Opalescence™

Manufacturer: Ultradent Products, Inc | Ultradent Products, Inc.
Effective date: 2026-09-09
Label type: HUMAN OTC DRUG LABEL
Version: 10
Source: daily-update
Hydrated at: 2026-09-12 01:01:16

Label at a glance#

ProductOpalescence Whitening

Active ingredientSODIUM FLUORIDE

Label structure11 sections

Indications and uses

Aids in the prevention of dental decay.

Dosage and administration

Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist or doctor.

Storage and handling

Do not use if tamper-evident seal is broken Store at room temperature Contains FD&C Yellow No. 5 (tartrazine) as a color additive

Contacts and useful links#

PhoneLabel contact1.800.552.5512

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.25% w/w

Purpose

OTC - PURPOSE SECTION

Anticavity

Uses

INDICATIONS & USAGE SECTION

Aids in the prevention of dental decay.

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age.If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
Children under 2 years of age: Consult a dentist or doctor.

Other Information

STORAGE AND HANDLING SECTION

Do not use if tamper-evident seal is broken
Store at room temperature
Contains FD&C Yellow No. 5 (tartrazine) as a color additive

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Glycerin, Water (Aqua), Silica, Sorbitol, Xylitol, Flavor (aroma), Poloxamer 407, Sodium Lauryl Sulfate, Carbomer, Sodium Benzoate, Sodium Hydroxide, Sucralose, Xanthan Gum, FD&C Blue No. 1 (CI 42090), FD&C Yellow No. 5 (CI 19140)

Questions or comments

OTC - QUESTIONS SECTION

Call toll-free 1.800.552.5512

SPL UNCLASSIFIED SECTION

Manufactured by:Ultradent Products, Inc., South Jordan, UT 84095, USA

PRINCIPAL DISPLAY PANEL - 100 ml Tube Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Opalescence™
whitening toothpaste

NET WT. 4.7 oz • 133 g • 100 ml
FLUORIDE TOOTHPASTE

Original
Cool Mint

Principal Display Panel - 100 ml Tube Box

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Data code	Data Matrix	1009124AR01		opalescence-01.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51206-302-06	2024-01-30	C162847	48780-1	1030e365-591f-111a-e063-dadaa90a10e2	Opalescence™ whitening toothpaste
51206-302-06	2024-01-30	C162847	48780-1	1030e365-591f-111a-e063-dadaa90a10e2	Opalescence™ whitening toothpaste
51206-302-07	2024-01-30	C162847	48780-1	1030e365-591f-111a-e063-dadaa90a10e2	Opalescence™ whitening toothpaste
51206-302-07	2024-01-30	C162847	48780-1	1030e365-591f-111a-e063-dadaa90a10e2	Opalescence™ whitening toothpaste
51206-302-08	2024-01-30	C162847	48780-1	1030e365-591f-111a-e063-dadaa90a10e2	Opalescence™ whitening toothpaste
51206-302-08	2024-01-30	C162847	48780-1	1030e365-591f-111a-e063-dadaa90a10e2	Opalescence™ whitening toothpaste
51206-302-09	2024-01-30	C162847	48780-1	1030e365-591f-111a-e063-dadaa90a10e2	Opalescence™ whitening toothpaste
51206-302-09	2024-01-30	C162847	48780-1	1030e365-591f-111a-e063-dadaa90a10e2	Opalescence™ whitening toothpaste
51206-302-10	2024-01-30	C162847	48780-1	1030e365-591f-111a-e063-dadaa90a10e2	Opalescence™ whitening toothpaste
51206-302-10	2024-01-30	C162847	48780-1	1030e365-591f-111a-e063-dadaa90a10e2	Opalescence™ whitening toothpaste
51206-302-11	2024-01-30	C162847	48780-1	1030e365-591f-111a-e063-dadaa90a10e2	Opalescence™ whitening toothpaste
51206-302-11	2024-01-30	C162847	48780-1	1030e365-591f-111a-e063-dadaa90a10e2	Opalescence™ whitening toothpaste

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Sodium Fluoride	ACTIVE INGREDIENT	8ZYQ1474W7	1
Fluoride Ion	ACTIVE MOIETY	Q80VPU408O	1
FD&C Blue No. 1	INACTIVE INGREDIENT	H3R47K3TBD	1
FD&C Yellow No. 5	INACTIVE INGREDIENT	I753WB2F1M	1
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	1
Methyl Salicylate	INACTIVE INGREDIENT	LAV5U5022Y	1
Saccharin Sodium	INACTIVE INGREDIENT	SB8ZUX40TY	1
Silicon Dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
Sodium Benzoate	INACTIVE INGREDIENT	OJ245FE5EU	1
Sodium Lauryl Sulfate	INACTIVE INGREDIENT	368GB5141J	1
Sorbitol	INACTIVE INGREDIENT	506T60A25R	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 · 15 matching rows.

