Gracie Square Hospital Amenity

Product NDC: 59448-101
11-digit product format: 594480101
Labeler code: 59448
Product ID: 59448-101_baaa5bdf-c58a-4b39-a6a6-dda6d98229fa
Type: HUMAN OTC DRUG
Nonproprietary name: Sodium Monofluorophosphate
Dosage form: KIT
Labeler: ASP Global, LLc
Application: M021
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2016-01-18
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	59448-101	59448-101-00	D	Discontinued by firm		2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	59448-101-00	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	59448-101-00	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	59448-101-00	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	59448-101-00	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	59448-101-00	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	59448-101-00	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	59448-101-00	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	59448-101-00	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	59448-101-00	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	59448-101-00	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	59448-101-00	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	59448-101-00	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	59448-101-00	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	59448-101-00	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	59448-101-00	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	59448-101-00	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	59448-101-00	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	59448-101-00	`bd6a592717d7…`	`303034d00443…`

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: Gracie Square Hospital 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
89d81053-6950-465e-a5b1-cbf841d7afcb	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
59448-101-00	2025-12-30	C162847	48780-1	d6a99b39-ec40-a426-e053-dadaa90af4c2	Gracie Square Hospital Amenity Kit
59448-101-00	2022-01-28	C162847	48780-1	d6a99b39-ec40-a426-e053-dadaa90af4c2	Gracie Square Hospital Amenity Kit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59448-101-00	Gracie Square Hospital Amenity	1 in 1 BAG	KIT	1		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59448-101	GRACIE SQUARE HOSPITAL AMENITY (SODIUM MONOFLUOROPHOSPHATE) KIT [ASP GLOBAL, LLC]	5	Current NDC, Legacy NDC, 1 package rows	20190917_89d81053-6950-465e-a5b1-cbf841d7afcb.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 37 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cloveden 100 times higher concentrated	CETYLPYRIDINIUM CHLORIDE	Acuseplanet Inc	3c0e1862-293f-4d23-e063-6294a90a33e1	2025-08-10	Warnings	Exact identifier application number: M021
Ipana Wintergreen Fluoride	SODIUM MONOFLUOROPHOSPHATE	Maxill Inc.	5776cc3e-4fd1-4bd7-8d82-f82508e6b8d0	2025-07-28	Warnings	Exact identifier application number: M021
Ipana Bucky Beaver Bubble Gum Childrens Fluoride	SODIUM MONOFLUOROPHOSPHATE	Maxill Inc	e7aa2a8d-7140-4718-bf69-917bb50d32c7	2025-07-28	Warnings	Exact identifier application number: M021
Dubai Chocolate Flavor	ANTICAVITY TOOTHPASTE	SuperMouth, LLC.	d1615a53-ecfc-49d1-b836-f7643b9d2660	2025-07-24	Warnings	Exact identifier application number: M021
ACT Restoring Anticavity Fluoride Mint Burst	SODIUM FLUORIDE	Chattem, Inc.	0c7ede82-3b28-40ae-8dfd-cec58825f938	2025-07-23	Warnings	Exact identifier application number: M021
Dubai Chocolate Fluoride Mouthwash	ANTICAVITY MOUTHWASH	SuperMouth, LLC.	ef81a983-64c1-4913-9235-25451f023852	2025-07-23	Warnings	Exact identifier application number: M021
ACT Restoring Anticavity Fluoride Cool Mint	SODIUM FLUORIDE	Chattem, Inc.	3409a749-4a1a-4950-8c21-364d1b977af7	2025-07-22	Warnings	Exact identifier application number: M021
Act Total Care Anticavity Fluoride Fresh Mint	SODIUM FLUORIDE	Chattem, Inc.	dc209500-2bf4-42fb-b3a1-d0fb8d63dbd8	2025-07-22	Warnings	Exact identifier application number: M021
Brush Buddies Oral Rinse Sparkle Mint	SODIUM FLUORIDE	ASHTEL STUDIOS, INC	fe2c06fc-6497-4888-877f-1a88e02fad20	2025-07-15	Warnings	Exact identifier application number: M021
evo SENSITIVE WHITENING ANTI-CAVITY FLUORIDE	SODIUM FLUORIDE	Ashtel Studios, Inc.	1620c7fa-2af6-4462-af5d-9e122942788a	2025-07-15	Warnings	Exact identifier application number: M021
Dentalclean Green Diamond Alcohol Free Mouthwash	SODIUM FLUORIDE 0.05%	Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda	5653aa33-4f0e-46b2-9be0-6219143556ec	2025-07-14	Warnings	Exact identifier application number: M021
Colgate Total Gum Protect Fresh Mint	STANNOUS FLUORIDE	COLGATE PALMOLIVE COMPANY	570e3bd6-eede-4270-9d78-055aeb2b8c17	2025-07-14	Warnings	Exact identifier application number: M021
OraPro Fluoride Anticavity	FLUORIDE TOOTHPASTE	Protegera, Inc.	93b0181c-e29f-42f4-80f5-366463b68f09	2025-07-10	Warnings	Exact identifier application number: M021
Enamur Fluoride AntiCavity Toothpast	FLUORIDE TOOTHPAST	Protegera, Inc	557ced45-f54e-43d8-aa13-46f75b79367c	2025-07-10	Warnings	Exact identifier application number: M021
Super Strawberry	STRAWBERRY TOOTHPASTE	SuperMouth, LLC.	a8c2b68d-d28b-41c0-a383-cc706b25aa1a	2025-07-05	Warnings	Exact identifier application number: M021
Super Mint	SUPER MINT TOOTHPASTE	SuperMouth, LLC.	be0915f3-36c4-4200-9d15-704cfbd632b4	2025-07-05	Warnings	Exact identifier application number: M021
Super Vanilla	VANILLA TOOTHPASTE	SuperMouth, LLC.	3ddfe20a-86f1-4566-bb77-82c9749411f6	2025-07-05	Warnings	Exact identifier application number: M021
Super Chocolate	CHOCOLATE TOOTHPASTE	SuperMouth, LLC.	48607622-7c5e-4ddc-8d83-707f26c0553f	2025-07-05	Warnings	Exact identifier application number: M021
Brush Buddies ADVANCED WHITENING ANTI-CAVITY FLUORIDE PEPPERMINT	SODIUM FLUORIDE	Ashtel Studios, Inc.	13dba3ce-88a8-490c-a906-cfd206d1d290	2025-07-01	Warnings	Exact identifier application number: M021
evo ADVANCED WHITENING ANTI-CAVITY FLUORIDE PEPPERMINT	SODIUM FLUORIDE	Ashtel Studios, Inc.	baae4f4a-54ef-472a-9c94-31703435750b	2025-07-01	Warnings	Exact identifier application number: M021

