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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8d3e0dd0-b584-413b-adf3-5c2d05ab72dd	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

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
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 48 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EUTHYMOL Extraordinary Pink Whitening	SODIUM FLUORIDE	LG H&H CO., LTD.	13910b55-9b5d-af53-e063-6294a90acf5d	2024-03-13	Warnings	Exact identifier application number: M021
BIO SPECTRA ATTITUDE	SODIUM FLUORIDE	9055-7588 Quebec Inc. DBA Attitude	e3bb60f8-2a06-42d6-a182-8c31bb982a2a	2024-03-01	Warnings	Exact identifier application number: M021
Maximum Security	SODIUM FLUORIDE	Bob Barker Company Inc.	e29f30ec-72ea-4944-a2c2-b1696d31b639	2024-02-27	Warnings	Exact identifier application number: M021
Made by Dentists For Kids Monster Slime Sour Apple	SODIUM FLUORIDE	MADE BY DENTISTS INC	dfddc67c-3626-48c4-8120-bcc6c455d119	2024-02-23	Warnings	Exact identifier application number: M021
Orajel Gabbys Dollhouse	SODIUM FLUORIDE	Church & Dwight Co., Inc.	cd47bd1e-44ac-465f-8529-6073ade14706	2024-02-23	Warnings	Exact identifier application number: M021
Colgate Kids Maximum Cavity Protection	SODIUM FLUORIDE	Colgate-Palmolive	c44c7a7e-fc3e-a81b-1961-ff89614b678f	2024-02-22	Warnings	Exact identifier application number: M021
TheraBreath Fresh Breath Anticavity Mild Mint	SODIUM FLUORIDE	Church & Dwight Co., Inc.	19ce5324-7d8d-4d70-ad9b-238f7e612eac	2024-02-06	Warnings	Exact identifier application number: M021
Nature Mint Anticavity	SODIUM MONOFLUOROPHOSPHATE	Bob Barker Company Inc.	916891d3-5234-46a8-a492-21a31f36a852	2024-02-02	Warnings	Exact identifier application number: M021
Treatment Rinse Mint	ANTICARIES	DENTAL ALLIANCE HOLDINGS LLC	f1255065-b7c3-4eb6-e053-2995a90afcdb	2024-01-31	Warnings	Exact identifier application number: M021
Maintenance Rinse Mint	ANTICARIES	Dental Alliance Holdings LLC	f1273510-aa83-3ef9-e053-2a95a90aea27	2024-01-31	Warnings	Exact identifier application number: M021
ATOMY PROPOLIS TOOTHPAS TE 50G	SODIUM MONOFLUOROPHOSPHATE, SODIUM FLUORIDE	ATOMY CO., LTD.	98d839e3-a1aa-c83d-e053-2995a90a7e79	2024-01-30	Warnings	Exact identifier application number: M021
ATOMY PROPOLIS TOOTHPAS TE 200G	SODIUM MONOFLUOROPHOSPHATE, SODIUM FLUORIDE	ATOMY CO., LTD.	98aebbec-aec0-1478-e053-2a95a90a03ea	2024-01-30	Warnings	Exact identifier application number: M021
Toms Childrens Anticavity Mouthwash Silly Strawberry	SODIUM FLUORIDE	Tom's of Maine, Inc.	998c6f35-20f4-4cb8-bc48-6aa39e61481a	2024-01-18	Warnings	Exact identifier application number: M021
Gel-Kam Fruit and Berry	STANNOUS FLUORIDE	Colgate Oral Pharmaceuticals, Inc.	8c2c3c5c-ddef-4a4d-8bc3-5a98c577e74c	2024-01-18	Warnings	Exact identifier application number: M021
Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Gushing Grape Fluoride	SODIUM FLUORIDE	Colgate Oral Pharmaceuticals, Inc.	9a976ac8-d966-4d94-93da-45652f2d2481	2024-01-12	Warnings	Exact identifier application number: M021
Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Mint Fluoride	SODIUM FLUORIDE	Colgate Oral Pharmaceuticals, Inc.	2b4b6f9a-0e31-4891-8721-d1b9a58cca96	2024-01-12	Warnings	Exact identifier application number: M021
Colgate MaxFresh with Mini Breath Cool Mint	SODIUM FLUORIDE	Colgate-Palmolive Company	51abd6bc-7a3d-4b0e-a810-af9e94926438	2024-01-09	Warnings	Exact identifier application number: M021
Colgate Enamel Strength Mouthwash	SODIUM FLUORIDE	Colgate-Palmolive - do not use	f0cca38b-c0a3-4788-8cca-727a5684c16b	2024-01-09	Warnings	Exact identifier application number: M021
PerCara Oral Health Rinse Fresh Mint	CETYLPYRIDINIUM CHLORIDE	LEC Custom Products, Inc	bd98c654-218b-15ac-e053-2a95a90a75d1	2024-01-01	Warnings	Exact identifier application number: M021
PerCara Kids Bubble Gum	SODIUM FLUORIDE	LEC Custom Products, Inc.	be3a7272-acfb-7d14-e053-2995a90a9420	2024-01-01	Warnings	Exact identifier application number: M021

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8ZYQ1474W7	SODIUM FLUORIDE	7681-49-4	SODIUM FLUORIDE

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ORTHO GUARD - Massco Dental A Division of Dunagin Pharmaceuticals	Massco Dental A Division of Dunagin Pharmaceuticals	2023-12-17	HUMAN OTC DRUG LABEL	8