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		2026-10-05

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 18 of 51 · 1,013 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TheraBreath Kids Anticavity Oral Rinse Bubblegum	ANTICAVITY ORAL RINSE	Church & Dwight Co., Inc.	2770424d-7416-66d4-e063-6394a90ad4b1	2026-02-06	Warnings	Exact identifier application number: M021
Crest Pro-Health Sensitivity Whitening Plus Scope	SODIUM FLUORIDE AND POTASSIUM NITRATE	The Procter & Gamble Manufacturing Company	463b7820-a5ce-f8b5-e063-6394a90aa018	2026-02-05	Warnings	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	Publix Super Markets, Inc.	14494238-872b-49e2-8bf7-df3844a0a6c8	2026-02-05	Warnings, Adverse reactions	Exact identifier application number: M021
HAPEE EXPLOSIVE MENTHOL RED 150	SODIUM MONOFLUOROPHOSPHATE	LAMOIYAN CORPORATION	14c14694-6149-40a8-aff2-660d39f7e0c1	2026-02-05	Warnings	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	HARRIS TEETER	f759e9e4-6de2-4b80-903b-e67c06e36295	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M021
Oral Antivavity	SODIUM FLUORIDE	HARRIS TEETER	571f7628-fd59-462f-96dd-67aeaa98cff1	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	Lidl US, LLC	c47475aa-3125-410f-aa31-0add6e4ce125	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity Rinse	SODIUM FLUORIDE	Demoulas Super Markets, Inc	6391ca2e-10e8-429d-a873-238a515f9c60	2026-02-03	Warnings, Adverse reactions	Exact identifier application number: M021
Crest 3D White Brilliance Pro Ultra White	SODIUM MONOFLUOROPHOSPHATE	The Procter & Gamble Manufacturing Company	f4c02924-95ee-09d2-e053-2995a90a8121	2026-02-03		Exact identifier application number: M021
Crest 3D White Stain Eraser Icy Clean Mint	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	f5d97011-7be3-3b1c-e053-2a95a90ade86	2026-02-03		Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	Demoulas Super Markets, Inc.	c28c3475-efbb-4099-83ab-ab91bac9dfc3	2026-02-03	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity Fluoride Rinse	SODIUM FLUORIDE	Demoulas Super Markets, Inc	65abfb4d-3a1e-42df-b343-f270ce60a3bf	2026-02-03	Warnings, Adverse reactions	Exact identifier application number: M021
Crest Cavity Protection Cool Mint Gel	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	102e4d9c-0fae-d48a-e063-6294a90aac94	2026-02-03	Warnings	Exact identifier application number: M021
Crest Plus Tartar Protection	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	08767b0f-ed6e-8d32-e063-6294a90a10cd	2026-02-03	Warnings	Exact identifier application number: M021
Crest Braces Care Anticavity Fluoride Rinse	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	d8398cfd-9af6-690d-e053-2995a90a9b7c	2026-02-03	Warnings	Exact identifier application number: M021
AutoBrush bubblegum	SODIUM FLUORIDE	Lander Enterprises, LLC	2e85d6f7-2df8-4eb9-bc97-d7b7af7fb460	2026-02-03	Warnings	Exact identifier application number: M021
AutoBrush Mint	SODIUM FLUORIDE	Lander Enterprises, LLC	d859d02d-a036-4d90-bed4-9a5c31e9e1ef	2026-02-03	Warnings	Exact identifier application number: M021
Glowing White	SODIUM FLUORIDE	Demoulas Super Markets, Inc	32faf47d-b64f-4454-9f14-51503504c6b5	2026-02-03	Warnings, Adverse reactions	Exact identifier application number: M021
Sodium fluoride	SODIUM FLUORIDE	Demoulas Super Markets, Inc	2f5d3c75-1a11-47e1-b297-e2302177efe7	2026-02-03	Warnings, Adverse reactions	Exact identifier application number: M021
Anticavity	SODIUM FLUORIDE	Demoulas Super Markets, Inc	096e6a1d-316b-432a-bf27-70e8a13337cc	2026-02-03	Warnings, Adverse reactions	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