Opalescence Whitening
Sodium Fluoride
FLUORIDE ION
GLYCERIN
SACCHARIN SODIUM
FD&C BLUE NO. 1
FD&C YELLOW NO. 5
XANTHAN GUM
SODIUM LAURYL SULFATE
WATER
SORBITOL
SODIUM BENZOATE
XYLITOL
SILICON DIOXIDE
METHYL SALICYLATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
51206-302	51206-302-07, 51206-302-10, 51206-302-06, 51206-302-08, 51206-302-09, 51206-302-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SODIUM FLUORIDE	8ZYQ1474W7	ACTIM
GLYCERIN	PDC6A3C0OX	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
FD&C YELLOW NO. 5	I753WB2F1M	IACT
XANTHAN GUM	TTV12P4NEE	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
WATER	059QF0KO0R	IACT
SORBITOL	506T60A25R	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
XYLITOL	VCQ006KQ1E	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
METHYL SALICYLATE	LAV5U5022Y	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
9	2025-11-17	full-release	2026-06-01 01:16:51

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 11 · 602 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Xylitol	XYLITOL	VCQ006KQ1E	SPRAY / SUBLINGUAL		22 mg	Exact identifier — unii candidate 84 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	PASTE, DENTIFRICE / DENTAL	18 %w/w		Exact identifier — unii+route 21 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	AEROSOL, FOAM / TOPICAL	0.27 %w/w		Exact identifier — unii candidate 203 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	TABLET / ORAL		56 mg	Exact identifier — unii candidate 203 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	SUSPENSION / ORAL	NA		Exact identifier — unii candidate 154 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	SOLUTION / ORAL		84 mg	Exact identifier — unii candidate 203 equally ranked IID candidates
Xylitol	XYLITOL	VCQ006KQ1E	FILM, SOLUBLE / ORAL		29 mg	Exact identifier — unii candidate 84 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	TABLET, FILM COATED / ORAL	0.08 mg		Exact identifier — unii candidate 203 equally ranked IID candidates
Methyl Salicylate	METHYL SALICYLATE	LAV5U5022Y	POWDER, DENTIFRICE / DENTAL	NA		Exact identifier — unii+route 14 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET, COATED / ORAL	7.93 mg		Exact identifier — unii candidate 154 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	GEL / DENTAL	0.3 %w/w		Exact identifier — unii+route 35 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET / SUBLINGUAL	0.11 mg		Exact identifier — unii candidate 154 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	CAPSULE, EXTENDED RELEASE / ORAL	0.26 mg		Exact identifier — unii candidate 154 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	PASTE, DENTIFRICE / DENTAL	0.2 %w/w		Exact identifier — unii+route 35 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 154 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	SUSPENSION / OPHTHALMIC		2 mg	Exact identifier — unii candidate 203 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	SUSPENSION/ DROPS / ORAL		22 mg	Exact identifier — unii candidate 203 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	OINTMENT / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 154 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	SOLUTION / ORAL	1 mg/1ml		Exact identifier — unii candidate 154 equally ranked IID candidates
Xylitol	XYLITOL	VCQ006KQ1E	FILM, SOLUBLE / ORAL		29 mg	Exact identifier — unii candidate 84 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	SOLUTION / OPHTHALMIC	0.6 %w/v		Exact identifier — unii candidate 203 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	LIQUID / ORAL	NA		Exact identifier — unii candidate 154 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	LOZENGE / ORAL		1264 mg	Exact identifier — unii candidate 203 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET / ORAL	180 mg		Exact identifier — unii candidate 154 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	PASTE / DENTAL	34 %w/w		Exact identifier — unii+route 14 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET / SUBLINGUAL	0.11 mg		Exact identifier — unii candidate 154 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	POWDER / ORAL	275 mg		Exact identifier — unii candidate 203 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	ENEMA / RECTAL		150 mg	Exact identifier — unii candidate 203 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	OINTMENT / DENTAL	NA		Exact identifier — unii+route 35 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	GRANULE, FOR SUSPENSION / ORAL		450 mg	Exact identifier — unii candidate 203 equally ranked IID candidates
Xylitol	XYLITOL	VCQ006KQ1E	SUSPENSION, EXTENDED RELEASE / ORAL		9000 mg	Exact identifier — unii candidate 84 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / DENTAL	15 %w/v		Exact identifier — unii+route 21 equally ranked IID candidates
