Home NDC 72655-300 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.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# 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 5 of 40 · 786 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sensitivity Relief Fluoride Free POTASSIUM NITRATE Health and Natural Beauty USA Corp c23b2a83-ebc3-4bcf-a216-7693944dcfa0 2026-05-22 Warnings Exact identifier application number: M022 Sensitivity and Gum with Cavity Protection POTASSIUM NITRATE AND SODIUM FLUORIDE Health and Natural Beauty USA Corp 137d6935-19a3-499d-957c-820156eec7a5 2026-05-22 Warnings Exact identifier application number: M022 SEXYTEETH MINTY T00THPASTE SEXYTEETH MINTY TOOTHPASTE WORLD DENTISTS ASSOCIATION AMERICA LIMITED 51d288c1-fe86-ffe1-e063-6394a90ab4c4 2026-05-14 Warnings Exact identifier application number: M022 Cepacol Extra Strength Sore Throat cherry BENZOCAINE AND MENTHOL Reckitt Benckiser LLC 941e36dd-d8d0-4e5c-8585-10e8f06bf8f0 2026-05-12 Warnings Exact identifier application number: M022 Cepacol Extra Strength Sore Throat honey lemon BENZOCAINE AND MENTHOL Reckitt Benckiser LLC d771095b-7de3-48f3-a125-8bc76e7d1778 2026-05-12 Warnings Exact identifier application number: M022 SEXYTEETH CHARCOAL T00THPASTE SEXYTEETH CHARCOAL TOOTHPASTE WORLD DENTISTS ASSOCIATION AMERICA LIMITED 51ab8a9a-6c12-b13b-e063-6294a90ace2a 2026-05-12 Warnings Exact identifier application number: M022 365 Whole Foods Market Spearmint Flavored Fluoride Mouthwash Anticavity FLUORIDE WHOLE FOODS 25bc7ab1-116d-143a-e063-6394a90aa970 2026-05-04 Warnings Exact identifier application number: M022 Gingicaine Gel Strawberry GINGICAINE GEL STRAWBERRY FLAVOR Gingi-Pak a Division of the Belport 2fd37612-a28b-3aa1-e054-00144ff8d46c 2026-05-01 Warnings Exact identifier application number: M022 3ECARE Dual formula WhiteningToothpaste Refill SODIUM FLUORIDE Hangzhou Namei Zhikang Technology Co., Ltd. 501df1c7-4884-bb39-e063-6294a90aaf6a 2026-04-23 Warnings Exact identifier application number: M022 Ora YoGu 4X Medicated Tooth and Gum Pain Reliever MEDICATED TOOTH AND GUM PAIN RELIEVER Kungpo Health Care & Herbal Center Inc 1f10a72f-0b49-41cb-92f9-b0160d7664de 2026-04-22 Warnings Exact identifier application number: M022 EverSmile AlignerFresh Enamel Guard SODIUM FLUORIDE Everbrands, Inc. 7b3d0114-dac0-4370-8545-922ec018018e 2026-04-21 Warnings Exact identifier application number: M022 ndc (product): 72655-300 PREOP HYDROGEN PEROXIDE Everbrands, Inc. cc5cdd29-92c1-4ce0-997e-eb624b288b09 2026-04-20 Warnings Exact identifier application number: M022 4x Medicated Toothache and Gum Cream BENZOCAINE CVS a7576238-e7c8-7e86-e053-2995a90aaeb5 2026-04-20 Warnings Exact identifier application number: M022 CVS Pharmacy Maximum Strength BENZOCAINE CVS Pharmacy 92747826-cf58-4406-b3b5-12f7c7077c2c 2026-04-20 Warnings Exact identifier application number: M022 Antiseptic EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL Family Dollar (FAMILY WELLNESS) 9f991292-bbaa-4f4e-b2cb-059d1a04849e 2026-04-20 Warnings Exact identifier application number: M022 Osstem S Sensitivity relief tooth POTASSIUM NITRATE, SODIUM FLUORIDE Osstem Pharma Co., Ltd 4f8ab179-8f29-a7cf-e063-6294a90a0c22 2026-04-15 Warnings Exact identifier application number: M022 Crest Pro-Health Gum DetoxifyWinter Mint CETYLPYRIDINIUM CHLORIDE The Procter & Gamble Manufacturing Company 4f6db58f-0b09-d155-e063-6394a90ae658 2026-04-14 Warnings Exact identifier application number: M022 Lolleez Orange Mango PECTIN BFY LLC 4f6dec8b-078a-f321-e063-6294a90a248c 2026-04-14 Warnings Exact identifier application number: M022 Crest Pro-Health Gum Restore Smooth Mint CETYLPYRIDINIUM CHLORIDE The Procter & Gamble Manufacturing Company 4f6e3b36-e565-7d27-e063-6294a90ae5ac 2026-04-14 Warnings Exact identifier application number: M022 Crest Pro-Health Nightly Bacteria Shield CETYLPYRIDINIUM CHLORIDE The Procter & Gamble Manufacturing Company 4f6ec1e0-c6b5-226f-e063-6294a90a8f14 2026-04-14 Warnings Exact identifier application number: M022
DailyMed RxNorm Mappings# 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