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 29 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Supersmile Professional Whitening TP Citrus Blast	SODIUM MONOFLUOROPHOSPHATE	Robell Research, Inc	25039552-c35d-a69d-e063-6394a90ab103	2026-01-08	Warnings	Exact identifier application number: M021
Supersmile Professional Whitening TP Citrus Blast	SODIUM MONOFLUOROPHOSPHATE	Robell Research, Inc	2504686d-b053-51d0-e063-6394a90a789f	2026-01-08	Warnings	Exact identifier application number: M021
Supersmile Professional Whitening TP Peppy Mint 8 oz	SODIUM MONOFLUOROPHOSPHATE	Robell Research, Inc	25121ebb-922b-719d-e063-6394a90a23d3	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-health Gum Detoxify Deep Clean	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	f498b727-c38c-1d67-e053-2995a90a0f11	2026-01-08	Warnings	Exact identifier application number: M021
DG health Sensitive Maximum Strength	POTASSIUM NITRATE, SODIUM FLUORIDE	Dolgencorp, LLC	81cd5d37-3751-625f-e053-2a91aa0a6dfd	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Advanced Glamorous White	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	f5b18988-68c7-40f9-e053-2995a90a22bc	2026-01-08	Warnings	Exact identifier application number: M021
CVS Restore and Defend Sensitive Whitening	STANNOUS FLUORIDE	CVS Pharmacy	81b72da2-7f41-74ca-e053-2a91aa0a9646	2026-01-08	Warnings	Exact identifier application number: M021
Gum and Enamel Repair	STANNOUS FLUORIDE	CVS	ccad05d4-7f05-bebd-e053-2a95a90aa52c	2026-01-08	Warnings	Exact identifier application number: M021
CVS Pharmacy Pro Defense	FLUORIDE	CVS Pharmacy	445ec57e-dc3c-49a0-8ca9-4806fcdc0303	2026-01-08	Warnings	Exact identifier application number: M021
Gum Detoxify	STANNOUS FLUORIDE	Walmart	ad3f645d-aaf9-2800-e053-2a95a90ab62f	2026-01-08	Warnings	Exact identifier application number: M021
CVS Complete Protection	STANNOUS FLOURIDE	CVS	b681b5e4-a0e1-8d0f-e053-2a95a90aa672	2026-01-06	Warnings	Exact identifier application number: M021
Complete Protection	STANNOUS FLUORIDE	Target	03708e08-0189-b83d-e063-6394a90a50e6	2026-01-06	Warnings	Exact identifier application number: M021
Brush Buddies Mouthwash 12oz Star Wars Saber Strike Strawberry	SODIUM FLUORIDE	Kingkey MBC Life Technology Group co., LTD.	4998c0e6-1de3-11cd-e063-6294a90acb6f	2026-01-01	Warnings	Exact identifier application number: M021
Exceed Total Care Sensitive Spearmint Tooth Polish	POTASSIUM NITRATE AND SODIUM FLUORIDE	Melaleuca, Inc	dc620d3f-880f-df05-e053-2995a90a8409	2025-12-31	Warnings	Exact identifier application number: M021
Exceed Total Care Sensitive Peppermint Tooth Polish	POTASSIUM NITRATE AND SODIUM FLUORIDE	Melaleuca, Inc	ed2179a4-3d19-6481-e053-2995a90ad655	2025-12-31	Warnings	Exact identifier application number: M021
Koala Pals Berrylicious	SODIUM FLUORIDE	Melaleuca, Inc.	6624be86-c9a8-53b8-e053-2a91aa0a87ef	2025-12-31	Warnings	Exact identifier application number: M021
Whitening Tooth Polish	SODIUM FLUORIDE	Melaleuca, Inc.	6893405a-a2c4-068e-e053-2a91aa0ae5b1	2025-12-31	Warnings	Exact identifier application number: M021
Gel 1100 Mint	SODIUM FLUORIDE	Dental Alliance Holdings LLC	f125fb04-5045-5367-e053-2a95a90aa73b	2025-12-29	Warnings	Exact identifier application number: M021
Gracie Square Hospital Amenity	SODIUM MONOFLUOROPHOSPHATE	ASP Global, LLc	89d81053-6950-465e-a5b1-cbf841d7afcb	2025-12-29	Warnings	Exact identifier application number: M021 ndc (product): 59448-101
CloSYS Fluoride Rinse	SODIUM FLUORIDE	Rowpar Pharmaceuticals, Inc.	1a994f24-99ee-4b27-aab0-e816931a22c8	2025-12-23	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