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 41 of 50 · 995 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Quip Anticavity SODIUM FLUORIDE Quip NYC Inc. b6d8a9b6-1fdd-6a54-e053-2995a90a2c1a 2025-01-30 Warnings Exact identifier application number: M021 Quip SODIUM FLUORIDE Quip NYC Inc. 714b7205-444d-929b-e053-2995a90a958e 2025-01-30 Warnings Exact identifier application number: M021 Brush Buddies MY LITTLE PONY ANTICAVITY FLUORIDE SODIUM FLUORIDE Ashtel Studios, Inc. 7e8944d3-b8d6-44e6-b38b-f80e4cd28ee4 2025-01-29 Warnings Exact identifier application number: M021 Cool sense Care Plus SODIUM FLUORIDE DOCSMEDI Co., Ltd. ea18ac56-4ef1-4bf0-8c26-6885183fd684 2025-01-22 Warnings Exact identifier application number: M021 DOCTRUST DOUBLEX Tooth SODIUM FLUORIDE DOCSMEDI Co., Ltd. aaf08481-a2ff-48f6-8611-73a469efe1db 2025-01-22 Warnings Exact identifier application number: M021 Double X CONCENTRATED CETYLPYRIDINIUM CHLORIDE DOCSMEDI Co., Ltd. 411be334-364c-4074-8d0b-8dda332f87de 2025-01-22 Warnings Exact identifier application number: M021 BIO SPECTRA ATTITUDE SODIUM FLUORIDE 9055-7588 Quebec Inc. DBA Attitude d33e3778-ba1d-4560-bafa-74f7ab88c6b5 2025-01-20 Warnings Exact identifier application number: M021 AMERFRESH FLUORIDE gel SODIUM FLUORIDE Yangzhou ONE & ONLY Personal Care Products Co., LTD 86279b4d-82e5-45b5-9ba7-94fe3620b850 2025-01-16 Warnings Exact identifier application number: M021 AMERFRESH FLUORIDE SODIUM FLUORIDE Yangzhou ONE & ONLY Personal Care Products Co., LTD 827e45bb-84c0-48ee-a60b-2cc32b8f33e3 2025-01-16 Warnings Exact identifier application number: M021 Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth SODIUM FLUORIDE Yangzhou ONE & ONLY Personal Care Products Co., LTD bb93fb1a-885a-4d2a-a1c2-3b37bc305d57 2025-01-16 Warnings Exact identifier application number: M021 Medpride SODIUM MONOFLUOROPHOSPHATE Shield Line LLC 9c1b0420-6b57-4914-99fe-df6a494815c3 2025-01-16 Warnings Exact identifier application number: M021 Sodium Fluoride SODIUM FLUORIDE Safco Dental Supply LLC 7a295974-c400-4442-9149-138a805ffb20 2025-01-09 Warnings Exact identifier application number: M021 Salivea FLUORIDE TOOTHPASTE Laclede, Inc. 6398ae96-dd38-44da-bc34-1d4d4c4a78ca 2025-01-08 Warnings Exact identifier application number: M021 EUTHYMOL Extraordinary Pink Whitening SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. 098a29d5-3836-d362-e063-6394a90a9fea 2025-01-01 Warnings Exact identifier application number: M021 PERIOE POP Sensitivity Care Prebiotic Clean Mint STANNOUS FLUORIDE Tai Guk Pharm. Co., Ltd. f4ef8ee7-7197-b3dc-e053-2a95a90a1c1b 2025-01-01 Warnings Exact identifier application number: M021 PERIOE Microbiome Sensitive Clean Mint STANNOUS FLUORIDE Tai Guk Pharm. Co., Ltd. dec29c9f-6ddb-0b4e-e053-2995a90a64b1 2025-01-01 Warnings Exact identifier application number: M021 AVON Whitening Essentials Original Cool Mint SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. 8e5de76b-535a-9c95-e053-2995a90afcab 2025-01-01 Warnings Exact identifier application number: M021 AVON Whitening Essentials Blanc Charcoal Fresh Mint SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. 8f27c88a-7a70-e00a-e053-2a95a90a95a4 2025-01-01 Warnings Exact identifier application number: M021 POP Feeling Peachy SODIUM FLUORIDE TAI GUK PHARM. CO., LTD 0abb7a95-60b1-a1f3-e063-6294a90ace0c 2025-01-01 Warnings Exact identifier application number: M021 AVON Whitening Essentials Blanc Charcoal Fresh Mint SODIUM FLUORIDE Tai Guk Pharm. Co., Ltd. 99fff177-6300-220e-e053-2a95a90a0660 2025-01-01 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