	BENZALKONIUM CHLORIDE	Rejoice International	45b3ca49-edb4-4840-b857-d24045494a3a	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Foam Antibacterial Hand Wash Vanilla Passion Flower	BENZALKONIUM CHLORIDE	Rejoice International	4890f81e-7994-4ea2-9412-5614c405a2a3	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Foam Antibacterial Hand Wash Wild Berry Blast	BENZALKONIUM CHLORIDE	Rejoice International	5c109f7c-1f4d-484a-b6ea-3bbcf572bbac	2024-02-28	Warnings	Exact identifier application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
581662	ethanol 70 % Topical Gel	PSN	a3cc89df-be1b-4d9a-8ba3-857885325422	1
545626	sodium monofluorophosphate 0.76 % Toothpaste	PSN	a3cc89df-be1b-4d9a-8ba3-857885325422	1
581662	ethanol 0.7 ML/ML Topical Gel	SCD	a3cc89df-be1b-4d9a-8ba3-857885325422	1
545626	sodium monofluorophosphate 0.0076 MG/MG Toothpaste	SCD	a3cc89df-be1b-4d9a-8ba3-857885325422	1
581662	ethanol 70 % Topical Gel	SY	a3cc89df-be1b-4d9a-8ba3-857885325422	1
581662	ethyl alcohol 70 % Topical Gel	SY	a3cc89df-be1b-4d9a-8ba3-857885325422	1
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste	SY	a3cc89df-be1b-4d9a-8ba3-857885325422	1
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste	SY	a3cc89df-be1b-4d9a-8ba3-857885325422	1
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste	SY	a3cc89df-be1b-4d9a-8ba3-857885325422	1
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )Toothpaste	SY	a3cc89df-be1b-4d9a-8ba3-857885325422	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
59448-011-01	59448001101	53 mL in 1 BOTTLE, PLASTIC	53 ml				Historical
59448-213-00	59448021300	1 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, PLASTIC	1 kit	2025-04-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Northside Hospital Grey Amenity Kit	ASP Global, LLC \| ALLIANCE FORMULATIONS	2025-04-09	HUMAN OTC DRUG LABEL	1