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 31 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE BUBBLEGUM	SODIUM FLUORIDE	Kingkey MBC Life Technology Group co., LTD	1ba491f4-2ad2-6e7b-e063-6394a90a9fb7	2025-12-11	Warnings	Exact identifier application number: M021
BRUSH BUDDIES HOTWHEEL ANTICAVITY FLUORIDE STRAWBERRY	SODIUM FLUORIDE	Kingkey MBC Life Technology Group co., LTD.	188ac743-3ba8-4da4-e063-6294a90a8f87	2025-12-11	Warnings	Exact identifier application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRY	SODIUM FLUORIDE	Kingkey MBC Life Technology Group Co.,Ltd	1b682604-c563-01f1-e063-6294a90ab0bd	2025-12-11		Exact identifier application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRY	SODIUM FLUORIDE	Kingkey MBC Life Technology Group Co.,Ltd	1b110db1-fcc0-377f-e063-6394a90a4d44	2025-12-11		Exact identifier application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE WATERMELON	SODIUM FLUORIDE	Kingkey MBC Life Technology Group co., LTD	1b74ecc4-a1e6-348f-e063-6294a90a5894	2025-12-11		Exact identifier application number: M021
BRUSH BUDDIES BRBIE ANTICAVITY FLUORIDE BUBBLEGUM	SODIUM FLUORIDE	Kingkey MBC Life Technology Group co., LTD.	1b68315c-6afa-3f37-e063-6294a90a14e8	2025-12-11	Warnings	Exact identifier application number: M021
ANTICAVITY FLUORIDE	SODIUM FLUORIDE	Kingkey MBC Life Technology Group co., LTD	295b88e8-c4b5-c0b0-e063-6394a90aca01	2025-12-11	Warnings	Exact identifier application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE BUBBLEGUM	SODIUM FLUORIDE	Kingkey MBC Life Technology Group co., LTD	1b74f072-c33b-c6e2-e063-6394a90ab1e6	2025-12-11	Warnings	Exact identifier application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRY	SODIUM FLUORIDE	Kingkey MBC Life Technology Group co., LTD	1ba4a807-d6d5-04a0-e063-6294a90ae04d	2025-12-11		Exact identifier application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRY	SODIUM FLUORIDE	Kingkey MBC Life Technology Group Co.,Ltd	1b617f4a-b56c-9f75-e063-6294a90a7abe	2025-12-11		Exact identifier application number: M021
BRUSH BUDDIES BRBIE ANTICAVITY FLUORIDE BUBBLEGUM	SODIUM FLUORIDE	Kingkey MBC Life Technology Group co., LTD.	1b9ec370-eadf-92c4-e063-6294a90a9055	2025-12-11	Warnings	Exact identifier application number: M021
BRUSH BUDDIES SQUISHMALLOWS ANTICAVITY FLUORIDE MINT FALVOR	SODIUM FLUORIDE	Kingkey MBC Life Technology Group co., LTD	1eb04296-ecb1-3ccc-e063-6294a90a9bda	2025-12-11	Warnings	Exact identifier application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRY	SODIUM FLUORIDE	Kingkey MBC Life Technology Group Co.,Ltd	1b9e7b21-0d34-74ec-e063-6294a90a1f59	2025-12-11		Exact identifier application number: M021
Listerine Total Care Kids Anticavity Fluoride Rinse - Berry Splash	SODIUM FLUORIDE	Kenvue Brands LLC	28986d7f-3e9a-8dfb-e063-6394a90a731e	2025-12-10	Warnings	Exact identifier application number: M021
Toms of Maine Tropical Island	ALUMINUM CHLOROHYDRATE	Colgate-Palmolive Company	0d6c51bc-5391-4533-b4fd-961dc4f36342	2025-12-10	Warnings	Exact identifier application number: M021
Business Class Kit	SODIUM MONOFLUOROPHOSPHATE	American Airlines, Inc.	483d7aec-34ac-49c5-ac0e-8fba5b4737ae	2025-12-09	Warnings	Exact identifier application number: M021
Colgate Anticavity Kit	SODIUM MONOFLUOROPHOSPHATE	Ming Fai Industrial (Shenzhen) Co. Ltd	121decce-c364-4060-87da-0c6a6cd48474	2025-12-08	Warnings	Exact identifier application number: M021
First Class Kit	SODIUM MONOFLUOROPHOSPHATE	American Airlines, Inc.	ba717de8-c3a2-41bf-85a1-aa75f9744d30	2025-12-08	Warnings	Exact identifier application number: M021
United Airlines Business Class Kit	SODIUM MONOFLUOROPHOSPHATE	United Airlines	94c5e9a4-19f3-4590-9da4-313c75261231	2025-12-08	Warnings	Exact identifier application number: M021
Dr. Jen SuperPaste Nano-Hydroxyapatite	SODIUM FLUORIDE	Dr Jen Natural, LLC	5f08d994-e458-42b2-aa39-e84fca3acf48	2025-12-05	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