Saccharin Sodium	SACCHARIN SODIUM	SB8ZUX40TY	PASTE, DENTIFRICE / DENTAL	0.2 %w/w		Exact identifier — unii+route 35 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	POWDER, FOR SOLUTION / ORAL	10 mg/5ml		Exact identifier — unii candidate 203 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	PASTE / DENTAL	14.6 %w/w		Exact identifier — unii+route 14 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		2350 mg	Exact identifier — unii candidate 203 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	CREAM / TOPICAL		46 mg	Exact identifier — unii candidate 203 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	SUSPENSION / OPHTHALMIC		2 mg	Exact identifier — unii candidate 203 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	TABLET, EXTENDED RELEASE / ORAL	2.03 mg		Exact identifier — unii candidate 154 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	GEL / TOPICAL		58 mg	Exact identifier — unii candidate 203 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	FILM, SOLUBLE / ORAL		1 mg	Exact identifier — unii candidate 203 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	PASTE, DENTIFRICE / DENTAL	1.4 %w/w		Exact identifier — unii+route 21 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	CAPSULE, EXTENDED RELEASE / ORAL	0.26 mg		Exact identifier — unii candidate 154 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	GRANULE, FOR SUSPENSION / ORAL		450 mg	Exact identifier — unii candidate 203 equally ranked IID candidates
Xylitol	XYLITOL	VCQ006KQ1E	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		72 mg	Exact identifier — unii candidate 84 equally ranked IID candidates
Xylitol	XYLITOL	VCQ006KQ1E	PASTE / ORAL		180 mg	Exact identifier — unii candidate 84 equally ranked IID candidates
Xylitol	XYLITOL	VCQ006KQ1E	GUM, CHEWING / BUCCAL		11915 mg	Exact identifier — unii candidate 84 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	GEL / DENTAL	1.47 %w/w		Exact identifier — unii+route 21 equally ranked IID candidates
FD&C Yellow No. 5	FD&C YELLOW NO. 5	I753WB2F1M	SUSPENSION / ORAL	NA		Exact identifier — unii candidate 154 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	LOTION / TOPICAL	0.3 %w/v		Exact identifier — unii candidate 203 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		36 mg	Exact identifier — unii candidate 203 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	LOTION / TOPICAL	0.3 %w/v		Exact identifier — unii candidate 203 equally ranked IID candidates
Xylitol	XYLITOL	VCQ006KQ1E	SUSPENSION, EXTENDED RELEASE / ORAL		9000 mg	Exact identifier — unii candidate 84 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	SOLUTION / OPHTHALMIC	0.6 %w/v		Exact identifier — unii candidate 203 equally ranked IID candidates
FD&C Blue No. 1	FD&C BLUE NO. 1	H3R47K3TBD	SOLUTION / DENTAL	NA		Exact identifier — unii+route 21 equally ranked IID candidates
Sodium Benzoate	SODIUM BENZOATE	OJ245FE5EU	PASTE, DENTIFRICE / DENTAL	0.5 %w/w		Exact identifier — unii+route 21 equally ranked IID candidates
Sodium Lauryl Sulfate	SODIUM LAURYL SULFATE	368GB5141J	GEL / DENTAL	1.47 %w/w		Exact identifier — unii+route 21 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	GEL / TOPICAL		58 mg	Exact identifier — unii candidate 203 equally ranked IID candidates
Silicon Dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	PASTE / DENTAL	34 %w/w		Exact identifier — unii+route 14 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	SUSPENSION / ORAL		360 mg	Exact identifier — unii candidate 203 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
Opalescence Whitening	SODIUM FLUORIDE	Ultradent Products, Inc	d07f842e-b6f1-4ae1-b576-f542ecd02dd4	2026-09-09	Warnings	Exact identifier ndc (package): 51206-302-11 ndc (package): 51206-302-06 ndc (package): 51206-302-08 ndc (package): 51206-302-10 ndc (package): 51206-302-09 ndc (package): 51206-302-07 ndc (product): 51206-302 ndc11 (package): 51206030211 ndc11 (package): 51206030209 ndc11 (package): 51206030206 ndc11 (package): 51206030207 ndc11 (package): 51206030210 ndc11 (package): 51206030208 spl id: 5b14d90f-23ec-372b-e063-6294a90a2066 spl set id: d07f842e-b6f1-4ae1-b576-f542ecd02dd4

Reported adverse events (FAERS/openFDA)#

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

Opalescence™

Label at a glance#

Indications and uses

Dosage and administration

Storage and handling

Contacts and useful links#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Active Ingredients

Purpose

Uses

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

Other Information

Inactive Ingredients

Questions or comments

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 100 ml Tube Box

Related RxNorm Concepts#

Product Linked Resources#

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Products#

NDC Codes#

Ingredients#

Source Document#

Older Hydrated Versions#

Inactive ingredient matches#

openFDA label cross-check#

Reported adverse events (FAERS/openFDA)#