Home NDC 63783-403 ORTHO GUARD
Product NDC 63783-403
11-digit product format 637830403
Labeler code 63783
Product ID 63783-403_2a1d770f-d9a7-4980-a1f2-cf4df96d0f40
Type HUMAN OTC DRUG
Nonproprietary name SODIUM FLUORIDE
Dosage form GEL, DENTIFRICE
Route ORAL
Labeler Massco Dental A Division of Dunagin Pharmaceuticals
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 1989-01-01
Substance SODIUM FLUORIDE
Active strength 4.4 mg/10mL
NDC exclude flag No
Listing certified through 2026-12-31
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 ORTHO GUARD
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE 4.4 mg/10mL
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 SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63783-403-16 ORTHO GUARD 473 mL in 1 BOTTLE GEL, DENTIFRICE 473 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SODIUM FLUORIDE ACTIVE INGREDIENT 8ZYQ1474W7 ORTHO GUARD (SODIUM FLUORIDE) GEL, DENTIFRICE [MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS] 4 FLUORIDE ION ACTIVE MOIETY Q80VPU408O ORTHO GUARD (SODIUM FLUORIDE) GEL, DENTIFRICE [MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS] 4 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY ORTHO GUARD (SODIUM FLUORIDE) GEL, DENTIFRICE [MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS] 4 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU ORTHO GUARD (SODIUM FLUORIDE) GEL, DENTIFRICE [MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS] 4 SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE INACTIVE INGREDIENT 593YOG76RN ORTHO GUARD (SODIUM FLUORIDE) GEL, DENTIFRICE [MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS] 4 WATER INACTIVE INGREDIENT 059QF0KO0R ORTHO GUARD (SODIUM FLUORIDE) GEL, DENTIFRICE [MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63783-403 ORTHO GUARD (SODIUM FLUORIDE) GEL, DENTIFRICE [MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS] 8 Current NDC, Legacy NDC, 1 package rows 20231218_8d3e0dd0-b584-413b-adf3-5c2d05ab72dd.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 43 of 50 · 995 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Listerine Total Care Zero Alcohol Anticavity Fresh Mint SODIUM FLUORIDE Kenvue Brands LLC 4b594a6e-db1d-443b-bfa7-23ee15749f47 2024-12-19 Warnings Exact identifier application number: M021 NewYork-Presbyterian Amenity SODIUM MONOFLUOROPHOSPATE ASP Global, LLc 4b307471-445d-4c51-a499-d074a8172f20 2024-12-17 Warnings Exact identifier application number: M021 Colgate Anticavity SODIUM MONOFLUOROPHOSPHATE Colgate-Palmolive (Thailand) Limited - Branch 5bc0b430-6f68-4e52-a1da-de19136eaeac 2024-12-09 Warnings Exact identifier application number: M021 CURODONT REPAIR FLUORIDE PLUS SODIUM FLUORIDE CREDENTIS AG 03ec09f9-4281-9ccb-e063-6294a90aadd8 2024-12-01 Warnings Exact identifier application number: M021 CURODONT PROTECT STANNOUS FLUORIDE CREDENTIS AG 03ec591c-68c3-a380-e063-6394a90a131a 2024-12-01 Warnings Exact identifier application number: M021 ACT Kids Anticavity Fluoride Bubble Gum Blowout SODIUM FLUORIDE Chattem, Inc. 61f3a3e6-645b-4368-b1d5-7de1fc14542e 2024-12-01 Warnings Exact identifier application number: M021 SparkleFresh Flouride Toothpaste SODIUM MONOFLUOROPHOSPHATE Medline Industries, LP 1565528b-89f2-4c97-b294-15b6ebd3f80e 2024-11-26 Warnings Exact identifier application number: M021 Rembrandt Intense Stain SODIUM FLUORIDE Ranir LLC 55dcd063-5661-35aa-e054-00144ff8d46c 2024-11-26 Warnings Exact identifier application number: M021 Firefly Anticavity Fluoride SODIUM FLUORIDE Ranir LLC 9f98913f-6754-4e1c-98cf-b89fe87750f8 2024-11-25 Warnings Exact identifier application number: M021 Colgate Total SF Clean Mint STANNOUS FLUORIDE Colgate-Palmolive Company 88f87f7a-5b2d-47c9-8830-6b88b4ddbb59 2024-11-25 Warnings Exact identifier application number: M021 Firefly Bubble Gum natural fluoride SODIUM FLUORIDE Ranir LLC 0c85d273-3b98-43ea-81ba-c90f70ab72f8 2024-11-25 Warnings Exact identifier application number: M021 Firefly Bubble Gum natural fluoride SODIUM FLUORIDE Ranir LLC 2a882210-49e6-4b9c-a2c6-eaa37b6514c3 2024-11-25 Warnings Exact identifier application number: M021 Pepsodent Complete Care Original SODIUM FLUORIDE Church & Dwight Co., Inc. 3c6931cb-0ec9-41bb-b410-c355573aab57 2024-11-21 Warnings Exact identifier application number: M021 Firefly Strawberry Natural Fluoride SODIUM FLUORIDE Ranir LLC 8ee37955-fe1a-4964-ac29-d1d7dfb694cc 2024-11-21 Warnings Exact identifier application number: M021 Firefly Anticavity Fluoride SODIUM FLUORIDE Ranir LLC abdc7f79-5f87-4307-8ddd-e6281ac67a04 2024-11-20 Warnings Exact identifier application number: M021 AIM Bubble Berry SODIUM FLUORIDE Church & Dwight Co., Inc. c83ccdea-d75f-4084-853e-ed4bab9a12d4 2024-11-20 Warnings Exact identifier application number: M021 AIM TARTAR CONTROL Plus Mouthwash and Whitening SODIUM FLUORIDE Church & Dwight Co., Inc. 1d0fc71c-d28e-4afa-e054-00144ff8d46c 2024-11-20 Warnings Exact identifier application number: M021 Advance White Tartar Control Breath Freshening SODIUM FLUORIDE Church & Dwight Co., Inc. aa8be8f5-ba46-4b1b-afaa-58fddf8f8780 2024-11-20 Warnings Exact identifier application number: M021 Enamel Defense SODIUM FLUORIDE Church & Dwight Co., Inc. 9e8f1ce9-b161-50db-e053-2995a90ad32b 2024-11-20 Warnings Exact identifier application number: M021 Rembrandt Deeply White Plus Peroxide SODIUM MONOFLUOROPHOSPHATE Ranir LLC bf7da007-ab9d-4631-bc28-6ca245fd6265 2024-11-20 Warnings Exact identifier application number: M021
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63783-403-16 63783040316 473 mL in 1 BOTTLE (63783-403-16) 473 ml 1989-01-01 0000-00-00 No No Current