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
C810JCZ56Q	SODIUM MONOFLUOROPHOSPHATE	10163-15-2	Sodium Monofluorophosphate

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
545626	sodium monofluorophosphate 0.76 % Toothpaste	PSN	89d81053-6950-465e-a5b1-cbf841d7afcb	6
545626	sodium monofluorophosphate 0.0076 MG/MG Toothpaste	SCD	89d81053-6950-465e-a5b1-cbf841d7afcb	6
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste	SY	89d81053-6950-465e-a5b1-cbf841d7afcb	6
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste	SY	89d81053-6950-465e-a5b1-cbf841d7afcb	6
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste	SY	89d81053-6950-465e-a5b1-cbf841d7afcb	6
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )Toothpaste	SY	89d81053-6950-465e-a5b1-cbf841d7afcb	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59448-101-00	59448010100	1 KIT in 1 BAG (59448-101-00) * 10 g in 1 TUBE (42555-060-45) * 59 mL in 1 TUBE * 59 mL in 1 TUBE * 65 mL in 1 BOTTLE, PLASTIC * 4.25 g in 1 TUBE * 59 mL in 1 TUBE	1 kit	2016-01-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gracie Square Hospital Amenity Kit	ASP Global, LLc \| Shengzhou Kingbird Travel Products Co., Ltd. \| Colgate-Palmolive (Thailand) LTD	2025-12-29	HUMAN OTC DRUG LABEL	6