ORTHO GUARD

Manufacturer: Massco Dental A Division of Dunagin Pharmaceuticals
Effective date: 2023-12-17
Label type: HUMAN OTC DRUG LABEL
Version: 8
Source: full-release
Hydrated at: 2026-06-01 00:04:46

Label at a glance#

ProductORTHO GUARD

Active ingredientSODIUM FLUORIDE

Label structure10 sections

Contacts and useful links#

PhoneLabel contact1-479-787-5168

Websitewww.masscodental.net

WWW.MASSCODENTAL.NET

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENT (IN EACH 10 ml)

SODIUM FLUORIDE 4.4 mg

OTC - PURPOSE SECTION

Purpose

Anticavity

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Deionized water, monosodium

phosphate, phosphoric acid, sodium benzoate, sodium

saccharin, artificial coloring, artificial flavoring.

INDICATIONS & USAGE SECTION

Use

Aids in the prevention of dental decay

WARNINGS SECTION

Warnings

When using this product, do not swallow unless to do so by a dentist or physician.

If more solution is accidentally swallowed than used for rinsing, get medical help or
contact a Poison Control Center immediately.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS: Use As Directed

ADULTS AND CHILDREN 6 YEARS AND OLDER

USE ONCE A DAY AFTER BRUSHING YOUR TEETH WITH TOOTHPASTE. VIGOROUSLY SWISH 10 MILLILITERS (10 ml ON CAP OR 2 TEASPOONS) OF RINSE BETWEEN YOUR TEETH FOR 1 MINUTE THEN SPIT OUT. DO NOT EAT OR DRINK FOR 30 MINUTES AFTER RINSING. INSTRUCT CHILDREN UNDER 12 YEARS OF AGE IN GOOD RINSING HABITS TO AVOID SWALLOWING.

CHILDREN UNDER 6

CONSULT A DENTIST OR PHYSICIAN

GENERAL PRECAUTIONS SECTION

OTHER INFORMATION

Store at room temperature.

OTC - QUESTIONS SECTION

QUESTIONS? COMMENTS?

CALL 1-479-787-5168 M-F 9 am TO 5pm CST

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ORTHOGUARD ANTI-CAVITY FLUORIDE RINSE 0.044% SODIUM FLUORIDE IN AN ACIDULATED PHOSPHATE TOPICAL SOLUTION. MANUFACTURED BY MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS, GRAVETTE AR (479) 787-5168. WWW.MASSCODENTAL.NET

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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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63783-402-16	2022-12-21	C162847	48780-1	d6a99b39-b90a-a426-e053-dadaa90af4c2	8d3e0dd0-b584-413b-adf3-5c2d05ab72dd
63783-402-16	2022-01-28	C162847	48780-1	d6a99b39-b90a-a426-e053-dadaa90af4c2	8d3e0dd0-b584-413b-adf3-5c2d05ab72dd

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63783-400-16	ORTHO GUARD	473 mL in 1 BOTTLE	GEL, DENTIFRICE	473	8
63783-401-16	ORTHO GUARD	473 mL in 1 BOTTLE	GEL, DENTIFRICE	473	8
63783-403-16	ORTHO GUARD	473 mL in 1 BOTTLE	GEL, DENTIFRICE	473	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63783-400	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
63783-401	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
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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	4
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	4
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	4
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	4
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	INACTIVE INGREDIENT	593YOG76RN	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	4

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

ORTHO GUARD
SODIUM FLUORIDE
FLUORIDE ION
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
SODIUM BENZOATE
SACCHARIN SODIUM
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63783-400	63783-400-16
63783-401	63783-401-16
63783-403	63783-403-16

