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 19 of 40 · 782 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Patterson Dental Topical Anesthetic	BENZOCAINE	Patterson Dental	3f19a1a7-c234-8d26-e063-6394a90ad7e9	2025-09-18	Warnings	Exact identifier application number: M022
McKesson Orasol Gel	BENZOCAINE 20%	McKesson Medical-Surgical	cc8724f4-c482-5e7d-e053-2a95a90a608f	2025-09-09	Warnings	Exact identifier application number: M022
MGC Health Drops Sugar Free Lemon Mint	MENTHOL	Medical Group Care LLC	3d70bca7-e830-e693-e063-6294a90a73f9	2025-08-28	Warnings	Exact identifier application number: M022
Exchange Select Drops Sugar Free Lemon Mint	MENTHOL	Army & Air Force Exchange Service	3d70450f-04ea-1885-e063-6294a90a05bd	2025-08-28	Warnings	Exact identifier application number: M022
Ki No Sin	CALCIUM CARBONATE	NPG Bio Pharmaceuticals Co.,Ltd.	21fa2bad-5b8b-8aac-e063-6394a90a9f49	2025-08-27	Warnings	Exact identifier application number: M022
R Cos	CALCIUM CARBONATE	NPG Bio Pharmaceuticals Co.,Ltd.	21fa767a-1344-5ed9-e063-6394a90a5fe6	2025-08-27	Warnings	Exact identifier application number: M022
Na Mi Cal	CALCIUM CARBONATE	NPG Bio Pharmaceuticals Co.,Ltd.	20cfbcd1-eb13-933c-e063-6294a90a7e59	2025-08-27	Warnings	Exact identifier application number: M022
Ki No Sin	CALCIUM CARBONATE	NPG Bio Pharmaceuticals Co.,Ltd.	20cf8f80-c638-4d94-e063-6294a90a5400	2025-08-27	Warnings	Exact identifier application number: M022
Charm Tex FLUORIDE	SODIUM MONOFLUOROPHOSPHATE	Yangzhou Hongshengding Chemical Co.,Ltd.	63a69664-8611-4d69-b871-8d1d5b553e5c	2025-08-18	Warnings	Exact identifier application number: M022
QUALITY CHOICE SALINE	SODIUM CHLORIDE	QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)	f51491d8-12ad-4b1b-a171-c621bfdcc341	2025-08-12	Warnings	Exact identifier application number: M022
MGC Health Drops Sugar Free Lemon Mint	MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	b9227966-847c-40c3-87f2-8bea3954ec84	2025-08-12	Warnings	Exact identifier application number: M022
Exchange Select Drops Sugar Free Lemon Mint	MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	5f4b1960-43ac-4c74-9410-210c48bd8a1b	2025-08-12	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	113cdb83-0fdd-40f2-8ee6-b771dca99713	2025-08-12	Warnings	Exact identifier application number: M022
CVS Pharmacy Maximum Strength	BENZOCAINE	CVS Pharmacy	13bf31c1-78e3-459f-9249-b0b6e2c17a13	2025-08-12	Warnings	Exact identifier application number: M022
Rexall Maximum Strength	BENZOCAINE	Rexall	8f6e2780-cfb7-4bef-9b7d-13cb80d8923e	2025-08-12	Warnings	Exact identifier application number: M022
Walgreens Maximum Strength	BENZOCAINE	Walgreens	8f24309d-d393-455a-a9a5-a55344adf36b	2025-08-12	Warnings	Exact identifier application number: M022
Oral Anesthetic Liquid	BENZOCAINE	Meijer, Inc.	0321c480-e150-421d-e063-6294a90ad687	2025-08-12	Warnings	Exact identifier application number: M022
Walgreens Mouth Sore Relief	BENZOCAINE	Walgreens	253d7ea2-e48e-c7d7-e063-6394a90ae001	2025-08-12	Warnings	Exact identifier application number: M022
Charm Tex FLUORIDE Gel	SODIUM FLUORIDE	Yangzhou Hongshengding Chemical Co.,Ltd.	897b0102-1c96-4699-908e-a7b7e26cd29f	2025-08-08	Warnings	Exact identifier application number: M022
Meijer Enamel Guard	POTASSIUM NITRATE, SODIUM FLUORIDE	Meijer Distribution Inc	82bc95be-0a07-3f00-e053-2a91aa0a7438	2025-08-08	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