Opalescence™ Whitening Toothpaste Original Cool Mint

Manufacturer: Ultradent Products, Inc.
Effective date: 2026-09-09
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: daily-update
Hydrated at: 2026-09-12 01:01:21

Label at a glance#

ProductOpalescence Whitening Cool Mint

Active ingredientSODIUM FLUORIDE

Label structure10 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 0.24% w/w

Purpose

OTC - PURPOSE SECTION

Anticavity

Uses

INDICATIONS & USAGE SECTION

Aids in the prevention of dental decay

Warnings

WARNINGS SECTION

Warnings

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

Questions or Comments

OTC - QUESTIONS SECTION

Call toll-free 1.800.552.5512

PRINCIPAL DISPLAY PANEL - 4.7 oz Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Opalescence Whitening Toothpaste

Original

Cool Mint

Fluoride Toothpaste

NET WT. 4.7 oz Opalescence Whitening Toothpaste Original Cool Mint_4.7 oz Tube Carton

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Data code	Data Matrix	1007639AR04		Opalescence Whitening Toothpaste Original Cool Mint_4.7 oz Tube Carton.jpg

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

Opalescence Whitening Cool Mint
Sodium Fluoride
FLUORIDE ION
SODIUM LAURYL SULFATE
FD&C YELLOW NO. 5
SODIUM HYDROXIDE
AQUA
SORBITOL
SILICON DIOXIDE
XYLITOL
SUCRALOSE
XANTHAN GUM
METHYL SALICYLATE
GLYCERIN
SODIUM BENZOATE
POLOXAMER 407
CARBOMER
FD&C BLUE NO. 1

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
51206-314	51206-314-01, 51206-314-03, 51206-314-02, 51206-314-04, 51206-314-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SODIUM FLUORIDE	8ZYQ1474W7	ACTIM
SODIUM LAURYL SULFATE	368GB5141J	IACT
FD&C YELLOW NO. 5	I753WB2F1M	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
AQUA	059QF0KO0R	IACT
SORBITOL	506T60A25R	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
XYLITOL	VCQ006KQ1E	IACT
SUCRALOSE	96K6UQ3ZD4	IACT
XANTHAN GUM	TTV12P4NEE	IACT
METHYL SALICYLATE	LAV5U5022Y	IACT
GLYCERIN	PDC6A3C0OX	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
POLOXAMER 407	TUF2IVW3M2	IACT
CARBOMER	0A5MM307FC	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
3	2026-04-06	full-release	2026-06-01 01:52:44
2	2026-03-26	monthly-update	2026-06-03 17:59:02
1	2025-12-01	monthly-update	2026-06-03 17:45:36

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 Cool Mint	SODIUM FLUORIDE	Ultradent Products, Inc.	44e7d0ed-3c37-5889-e063-6294a90afcca	2026-09-09	Warnings	Exact identifier ndc (package): 51206-314-03 ndc (package): 51206-314-04 ndc (package): 51206-314-01 ndc (package): 51206-314-05 ndc (package): 51206-314-02 ndc (product): 51206-314 ndc11 (package): 51206031401 ndc11 (package): 51206031403 ndc11 (package): 51206031404 ndc11 (package): 51206031405 ndc11 (package): 51206031402 spl id: 5b14bdd2-2852-1c00-e063-6294a90ac4cc spl set id: 44e7d0ed-3c37-5889-e063-6294a90afcca

Reported adverse events (FAERS/openFDA)#

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