Home NDC 72655-300-01 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.
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 2 of 40 · 786 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tumeez Organic Apple CALCIUM CARBONATE BFY LLC f561685a-5260-59c6-e053-2a95a90ae206 2026-08-25 Warnings Exact identifier application number: M022 Ludens Watermelon Throat Drops PECTIN Prestige Brands Holdings, Inc. adfb248a-96bb-4742-9df6-c47edccdd671 2026-08-20 Warnings Exact identifier application number: M022 Antiseptic EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL WALMART INC. (see also Equate) 584b38ce-d1ef-4ecc-a887-7c96e7f9669f 2026-08-20 Warnings Exact identifier application number: M022 Antiseptic EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL Walgreens fb93c7f6-e025-4cf2-9997-acfe9a0debdd 2026-08-19 Warnings Exact identifier application number: M022 CVS Saline NASAL CVS PHARMACY f02c41b0-c78e-41cd-aa4a-2756bbe92087 2026-08-19 Warnings Exact identifier application number: M022 Listerine UltraClean Gum Plus Whitening Protection Cool Mint Antigingivitis/ Antiplaque Mouthwash EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL Kenvue Brands LLC 5965eb2a-1261-5258-e063-6294a90a7c2d 2026-08-19 Warnings Exact identifier application number: M022 Ludens Honey Licorice Throat Drops MENTHOL Prestige Brands Holdings, Inc. 5dc2baec-a9ed-4f6b-a7ed-76a5d35739ac 2026-08-19 Warnings Exact identifier application number: M022 Ludens Dual Relief PECTIN AND MENTHOL Prestige Brands Holdings, Inc. d0213cb3-ec8e-40cc-82c9-694032f0490f 2026-08-19 Warnings Exact identifier application number: M022 CVS Health Sore Throat Fast Relief Oral Anesthetic PHENOL CVS Pharmacy,Inc. 4fb880db-2185-41ef-a5f9-8983a28d2c5b 2026-08-17 Warnings Exact identifier application number: M022 CVS Sore Throat Cherry PHENOL CVS Pharmacy,Inc. 887c68e0-ff44-4bad-b360-56fb99ed9c45 2026-08-17 Warnings Exact identifier application number: M022 CVS Sore Throat Menthol Flavor PHENOL CVS PHARMACY,INC. 665be058-b965-4b78-80b0-dd8524180932 2026-08-17 Warnings Exact identifier application number: M022 Hydrogen Peroxide 3 Percent HYDROGEN PEROXIDE Harris Teeter, LLC 7e5f175d-f0d6-4665-ac14-1873d6b99c80 2026-08-12 Warnings Exact identifier application number: M022 Gingicaine Gel Variety Pak GINGICAINE GEL VARIETY PAK Gingi-Pak a Division of the Belport 62ed4ff3-18f6-5c67-e053-2991aa0a7792 2026-08-11 Warnings Exact identifier application number: M022 Hydrogen Peroxide 3 Percent ReadyInCase HYDROGEN PEROXIDE P & L Development, LLC b0866db5-3b0d-4478-9b3b-1f077d2f5393 2026-08-06 Warnings Exact identifier application number: M022 Ollie Fresh Mint SODIUM FLUORIDE, POTASSIUM NITRATE Brio Product Group LLC. ebeec44f-3c22-43f2-9256-6ece6025c105 2026-08-06 Warnings Exact identifier application number: M022 Candee Caine Topical Anesthetic BENZOCAINE Top Quality Manufacturing, Inc. 5868c5a1-273f-f023-e063-6394a90ac9d8 2026-08-06 Warnings Exact identifier application number: M022 Candee Caine Topical Anesthetic BENZOCAINE Top Quality Manufacturing, Inc. 58690bb5-9604-26a4-e063-6394a90afdbe 2026-08-06 Warnings Exact identifier application number: M022 Candee Caine Topical Anesthetic BENZOCAINE Top Quality Manufacturing, Inc. 586918cf-7b13-5999-e063-6294a90a88a9 2026-08-06 Warnings Exact identifier application number: M022 Candee Caine Topical Anesthetic BENZOCAINE Top Quality Manufacturing, Inc. 586924a0-322d-5dc3-e063-6294a90a1556 2026-08-06 Warnings Exact identifier application number: M022 Candee Caine Topical Anesthetic BENZOCAINE Top Quality Manufacturing, Inc. 58692e90-de74-52d3-e063-6394a90a9702 2026-08-06 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