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 33 of 39 · 779 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Natural Cherry Honey Herb Throat Drops	MENTHOL	Ricola Ag	586b2a46-2673-4f27-a62a-2d48a9b520ab	2024-12-05	Warnings	Exact identifier application number: M022
BERRY MEDLEY THROAT DROPS	MENTHOL	Ricola Ag	a2bdd035-4678-4cff-b24f-8e2f06acad96	2024-12-05	Warnings	Exact identifier application number: M022
Orajel Toothache Rinse	BENZYL ALCOHOL, ZINC CHLORIDE	Church & Dwight Co., Inc.	41709710-5392-3119-e054-00144ff88e88	2024-11-27	Warnings	Exact identifier application number: M022
Orajel Antiseptic Alcohol-Free Mouth Sore Rinse	HYDROGEN PEROXIDE, MENTHOL	Church & Dwight Co., Inc.	99d47d6a-fa2e-d5ee-e053-2995a90aa11d	2024-11-27	Warnings	Exact identifier application number: M022
Orajel 2x Gum Pain Alcohol-Free	MENTHOL AND HYDROGEN PEROXIDE	Church & Dwight Co., Inc.	adf37010-922c-4441-93d6-1e1a95025e90	2024-11-27	Warnings	Exact identifier application number: M022
Maximum Strength Cold Sore Treatment	CAMPHOR, MENTHOL, PHENOL, WHITE PETROLATUM	Meijer Distribution Inc	9220772c-b3b7-4855-e053-2a95a90a94f6	2024-11-27	Warnings	Exact identifier application number: M022
Peroxyl Mouth Sore Mild Mint	HYDROGEN PEROXIDE	Colgate Oral Pharmaceuticals Inc.	b1e1b7c9-dea7-4d64-b6a8-5343f4176359	2024-11-25	Warnings	Exact identifier application number: M022
NICE SORE THROAT Spearmint	PHENOL	Leosons Overseas Corp	5fc68f04-ec15-11c0-e053-2a91aa0a1952	2024-11-20	Warnings	Exact identifier application number: M022
TANAC Oral Pain Reliever	BENZOCAINE	Leosons Overseas Corp	81cc61fa-31a7-2214-e053-2a91aa0ae46a	2024-11-15	Warnings	Exact identifier application number: M022
NICE SORE THROAT Honey Lemon	PHENOL	Leosons Overseas Corp	601aea98-e6ab-de6f-e053-2a91aa0a824a	2024-11-15	Warnings	Exact identifier application number: M022
NICE SORE THROAT Cherry	PHENOL	Leosons Overseas Corp	5f21694c-d1c9-0e64-e053-2a91aa0a0ff0	2024-11-15	Warnings	Exact identifier application number: M022
Sore Throat	PHENOL	Safeway, Inc.	f1dbbb8d-045f-4063-a7b3-d5b9c4b3dd7d	2024-11-14	Warnings	Exact identifier application number: M022
Sore Throat Relief Cherry	PHENOL	Best Choice (Valu Merchandisers Company)	c0a47d59-3e15-453d-97a7-d626e8650862	2024-11-14	Warnings	Exact identifier application number: M022
Listerine Gum Therapy Glacier Mint	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Kenvue Brands LLC	ed6889b6-58db-41cf-e053-2a95a90a7de2	2024-11-11	Warnings	Exact identifier application number: M022
Listerine FreshBurst Antiseptic	EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL	Kenvue Brands LLC	62b5c3ee-01cc-4c4e-9f28-e7dafa7372d8	2024-11-11	Warnings	Exact identifier application number: M022
Listerine Ultraclean Antiseptic Cool Mint	EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL	Kenvue Brands LLC	dd3729c2-fd05-4db0-a542-487bb0f9001f	2024-11-11	Warnings	Exact identifier application number: M022
Listerine Cool Mint Antiseptic	EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL	Kenvue Brands LLC	9e97e4f8-80c2-44e0-862c-0dfca392a436	2024-11-11	Warnings	Exact identifier application number: M022
Orajel 2X Medicated Gel	ORAL PAIN RELIEVER	Church & Dwight Co., Inc.	262be295-4eaf-3136-e063-6294a90a7dcc	2024-11-05	Warnings	Exact identifier application number: M022
BIOTENE Fresh Mint Original	SODIUM FLUORIDE	Haleon US Holdings LLC	1101c17f-c848-4cd5-a7cd-679b59dbe1bf	2024-11-05	Warnings	Exact identifier application number: M022
biotene	SODIUM MONOFLUOROPHOSPHATE	Haleon US Holdings LLC	a47a6502-efb2-4072-9562-cbe293531c2b	2024-11-04	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