Top Quality Mfg APF

Manufacturer: Top Quality Manufacturing, Inc.
Effective date: 2022-01-20
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 20:39:28

Label at a glance#

ProductTop Quality Mfg APF

Active ingredientSODIUM FLUORIDE

Label structure8 sections

Indications and uses

A stable thixotropic fluoride treatment gel used to help prevent dental decay. For Professional Use Only. This product is not intended for home or unsupervised use.

Dosage and administration

Shake well before use. This is a one minute or four minute fluoride gel for in-office patient use. It is normally used as a preventative caries treatment two times a year. 1. After thorough prophylaxsis, fill two single or one dual tray, one third full with gel. Air dry teeth and insert trays into the mouth. 2. Instruct patient to bite down lightly but firmly for one minute (80% effectiveness) or four minutes (100...

Label contents#

Full prescribing information#

Active Ingredient:

SPL UNCLASSIFIED SECTION

Fluoride Ion 1.23%

Available from 2.09% Sodium Fluoride and Hydrofluoric Acid

Purpose:

SPL UNCLASSIFIED SECTION

Fluoride Treatment Gel

Indications and Usage:

INDICATIONS & USAGE SECTION

A stable thixotropic fluoride treatment gel used to help prevent dental decay.
For Professional Use Only. This product is not intended for home or unsupervised use.

Warnings:

WARNINGS SECTION

Keep out of reach of children.
Do not swallow. If product is accidentally swallowed in quantities greater than would normally occur with a treatment gel, seek medical help or contact a Poison Control Center right away.
Read directions carefully before using.

Dosage and Administration:

DOSAGE & ADMINISTRATION SECTION

Shake well before use. This is a one minute or four minute fluoride gel for in-office patient use. It is normally used as a preventative caries treatment two times a year.

1. After thorough prophylaxsis, fill two single or one dual tray, one third full with gel. Air dry teeth and insert trays into the mouth.

2. Instruct patient to bite down lightly but firmly for one minute (80% effectiveness) or four minutes (100% effectiveness).

3. Remove trays. Instruct patient to expectorate any excess gel and not to eat or drink for at least 30 minutes.

Other Information:

OTHER SAFETY INFORMATION

Store at controlled room temperature 59° to 86°F (15°-30°C).

Protect from freezing.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Citric Acid, Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Sodium Benzoate, Sodium Saccharin, Titanium Dioxide, Water, Xanthan Gum, Xylitol. May contain blue #1, green #3, red #3, red #40, yellow #5 (tartrazine), yellow #6 as a color additive

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TopQualityAPF

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
245593	sodium fluoride 2 % Dental Gel	PSN	3
245593	sodium fluoride 0.02 MG/MG Oral Gel	SCD	3
245593	sodium fluoride 2 % (fluoride ion 1.23 % ) Dental Gel	SY	3
245593	sodium fluoride 2.09 % (fluoride ion 1.23 % ) Dental Gel	SY	3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69301-028-15	Top Quality Mfg APF	454 g in 1 BOTTLE, PLASTIC	GEL	454		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69301-028	TOP QUALITY MFG APF (SODIUM FLUORIDE) GEL [TOP QUALITY MANUFACTURING, INC.]	3	Legacy NDC, 1 package rows	20220121_d7c56652-bc25-40ae-8894-d3c3bb1084a9.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	1
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	1
Magnesium Aluminum Silicate	INACTIVE INGREDIENT	6M3P64V0NC	1
Phosphoric Acid	INACTIVE INGREDIENT	E4GA8884NN	1
Polysorbate 20	INACTIVE INGREDIENT	7T1F30V5YH	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	1
Sodium Benzoate	INACTIVE INGREDIENT	OJ245FE5EU	1
Water	INACTIVE INGREDIENT	059QF0KO0R	1
Xanthan Gum	INACTIVE INGREDIENT	TTV12P4NEE	1
Xylitol	INACTIVE INGREDIENT	VCQ006KQ1E	1

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

Top Quality Mfg APF
Sodium Fluoride
CITRIC ACID MONOHYDRATE
MAGNESIUM ALUMINUM SILICATE
PHOSPHORIC ACID
POLYSORBATE 20
SODIUM BENZOATE
SACCHARIN SODIUM
TITANIUM DIOXIDE
WATER
XANTHAN GUM
XYLITOL
FD&C BLUE NO. 1
FD&C GREEN NO. 3
FD&C RED NO. 3
FD&C RED NO. 40
FD&C YELLOW NO. 5
FD&C YELLOW NO. 6
FLUORIDE ION

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69301-028	69301-028-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	IACT
PHOSPHORIC ACID	E4GA8884NN	IACT
POLYSORBATE 20	7T1F30V5YH	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
WATER	059QF0KO0R	IACT
XANTHAN GUM	TTV12P4NEE	IACT
XYLITOL	VCQ006KQ1E	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
FD&C GREEN NO. 3	3P3ONR6O1S	IACT
FD&C RED NO. 3	PN2ZH5LOQY	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
FD&C YELLOW NO. 5	I753WB2F1M	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
SODIUM FLUORIDE	8ZYQ1474W7	ACTIM

