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 27 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Crest plus Tartar Protection Whitening	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	08776dfc-b07a-3729-e063-6394a90aeeed	2026-01-08	Warnings	Exact identifier application number: M021
Crest Plus Active Fresh plus Whitening Scope	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	17f3b749-01ea-2561-e063-6294a90a5d3b	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Advanced Deep Clean	SODIUM FLUORIDE	Procter & Gamble Manfuacturing Company	128613c4-c06b-bdf5-e063-6294a90acd34	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Brilliance Pro Rinse	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	13a01190-a6f3-17b3-e063-6294a90a36c2	2026-01-08	Warnings	Exact identifier application number: M021
HEB HEBuddy	FLUORIDE	HEB	2c972c65-34aa-4348-b997-c5e65a884575	2026-01-08	Warnings	Exact identifier application number: M021
ARC 2 in 1 Whitening and Anticavity	SODIUM MONOFLUOROPHOSPHATE	The Procter & Gamble Manufacturing Company	12634efa-35e3-76d7-e063-6294a90a3de4	2026-01-08		Exact identifier application number: M021
Crest Plus Whitening Deep Clean	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	15482445-39f3-7e02-e063-6294a90ad1dc	2026-01-08	Warnings	Exact identifier application number: M021
H E B Restore and Defend	FLUORIDE	HEB	56080493-9ab8-4b4f-be5f-7df22dee133f	2026-01-08	Warnings	Exact identifier application number: M021
Crest Plus Cinnamon Expressions plus Whitening	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	151d2a0a-448f-7744-e063-6294a90acd3b	2026-01-08	Warnings	Exact identifier application number: M021
Oral B Mouth Sore Special Care Rinse	HYDROGEN PEROXIDE	The Procter & Gamble Manufacturing Company	22e2dc15-5794-28ed-e063-6394a90a36d3	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-Health Advanced Anti-Cavity Max Cavity	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	15d70b80-3b25-bc32-e063-6394a90a163e	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Brilliance Bright Mint	SODIUM FLUORIDE	Procter & Gamble Manfuacturing Company	1dee0584-0fed-61c6-e063-6394a90adbcd	2026-01-08	Warnings	Exact identifier application number: M021
HEB Gleaming White Arctic Mint	SODIUM FLUORIDE	HEB	8248eddb-20a5-7084-e053-2991aa0a16b5	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-Health Gum Rescue Pro Soothing Clean	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	2f10c7ac-eb60-011e-e063-6394a90aca13	2026-01-08	Warnings	Exact identifier application number: M021
Crest Deep Cleanse Cavity Defense	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	2e09cb3b-cf59-15b1-e063-6394a90a5c6a	2026-01-08	Warnings	Exact identifier application number: M021
Crest Pro-Health Maximum Cavity Protection	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	2eaeddc5-1559-9378-e063-6394a90a4ed7	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Deep Stain Remover Dazzling Mint	SODIUM MONOFLUOROPHOSPHATE	The Procter & Gamble Manufacturing Company	2f11e935-1711-5f1a-e063-6294a90af7d8	2026-01-08		Exact identifier application number: M021
HEB Gleaming White Fresh Mint	SODIUM FLUORIDE	HEB	82491c8f-d2c2-2e4a-e053-2a91aa0a572f	2026-01-08	Warnings	Exact identifier application number: M021
Crest 3D White Brilliance Pro Ultra White	SODIUM MONOFLUOROPHOSPHATE	The Procter & Gamble Manufacturing Company	338acdf2-548c-0614-e063-6294a90af635	2026-01-08		Exact identifier application number: M021
KIDS Crest Advanced Sugar and Bacteria Shield	STANNOUS FLUORIDE	The Procter & Gamble Manufacturing Company	2f371af0-a2d4-25a6-e063-6394a90a923d	2026-01-08	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