EverSmile AlignerFresh Enamel Guard

Product NDC: 72655-300
11-digit product format: 726550300
Labeler code: 72655
Product ID: 72655-300_b07956ac-7866-4a89-b2cb-bf502590101d
Type: HUMAN OTC DRUG
Nonproprietary name: SODIUM FLUORIDE
Dosage form: RINSE
Route: ORAL
Labeler: Everbrands, Inc.
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-02-16
Substance: SODIUM FLUORIDE
Active strength: .225 mg/mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 30 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	72655-300-01	`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	72655-300-01	`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	72655-300-01	`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	72655-300-01	`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	72655-300-01	`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	72655-300-01	`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	72655-300-01	`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	72655-300-01	`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	72655-300-01	`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	72655-300-01	`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	72655-300-01	`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	72655-300-01	`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	72655-300-01	`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	72655-300-01	`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	72655-300-01	`1332a3947898…`	`d4bfe170f9cd…`

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: EverSmile AlignerFresh Enamel Guard
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM FLUORIDE	.225 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8ZYQ1474W7	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2597250	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
7b3d0114-dac0-4370-8545-922ec018018e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5eb9f24b-9328-475e-af0a-18021935eb6a	Product name	1	20180220
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
07cba15c-4adc-1039-9ab9-45f5b7e84f4f	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
72655-300-01	2023-07-28	C162847	48780-1	0191ceaa-618a-198a-e063-dbdaa90aec3e	ALIGNERFRESH ENAMEL GUARD FLUORIDE FOAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72655-300-01	EverSmile AlignerFresh Enamel Guard	50 mL in 1 BOTTLE, PUMP	RINSE	50		2
72655-300-01	EverSmile AlignerFresh Enamel Guard	1 in 1 PACKAGE	RINSE	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72655-300	EVERSMILE ALIGNERFRESH ENAMEL GUARD (SODIUM FLUORIDE) RINSE [EVERBRANDS, INC.]	1	Current NDC, Legacy NDC, 2 package rows	20220330_7b3d0114-dac0-4370-8545-922ec018018e.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 11 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Crest Kids Advanced Color Changing	SODIUM MONOFLUOROPHOSPHATE	Procter & Gamble Manufactura, S de R.L. de C.V.	fc86b98e-d556-4769-e053-6394a90afc6e	2026-01-08	Warnings	Exact identifier application number: M022
Care One Maximum Strength	FLUORIDE	American Sales	1b6618ea-6533-41d7-be2c-13bb9e108dc5	2026-01-08	Warnings	Exact identifier application number: M022
equate Sensitive	POTASSIUM NITRATE, SODIUM FLUORIDE	Wal-Mart Stores Inc	79899b59-3a16-6504-e053-2991aa0a895a	2026-01-08	Warnings	Exact identifier application number: M022
Crest Kids Advanced Color Changing	SODIUM MONOFLUOROPHOSPHATE	Procter & Gamble Manufactura, S de R.L. de C.V.	451283d3-78b0-8361-e063-6294a90a1fd5	2026-01-08	Warnings	Exact identifier application number: M022
CVS Maximum Strength	BENZOCAINE	CVS Pharmacy	8691d6b6-741e-47b2-8332-76742b34715f	2026-01-08	Warnings	Exact identifier application number: M022
4x Medicated Toothache and Gum Gel	BENZOCAINE	Publix Super Markets INC	16eb9d15-dba3-36e6-e063-6394a90ab859	2026-01-08	Warnings	Exact identifier application number: M022
Toothache and Gum Relief	BENZOCAINE, MENTHOL	CVS Pharmacy	814ec7bf-f825-1095-e053-2a91aa0aee59	2026-01-08	Warnings	Exact identifier application number: M022
Lemon	GLYCERIN	Sion Biotext Medical Ltd	dbd7ed86-1b92-4471-827a-89f3afa1b0dc	2026-01-08	Warnings	Exact identifier application number: M022
Sootheez Organic Wild Cherry	PECTIN	BFY LLC	47baa2a8-270c-fa07-e063-6394a90a97f6	2026-01-06	Warnings	Exact identifier application number: M022
Parodontax Gum Strengthen and Protect	CETYLPYRIDINIUM CHLORIDE	Haleon US Holdings LLC	3bb378c8-14b2-aa13-e063-6294a90a4db3	2026-01-05	Warnings	Exact identifier application number: M022
MySweetSmile Toothpaste.	MYSWEETSMILE TOOTHPASTE.	Jiangxi Dentalbright Technology Co., Ltd	478baf87-9276-7288-e063-6294a90a9e8e	2026-01-04	Warnings	Exact identifier application number: M022
MySweetSmile Mango Toothpaste.	MYSWEETSMILE MANGO TOOTHPASTE.	Jiangxi Dentalbright Technology Co., Ltd	478cbdeb-28e1-fa56-e063-6294a90af124	2026-01-04	Warnings	Exact identifier application number: M022
Smile Paint	SODIUM FLUORIDE	JABBER JAW KIDS TOOTHPASTE LLC	a7463b5c-53b2-4353-a5ea-800fbd7bd17d	2026-01-02	Warnings	Exact identifier application number: M022
Dentek Canker Cover	MENTHOL	Bershtel Enterprises	2669183c-7a58-037e-e054-00144ff88e88	2025-12-31	Warnings	Exact identifier application number: M022
AutoBrush strawberry	SODIUM FLUORIDE	Lander Enterprises, LLC	05929148-bffe-439f-a9d4-3170816c0fa2	2025-12-31	Warnings	Exact identifier application number: M022
AutoBrush Watermelon	SODIUM FLUORIDE	Lander Enterprises, LLC	37a4e712-e3b5-42f6-971c-98dea4b8dd06	2025-12-31	Warnings	Exact identifier application number: M022
AutoBrush Mint	SODIUM FLUORIDE	Lander Enterprises, LLC	6bcd35f5-18ea-4fc8-84cd-06db73f38a1e	2025-12-31	Warnings	Exact identifier application number: M022
AutoBrush Bubblegum	SODIUM FLUORIDE	Lander Enterprises, LLC	e7bf7e31-650d-4a1c-9100-48722344b201	2025-12-31	Warnings	Exact identifier application number: M022
Normal Salt	SODIUM CHLORIDE	GRAXCELL PHARMACEUTICAL, LLC	f3f09817-8a38-4aa1-956b-69d9cf695074	2025-12-25	Warnings	Exact identifier application number: M022
Sensitive Mint Tooth-paste	POTASSIUM NITRATE, SODIUM FLUORIDE	Meijer, Inc.	1e5e8b24-8304-482c-ae80-73effcc345da	2025-12-23	Warnings	Exact identifier application number: M022

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8ZYQ1474W7	SODIUM FLUORIDE	7681-49-4	SODIUM FLUORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2597250	sodium fluoride 0.05 % Oral Foam	PSN	7b3d0114-dac0-4370-8545-922ec018018e	2
2597250	sodium fluoride 0.5 MG/ML Oral Foam	SCD	7b3d0114-dac0-4370-8545-922ec018018e	2
2597250	sodium fluoride 0.05 % (fluoride ion 0.0225 % ) Oral Foam	SY	7b3d0114-dac0-4370-8545-922ec018018e	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
72655-300-01	72655030001	1 BOTTLE, PUMP in 1 PACKAGE (72655-300-01) / 50 mL in 1 BOTTLE, PUMP	2022-02-16	0000-00-00	No	No	Current