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 · 271 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		36 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, EFFERVESCENT / ORAL	460 mg		Exact identifier — unii candidate 88 equally ranked IID candidates
Xylitol	XYLITOL	VCQ006KQ1E	POWDER, FOR SUSPENSION / ORAL	4223 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	INJECTION / INTRAMUSCULAR	1.62 %w/v		Exact identifier — unii candidate 28 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	ENEMA / RECTAL		150 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
Phosphoric Acid	PHOSPHORIC ACID	E4GA8884NN	SOLUTION / ORAL		19 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Phosphoric Acid	PHOSPHORIC ACID	E4GA8884NN	INJECTION / SUBCUTANEOUS	ADJ PH		Exact identifier — unii candidate 28 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	GRANULE, EFFERVESCENT / ORAL	60 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	AEROSOL, FOAM / TOPICAL	0.27 %w/w		Exact identifier — unii candidate 29 equally ranked IID candidates
Magnesium Aluminum Silicate	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	GRANULE, FOR SUSPENSION / ORAL	12.5 mg/5ml		Exact identifier — unii candidate 17 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SPRAY / NASAL		9 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Magnesium Aluminum Silicate	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	TABLET / ORAL	60 mg		Exact identifier — unii candidate 17 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / INTRAMUSCULAR		28 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	GEL / TOPICAL	5 %w/w		Exact identifier — unii candidate 28 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION / INTRAMUSCULAR		26 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	POWDER / ORAL	275 mg		Exact identifier — unii candidate 29 equally ranked IID candidates
Magnesium Aluminum Silicate	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	SUSPENSION / RECTAL		14480 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION, CONCENTRATE / IRRIGATION		1 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Phosphoric Acid	PHOSPHORIC ACID	E4GA8884NN	AEROSOL, FOAM / VAGINAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	DOUCHE / VAGINAL	0.07 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION, SOLUTION / INTRAVENOUS		396 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	TABLET, DELAYED RELEASE / ORAL	0.34 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	INJECTION, SOLUTION / INTRAVENOUS		30 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Xylitol	XYLITOL	VCQ006KQ1E	SUSPENSION / ORAL		1500 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	TABLET, FILM COATED / ORAL		1 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / RECTAL		665 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	CAPSULE / ORAL	8.5 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	LIQUID / ORAL		114 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	GRANULE, FOR SUSPENSION / ORAL		450 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
Phosphoric Acid	PHOSPHORIC ACID	E4GA8884NN	SOLUTION / TOPICAL	0.23 %w/w		Exact identifier — unii candidate 28 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	INJECTION / PERIDURAL	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
Magnesium Aluminum Silicate	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	LOTION / TOPICAL	1.5 %w/w		Exact identifier — unii candidate 17 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	TABLET, FILM COATED / ORAL	0.35 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
Phosphoric Acid	PHOSPHORIC ACID	E4GA8884NN	INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS	ADJ PH		Exact identifier — unii candidate 28 equally ranked IID candidates
Phosphoric Acid	PHOSPHORIC ACID	E4GA8884NN	TABLET / ORAL	0.04 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
Polysorbate 20	POLYSORBATE 20	7T1F30V5YH	INJECTION, SOLUTION / SUBCUTANEOUS	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
Phosphoric Acid	PHOSPHORIC ACID	E4GA8884NN	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 28 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	SUSPENSION, EXTENDED RELEASE / ORAL	186.8 mg		Exact identifier — unii candidate 29 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION/ DROPS / ORAL		23 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / TOPICAL		17 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	PASTE / ORAL		1050 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	GRANULE, FOR SOLUTION / ORAL	5.5 mg/120ml		Exact identifier — unii candidate 34 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	SOLUTION / ORAL		660 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
Magnesium Aluminum Silicate	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	POWDER, FOR SUSPENSION / ORAL	NA		Exact identifier — unii candidate 17 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	CREAM / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 35 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	TABLET, COATED / ORAL	NA		Exact identifier — unii candidate 88 equally ranked IID candidates
Phosphoric Acid	PHOSPHORIC ACID	E4GA8884NN	INJECTION / INTRAMUSCULAR	ADJ PH		Exact identifier — unii candidate 28 equally ranked IID candidates
Phosphoric Acid	PHOSPHORIC ACID	E4GA8884NN	TABLET, EXTENDED RELEASE / ORAL	0.19 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / NASAL	2.8 mg/1ml		Exact identifier — unii candidate 88 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	SOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC	0.6 %w/w		Exact identifier — unii candidate 29 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	ELIXIR / ORAL	5.02 mg/5ml		Exact identifier — unii candidate 35 equally ranked IID candidates
Xylitol	XYLITOL	VCQ006KQ1E	FILM, SOLUBLE / ORAL		29 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	POWDER, FOR SOLUTION / ORAL		315 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	SOLUTION / RESPIRATORY (INHALATION)		8 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	CREAM / VAGINAL	0.49 %w/w		Exact identifier — unii candidate 88 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	CAPSULE, EXTENDED RELEASE / ORAL		101 mg	Exact identifier — unii candidate 88 equally ranked IID candidates
Phosphoric Acid	PHOSPHORIC ACID	E4GA8884NN	LOTION / TOPICAL		1 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	SOLUTION / TOPICAL	0.1 %w/v		Exact identifier — unii candidate 35 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	SUSPENSION/ DROPS / ORAL		22 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
SACCHARIN SODIUM	SACCHARIN SODIUM	SB8ZUX40TY	CAPSULE / ORAL		24 mg	Exact identifier — unii candidate 34 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
573928c0-73e5-f13f-e063-6394a90a38ca			d7c56652-bc25-40ae-8894-d3c3bb1084a9	2026-07-22	Warnings	Exact identifier spl set id: d7c56652-bc25-40ae-8894-d3c3bb1084a9

Reported adverse events (FAERS/openFDA)#

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