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SODIUM FLUORIDE	8ZYQ1474W7	ACTIB
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
SODIUM FLUORIDE	8ZYQ1474W7	ACTIB
WATER	059QF0KO0R	IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
SODIUM FLUORIDE	8ZYQ1474W7	ACTIB
WATER	059QF0KO0R	IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 264 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SOLUTION / ORAL		660 mg	Exact identifier — unii+route 114 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, ORALLY DISINTEGRATING / ORAL		10 mg	Exact identifier — unii+route 102 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, CHEWABLE / ORAL		84 mg	Exact identifier — unii+route 102 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	POWDER, FOR SOLUTION / ORAL		199 mg	Exact identifier — unii+route 102 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GRANULE, EFFERVESCENT / ORAL	60 mg		Exact identifier — unii+route 114 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / ORAL		665 mg	Exact identifier — unii+route 102 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	PASTE / ORAL		28 mg	Exact identifier — unii+route 114 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GRANULE / ORAL	NA		Exact identifier — unii+route 114 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	ELIXIR / ORAL	5.02 mg/5ml		Exact identifier — unii+route 114 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	SUSPENSION / ORAL		104 mg	Exact identifier — unii+route 48 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	CAPSULE / ORAL	8.5 mg		Exact identifier — unii+route 114 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, CHEWABLE / ORAL		84 mg	Exact identifier — unii+route 102 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION, EXTENDED RELEASE / ORAL		24 mg	Exact identifier — unii+route 114 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	CAPSULE / ORAL	600 mg		Exact identifier — unii+route 48 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SYRUP / ORAL		24 mg	Exact identifier — unii+route 102 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 114 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SUSPENSION / ORAL	5000 mg/5ml		Exact identifier — unii+route 102 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	POWDER, FOR SOLUTION / ORAL		98 mg	Exact identifier — unii+route 114 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SOLUTION / ORAL		660 mg	Exact identifier — unii+route 114 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	ELIXIR / ORAL	15 mg/5ml		Exact identifier — unii+route 102 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SOLUTION / ORAL		660 mg	Exact identifier — unii+route 114 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	ELIXIR / ORAL	15 mg/5ml		Exact identifier — unii+route 102 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / ORAL		665 mg	Exact identifier — unii+route 102 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET, COATED / ORAL	0.2 mg		Exact identifier — unii+route 114 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET, FILM COATED / ORAL		1 mg	Exact identifier — unii+route 114 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	CAPSULE / ORAL		24 mg	Exact identifier — unii+route 102 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION / ORAL		320 mg	Exact identifier — unii+route 114 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SOLUTION / ORAL		660 mg	Exact identifier — unii+route 114 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	POWDER, FOR SUSPENSION / ORAL		160 mg	Exact identifier — unii+route 114 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	CAPSULE / ORAL		24 mg	Exact identifier — unii+route 102 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	TABLET, FILM COATED / ORAL	0.11 mg		Exact identifier — unii+route 48 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	TABLET, DELAYED RELEASE / ORAL	35 mg		Exact identifier — unii+route 48 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, FOR SUSPENSION / ORAL		6 mg	Exact identifier — unii+route 102 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, FOR SUSPENSION / ORAL		6 mg	Exact identifier — unii+route 102 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	ELIXIR / ORAL	5.02 mg/5ml		Exact identifier — unii+route 114 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	WAFER / ORAL	8 mg		Exact identifier — unii+route 102 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	LIQUID / ORAL		3 mg	Exact identifier — unii+route 102 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION, EXTENDED RELEASE / ORAL		24 mg	Exact identifier — unii+route 114 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	PASTE / ORAL		3 mg	Exact identifier — unii+route 102 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GRANULE, EFFERVESCENT / ORAL	60 mg		Exact identifier — unii+route 114 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	CAPSULE / ORAL		24 mg	Exact identifier — unii+route 102 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	SOLUTION / ORAL		1500 mg	Exact identifier — unii+route 48 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	ELIXIR / ORAL	5.02 mg/5ml		Exact identifier — unii+route 114 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 114 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	CONCENTRATE / ORAL		20 mg	Exact identifier — unii+route 114 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	TABLET / ORAL	31.72 mg		Exact identifier — unii+route 48 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	SYRUP / ORAL	20.6 mg/5ml		Exact identifier — unii+route 48 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GRANULE, EFFERVESCENT / ORAL	60 mg		Exact identifier — unii+route 114 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	CONCENTRATE / ORAL		6 mg	Exact identifier — unii+route 102 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	CONCENTRATE / ORAL		6 mg	Exact identifier — unii+route 102 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	TABLET / ORAL	31.72 mg		Exact identifier — unii+route 48 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION/ DROPS / ORAL		23 mg	Exact identifier — unii+route 114 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	TABLET / ORAL	31.72 mg		Exact identifier — unii+route 48 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET, DELAYED RELEASE / ORAL	0.34 mg		Exact identifier — unii+route 114 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	SUSPENSION / ORAL		104 mg	Exact identifier — unii+route 48 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	POWDER, FOR SOLUTION / ORAL		199 mg	Exact identifier — unii+route 102 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION/ DROPS / ORAL		23 mg	Exact identifier — unii+route 114 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET / ORAL	30 mg		Exact identifier — unii+route 114 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	TABLET, DELAYED RELEASE / ORAL	35 mg		Exact identifier — unii+route 48 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, FOR SUSPENSION / ORAL		6 mg	Exact identifier — unii+route 102 equally ranked IID candidates

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ORTHO GUARD	SODIUM FLUORIDE	Massco Dental A Division of Dunagin Pharmaceuticals	8d3e0dd0-b584-413b-adf3-5c2d05ab72dd	2023-12-17	Warnings	Exact identifier ndc (package): 63783-403-16 ndc (package): 63783-401-16 ndc (package): 63783-400-16 ndc (product): 63783-403 ndc (product): 63783-401 ndc (product): 63783-400 ndc11 (package): 63783040116 ndc11 (package): 63783040316 ndc11 (package): 63783040016 spl id: 2a1d770f-d9a7-4980-a1f2-cf4df96d0f40 spl set id: 8d3e0dd0-b584-413b-adf3-5c2d05ab72dd

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.