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 29 of 50 · 995 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Supersmile Professional Whitening TP Citrus Blast SODIUM MONOFLUOROPHOSPHATE Robell Research, Inc 25039552-c35d-a69d-e063-6394a90ab103 2026-01-08 Warnings Exact identifier application number: M021 Supersmile Professional Whitening TP Citrus Blast SODIUM MONOFLUOROPHOSPHATE Robell Research, Inc 2504686d-b053-51d0-e063-6394a90a789f 2026-01-08 Warnings Exact identifier application number: M021 Supersmile Professional Whitening TP Peppy Mint 8 oz SODIUM MONOFLUOROPHOSPHATE Robell Research, Inc 25121ebb-922b-719d-e063-6394a90a23d3 2026-01-08 Warnings Exact identifier application number: M021 Crest Pro-health Gum Detoxify Deep Clean STANNOUS FLUORIDE The Procter & Gamble Manufacturing Company f498b727-c38c-1d67-e053-2995a90a0f11 2026-01-08 Warnings Exact identifier application number: M021 DG health Sensitive Maximum Strength POTASSIUM NITRATE, SODIUM FLUORIDE Dolgencorp, LLC 81cd5d37-3751-625f-e053-2a91aa0a6dfd 2026-01-08 Warnings Exact identifier application number: M021 Crest 3D White Advanced Glamorous White SODIUM FLUORIDE The Procter & Gamble Manufacturing Company f5b18988-68c7-40f9-e053-2995a90a22bc 2026-01-08 Warnings Exact identifier application number: M021 CVS Restore and Defend Sensitive Whitening STANNOUS FLUORIDE CVS Pharmacy 81b72da2-7f41-74ca-e053-2a91aa0a9646 2026-01-08 Warnings Exact identifier application number: M021 Gum and Enamel Repair STANNOUS FLUORIDE CVS ccad05d4-7f05-bebd-e053-2a95a90aa52c 2026-01-08 Warnings Exact identifier application number: M021 CVS Pharmacy Pro Defense FLUORIDE CVS Pharmacy 445ec57e-dc3c-49a0-8ca9-4806fcdc0303 2026-01-08 Warnings Exact identifier application number: M021 Gum Detoxify STANNOUS FLUORIDE Walmart ad3f645d-aaf9-2800-e053-2a95a90ab62f 2026-01-08 Warnings Exact identifier application number: M021 CVS Complete Protection STANNOUS FLOURIDE CVS b681b5e4-a0e1-8d0f-e053-2a95a90aa672 2026-01-06 Warnings Exact identifier application number: M021 Complete Protection STANNOUS FLUORIDE Target 03708e08-0189-b83d-e063-6394a90a50e6 2026-01-06 Warnings Exact identifier application number: M021 Brush Buddies Mouthwash 12oz Star Wars Saber Strike Strawberry SODIUM FLUORIDE Kingkey MBC Life Technology Group co., LTD. 4998c0e6-1de3-11cd-e063-6294a90acb6f 2026-01-01 Warnings Exact identifier application number: M021 Exceed Total Care Sensitive Spearmint Tooth Polish POTASSIUM NITRATE AND SODIUM FLUORIDE Melaleuca, Inc dc620d3f-880f-df05-e053-2995a90a8409 2025-12-31 Warnings Exact identifier application number: M021 Exceed Total Care Sensitive Peppermint Tooth Polish POTASSIUM NITRATE AND SODIUM FLUORIDE Melaleuca, Inc ed2179a4-3d19-6481-e053-2995a90ad655 2025-12-31 Warnings Exact identifier application number: M021 Koala Pals Berrylicious SODIUM FLUORIDE Melaleuca, Inc. 6624be86-c9a8-53b8-e053-2a91aa0a87ef 2025-12-31 Warnings Exact identifier application number: M021 Whitening Tooth Polish SODIUM FLUORIDE Melaleuca, Inc. 6893405a-a2c4-068e-e053-2a91aa0ae5b1 2025-12-31 Warnings Exact identifier application number: M021 Gel 1100 Mint SODIUM FLUORIDE Dental Alliance Holdings LLC f125fb04-5045-5367-e053-2a95a90aa73b 2025-12-29 Warnings Exact identifier application number: M021 Gracie Square Hospital Amenity SODIUM MONOFLUOROPHOSPHATE ASP Global, LLc 89d81053-6950-465e-a5b1-cbf841d7afcb 2025-12-29 Warnings Exact identifier application number: M021 CloSYS Fluoride Rinse SODIUM FLUORIDE Rowpar Pharmaceuticals, Inc. 1a994f24-99ee-4b27-aab0-e816931a22c8 2025-12-23 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