Home NDC 51206-312 Opal by Opalescence Original
Product NDC 51206-312
11-digit product format 512060312
Labeler code 51206
Product ID 51206-312_5b14e96f-d015-5738-e063-6294a90ac014
Type HUMAN OTC DRUG
Nonproprietary name Sodium Fluoride
Dosage form GEL, DENTIFRICE
Route DENTAL
Labeler Ultradent Products, Inc.
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-11-19
Marketing end 2029-02-21
Substance SODIUM FLUORIDE
Active strength 1.1 mg/g
NDC exclude flag No
Current FDA listing Yes 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 Opal by Opalescence Original Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE 1.1 mg/g
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 1044547 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51206-312-01 Opal by Opalescence Original 1 in 1 CARTON GEL, DENTIFRICE 1 5 51206-312-01 Opal by Opalescence Original 133 g in 1 TUBE GEL, DENTIFRICE 133 5 51206-312-02 Opal by Opalescence Original 1 in 1 CARTON GEL, DENTIFRICE 1 5 51206-312-02 Opal by Opalescence Original 3 in 1 PACKAGE, COMBINATION GEL, DENTIFRICE 3 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51206-312 OPAL BY OPALESCENCE ORIGINAL (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.] 4 Current NDC, 4 package rows 20250402_5c3bf8fc-2e8f-4a58-bcbf-e47540072a49.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 10 of 50 · 995 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Frida Fluoride Sweet Mint SODIUM FLUORIDE Fridababy, LLC 4f8b5a39-5d79-72cd-e063-6394a90a475c 2026-05-06 Warnings Exact identifier application number: M021 Frida Fluoride Bubble Mint SODIUM FLUORIDE Fridababy, LLC 4f8b9af3-e4b3-b5e0-e063-6394a90a1068 2026-05-06 Warnings Exact identifier application number: M021 Frida Fluoride Strawberry Toothbrush Set SODIUM FLUORIDE Fridababy, LLC 4f8ba14f-60ea-c2a8-e063-6394a90a7702 2026-05-06 Warnings Exact identifier application number: M021 Frida Fluoride Strawberry SODIUM FLUORIDE Fridababy, LLC 4f814a62-8f91-8ea6-e063-6294a90a69eb 2026-05-06 Warnings Exact identifier application number: M021 Gum Health Detoxify STANNOUS FLUORIDE Meijer, Inc 41d70733-a223-40fb-e063-6294a90a1397 2026-05-06 Warnings Exact identifier application number: M021 Colgate Kids Unicorn Alcohol Free SODIUM FLUORIDE Colgate-Palmolive Company 133acaff-7205-80d7-e91d-3eb37087cae4 2026-05-05 Warnings Exact identifier application number: M021 Crest 3D White Stain Eraser SODIUM FLUORIDE Procter & Gamble Manufactura, S. de R.L. de C.V. fdefffbd-9c05-fa30-e053-6394a90a34bc 2026-05-05 Warnings Exact identifier application number: M021 Frida Fluoride Watermelon SODIUM FLUORIDE Fridababy, LLC 4f8b49dc-e9e4-c341-e063-6294a90adb5a 2026-05-05 Warnings Exact identifier application number: M021 White Glo Extreme White Whitening SODIUM MONOFLUOROPHOSPHATE White Glo USA Inc 4a2e0a8d-420e-4c07-aa43-386d05dab472 2026-04-30 Warnings Exact identifier application number: M021 Equate Pro-Advanced TP Equate Pro-Advanced TP STANNOUS FLUORIDE Walmart Inc. 1e6561fb-4e3b-40ba-e063-6294a90a2690 2026-04-29 Warnings Exact identifier application number: M021 Crest Cavity Protection Regular SODIUM FLUORIDE Procter & Gamble Manufactura, S. de R.L. de C.V. 852889b4-59ba-4592-b4fc-c0127a1ad075 2026-04-28 Warnings Exact identifier application number: M021 Crest Complete Multi-Benefit Whitening plus Scope SODIUM FLUORIDE Procter & Gamble Manufactura, S. de R.L. de C.V. 0206710a-707f-4aa9-96b9-86240c1275dc 2026-04-28 Warnings Exact identifier application number: M021 Alcohol Free Refreshing Mint SODIUM FLUORIDE H E B cedf7c08-7412-4733-9b67-225b331cec8c 2026-04-27 Warnings, Adverse reactions Exact identifier application number: M021 anzoon ANTIBACTERIAL MOUTH WASH CETYLPYRIDINIUM CHLORIDE Shandong AZC Biotechnology Co.,Ltd. 507c6896-2806-790c-e063-6394a90ac5ce 2026-04-27 Warnings Exact identifier application number: M021 DELTA COMFORT PLUS AMENITY SODIUM MONOFLUOROPHOSPHATE Buzz Products Inc. 26434794-ae02-0f58-e063-6294a90ad85e 2026-04-24 Warnings Exact identifier application number: M021 A and H Plus Therabreath Breath Freshners SODIUM FLUORIDE Church & Dwight Co., Inc. 18d6073e-b1ee-47d2-9758-2cf04f3cf3ca 2026-04-23 Warnings Exact identifier application number: M021 Fluoride SODIUM FLUORIDE McKesson 5025e58e-e59c-07b6-e063-6394a90ac1e8 2026-04-23 Warnings Exact identifier application number: M021 PRO-SYS SENSITIVITY - MINT (OTC) Benco Dental 4e46847e-8c1d-c988-e063-6394a90a8e50 2026-04-22 Warnings Exact identifier application number: M021 Anticavity Fluoride Rinse SODIUM FLUORIDE H E B 87327a36-a314-4daa-83b6-b4bd3e26bba2 2026-04-22 Warnings, Adverse reactions Exact identifier application number: M021 Anticavity SODIUM FLUORIDE H E B 8df324a7-9204-40f3-8ddb-1656286d7d4e 2026-04-22 Warnings, Adverse reactions Exact identifier application number: M021
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51206-312-01 51206031201 1 TUBE in 1 CARTON (51206-312-01) / 133 g in 1 TUBE 1 tube 2023-11-19 2029-02-21 No No Historical 51206-312-02 51206031202 3 CARTON in 1 PACKAGE, COMBINATION (51206-312-02) / 1 TUBE in 1 CARTON / 133 g in 1 TUBE 3 carton 2023-11-19 2029-02-21 No No Historical