EverSmile AlignerFresh Enamel Guard

Product NDC: 72655-300
Requested package NDC: 72655-300-01
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 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`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 7 of 40 · 782 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lemon Glycerin	GLYCERIN	Dynarex Corporation	99fc00ea-9d55-0380-e053-2995a90a2c0b	2026-03-24	Warnings	Exact identifier application number: M022
Dual-FormulaToothpaste for sensitive teeth	DUAL-FORMULA TOOTHPASTE FOR SENSITIVE TEETH	Hangzhou Namei Zhikang Technology Co., Ltd.	4d735f91-8abc-3a30-e063-6394a90a7639	2026-03-20	Warnings	Exact identifier application number: M022
SmileCare Mouth Ulcer Gel	MENTHOL	Yantai Aien Biotechnology Co., Ltd.	4d6db039-5b97-8f3f-e063-6294a90a9d85	2026-03-19	Warnings	Exact identifier application number: M022
Quala Topical Anesthetic Gel	BENZOCAINE	National Distribution & Contracting, Inc	9f91e609-8ca5-0492-e053-2a95a90a85d0	2026-03-17	Warnings	Exact identifier application number: M022
Quala Topical Anesthetic Gel	BENZOCAINE	National Distribution & Contracting, Inc	9f81ffa5-05fd-4eef-e053-2995a90aac3e	2026-03-17	Warnings	Exact identifier application number: M022
Quala Topical Anesthetic Gel	BENZOCAINE	National Distribution & Contracting, Inc	9f947366-9380-3fa9-e053-2a95a90ad49c	2026-03-17	Warnings	Exact identifier application number: M022
Quala Topical Anesthetic Gel	BENZOCAINE	National Distribution & Contracting, Inc	9f947672-4873-5546-e053-2a95a90a3c4b	2026-03-17	Warnings	Exact identifier application number: M022
Quala Topical Anesthetic Gel	BENZOCAINE	National Distribution & Contracting, Inc	9f9490c1-8bfe-3166-e053-2a95a90a7175	2026-03-17	Warnings	Exact identifier application number: M022
Quala Topical Anesthetic Gel	BENZOCAINE	National Distribution & Contracting, Inc	9f94b65d-47e3-9c6b-e053-2a95a90aa1f8	2026-03-17	Warnings	Exact identifier application number: M022
BencoCaine Topical Anesthetic	BENZOCAINE	Benco Dental	4d3e03ee-6e0f-c9ae-e063-6394a90a6f5b	2026-03-17	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	043c00a6-1346-7780-e063-6294a90a3d5a	2026-03-12	Warnings	Exact identifier application number: M022
ORAL PAIN RELIEF	BENZOCAINE	Nantong Health & Beyond Hygienic Products Inc.	a5f0be98-d47e-4307-8044-304a64db774b	2026-03-11	Warnings	Exact identifier application number: M022
SENSODYNE PRONAMEL Intensive Enamel Repair Whitening	POTASSIUM NITRATE AND SODIUM FLUORIDE	Haleon US Holdings LLC	a2f9d58b-671b-4427-a971-1fceff5f2323	2026-03-09	Warnings	Exact identifier application number: M022
Sore Mouth Cleanser	HYDROGEN PEROXIDE	CVS Pharmacy, Inc.	a5dbaadf-76a8-4c48-af2d-f4455e9411f0	2026-03-09	Warnings, Adverse reactions	Exact identifier application number: M022
Hydrogen Peroxide 3 Percent	HYDROGEN PEROXIDE	Sam's West, Inc	78a3e024-73da-40b7-9d9c-099fd6ca9b9e	2026-03-03	Warnings	Exact identifier application number: M022
Sore Throat	PHENOL GLYCERIN	CVS PHARMACY, INC	9683bcfb-2f7e-48a4-aa79-500ee8df099a	2026-03-02	Warnings	Exact identifier application number: M022
Spring Gene Oil Pulling Sensitivity	POTASSIUM NITRATE	Health and Natural Beauty USA Corp	294051e3-69ec-4190-8b03-fa34988376b7	2026-02-26	Warnings	Exact identifier application number: M022
Lolleez Watermelon	PECTIN	BFY LLC	4ba8af8b-5a17-8b8c-e063-6394a90a63f3	2026-02-25	Warnings	Exact identifier application number: M022
Oral Sore Antiseptic	HYDROGEN PEROXIDE, MENTHOL	H E B	f1450866-1be4-46d9-9fe4-52d699636b4f	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M022
SIGNATURE CARE SORE THROAT CHERRY FLAVOR	PHENOL	SAFEWAY	94a2c1b9-f462-4489-b84a-825a82835d30	2026-02-23	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