FDA.reportPublic FDA data

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
IngredientStrength
SODIUM FLUORIDE4.4 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8d3e0dd0-b584-413b-adf3-5c2d05ab72ddAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63783-403-16ORTHO GUARD473 mL in 1 BOTTLEGEL, DENTIFRICE4738

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7ORTHO GUARD (SODIUM FLUORIDE) GEL, DENTIFRICE [MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS]4
FLUORIDE IONACTIVE MOIETYQ80VPU408OORTHO GUARD (SODIUM FLUORIDE) GEL, DENTIFRICE [MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS]4
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYORTHO GUARD (SODIUM FLUORIDE) GEL, DENTIFRICE [MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS]4
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUORTHO GUARD (SODIUM FLUORIDE) GEL, DENTIFRICE [MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS]4
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEINACTIVE INGREDIENT593YOG76RNORTHO GUARD (SODIUM FLUORIDE) GEL, DENTIFRICE [MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS]4
WATERINACTIVE INGREDIENT059QF0KO0RORTHO GUARD (SODIUM FLUORIDE) GEL, DENTIFRICE [MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63783-403ORTHO GUARD (SODIUM FLUORIDE) GEL, DENTIFRICE [MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS]8Current NDC, Legacy NDC, 1 package rows20231218_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 12 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest Clean Breath PeppermintSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company4f1ef07b-ee68-e6ae-e063-6394a90af5e52026-04-10WarningsExact identifier
application number: M021
Crest Clean Breath SpearmintSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company4f20343e-6c03-48e8-e063-6294a90a8cdf2026-04-10WarningsExact identifier
application number: M021
Crest Clean Breath Smooth MintSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company4f2042b4-8eae-5c2c-e063-6394a90a640c2026-04-10WarningsExact identifier
application number: M021
Crest 3D White Advanced Arctic Fresh with Stain-Blasting FoamSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4ef4146d-6281-fe66-e063-6394a90a32c32026-04-09WarningsExact identifier
application number: M021
Crest 3D White Advanced Glamorous White with Stain-Blasting FoamSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4ef5261e-9d2f-ae05-e063-6294a90a489a2026-04-09WarningsExact identifier
application number: M021
Crest 3D White Advanced Luminous Mint Daily Whitening UpkeepSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4f0876d9-41c9-d891-e063-6394a90a1cbd2026-04-09WarningsExact identifier
application number: M021
Crest 3D White Advanced Charcoal with Stain-Blasting FoamSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4ef57a05-b9f5-42f7-e063-6294a90a5d892026-04-09WarningsExact identifier
application number: M021
Crest 3D White Advanced Radiant Mint with Stain Blasting FoamSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4ee26a82-16fd-f0fb-e063-6394a90a91d12026-04-09WarningsExact identifier
application number: M021
Crest 3D White Whitening Therapy Deep Clean CharcoalSODIUM FLUORIDEProcter & Gamble Manfuacturing Company812c1519-1a4b-2495-e053-2a91aa0a914a2026-04-09WarningsExact identifier
application number: M021
Crest 3D White Advanced Deep Clean with Stain-Blasting FoamSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4ef4e7c2-1f58-59fc-e063-6294a90ad43b2026-04-08WarningsExact identifier
application number: M021
Anticavity mouth rinse Low-foaming Spearmint779 US VARIANT ANTICAVITY MOUTH RINSE LOW-FOAMING SPEARMINTDyson Technology Limited4ef669b9-defe-8965-e063-6394a90ab3352026-04-08WarningsExact identifier
application number: M021
Crest 3D White Advanced Radiant MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf5c89efc-5fa0-2a05-e053-2a95a90a7b9c2026-04-07WarningsExact identifier
application number: M021
Crest 3D White Advanced CharcoalSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf4eb8111-53da-17ae-e053-2a95a90a11272026-04-07WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEADUSA Distribution, LLC35385ada-bd8d-4d38-9587-0256885f749f2026-04-07Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEADUSA Distribution, LLCcf0c8b48-0d1c-406a-a67d-7d16187d38d82026-04-07Warnings, Adverse reactionsExact identifier
application number: M021
Crest 3D White Arctic FreshSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyfa08a877-b9e5-4eba-b832-3a28f4f3f83c2026-04-07WarningsExact identifier
application number: M021
Anticavity FluorideSODIUM FLUORIDEFamily Dollar (FAMILY WELLNESS)63c4c0e9-84b1-4076-bdf4-7e9543b2cf462026-04-01WarningsExact identifier
application number: M021
CloSYS Silver Sensitive Mouth Rinse Fluoride RinseSODIUM FLUORIDERowpar Pharmaceuticals, Inc.98a8cee8-9f3c-4a4a-89f8-72e1f1b067962026-04-01WarningsExact identifier
application number: M021
CloSYSSODIUM FLUORIDERowpar Pharmaceuticals, Inc.5f87abb7-0e9d-6369-e053-2a91aa0a24112026-03-31WarningsExact identifier
application number: M021
Crest Clean Breath SpearmintSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company4e544d09-0cf3-f0c7-e063-6394a90a23692026-03-31WarningsExact identifier
application number: M021

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63783-403-1663783040316473 mL in 1 BOTTLE (63783-403-16) 473 ml1989-01-010000-00-00NoNoCurrent