FDA.reportPublic FDA data

Opalescence Complete Whitening Toothpaste

Manufacturer
Ultradent Products, Inc.
Effective date
2026-10-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-10-13 04:05:28

Label at a glance#

ProductOpalescence Whitening Complete
Active ingredientSTANNOUS FLUORIDE
Label structure11 sections

Indications and uses

Aids in the prevention of dental decay Helps prevent gingivitis Protects against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact Helps interfere with the harmful effects of plaque associated with gingivitis

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 This product may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Stannous Fluoride 0.454% w/w

(0.15% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity,

Antigingivitis,

Antisensitivity

Uses

INDICATIONS & USAGE SECTION

  • Aids in the prevention of dental decay
  • Helps prevent gingivitis
  • Protects against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact
  • Helps interfere with the harmful effects of plaque associated with gingivitis

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age.

Warnings

WARNINGS SECTION

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
  • This product may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua, Silica, Glycerin, Sorbitol, Xylitol, Flavor (Aroma), Poloxamer 407, Sodium Lauryl Sulfate, Sodium Hydroxide, Tetrasodium Pyrophosphate, Zinc Citrate, Carbomer, CI 19140< CI 42090, Sodium Benzoate, Sucralose, Xanthan Gum

Questions or comments

OTC - QUESTIONS SECTION

Call toll-free 800.552.5512

Principle Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCartonOpalescence Whitening Toothpaste Complete

Brilliant Mint

Stannous Fluoride Toothpaste

NET WT. 4.7 oz * 133 g

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codeqr-codes.io/5RPXaw1013241AR02-Opalescence Complete_Carton.jpg
Data codeData Matrix1013241AR021013241AR02-Opalescence Complete_Carton.jpg

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51206-45251206-452-01, 51206-452-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
STANNOUS FLUORIDE3FTR44B32QACTIM
FLAVOR SPICE MINT N&A110589KG6KU384XWIACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT
POLOXAMER 407TUF2IVW3M2IACT
SODIUM BENZOATEOJ245FE5EUIACT
GLYCERINPDC6A3C0OXIACT
XYLITOLVCQ006KQ1EIACT
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)HHT01ZNK31IACT
SORBITOL506T60A25RIACT
SUCRALOSE96K6UQ3ZD4IACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM PYROPHOSPHATEO352864B8ZIACT
XANTHAN GUMTTV12P4NEEIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
ZINC CITRATEK72I3DEX9BIACT

Source Document#

Source XML

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 8 · 148 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Therabreath Deep CleanSTANNOUS FLUORIDEChurch & Dwight Co., Inc.3c372f26-e0c4-0659-e063-6294a90ae9f92026-08-21WarningsName fallback
generic name: STANNOUS FLUORIDE
COLGATE TOTAL ACTIVE PREVENTION CLEAN MINTSTANNOUS FLUORIDEColgate-Palmolive Company178d4535-fa57-4b53-b1f8-5c591f2ea9e72026-08-21WarningsName fallback
generic name: STANNOUS FLUORIDE
Colgate Sensitive ProRelief WhiteningSTANNOUS FLUORIDEColgate-Palmolive Company8d9d485e-6efb-4bca-a779-9e8b0aeed14c2026-08-18WarningsName fallback
generic name: STANNOUS FLUORIDE
Colgate Total SF WhiteningSTANNOUS FLUORIDECOLGATE PALMOLIVE COMPANY7f6b6aa8-50da-151b-c448-9e427d37398f2026-06-11WarningsName fallback
generic name: STANNOUS FLUORIDE
Colgate Total Sensitivity Mineral ShieldSTANNOUS FLUORIDEColgate-Palmolive Companyf065318c-1e2a-c04d-f254-f8127b05a88f2026-06-10WarningsName fallback
generic name: STANNOUS FLUORIDE
Colgate Total SF Fresh Mint StripeSTANNOUS FLUORIDECOLGATE PALMOLIVE COMPANY657020c7-e85c-4c61-9f62-b50351e4b4e52026-06-10WarningsName fallback
generic name: STANNOUS FLUORIDE
Walgreens Restore and DefendSTANNOUS FLUORIDEWalgreense808ea4b-9081-085b-e053-2a95a90a4f9b2026-06-02WarningsName fallback
generic name: STANNOUS FLUORIDE
Gum Health DetoxifySTANNOUS FLUORIDEMeijer, Inc41d70733-a223-40fb-e063-6294a90a13972026-05-06WarningsName fallback
generic name: STANNOUS FLUORIDE
Equate Pro-Advanced TP Equate Pro-Advanced TPSTANNOUS FLUORIDEWalmart Inc.1e6561fb-4e3b-40ba-e063-6294a90a26902026-04-29WarningsName fallback
generic name: STANNOUS FLUORIDE
Colgate Total SF WhiteningSTANNOUS FLUORIDEColgate-Palmolive Company3bba340e-2a62-3b04-41b5-0ed9c13adb132026-04-22WarningsName fallback
generic name: STANNOUS FLUORIDE
Gum DetoxifySTANNOUS FLUORIDEWalmart41d6cc7a-0b87-e474-e063-6294a90ae9952026-04-20WarningsName fallback
generic name: STANNOUS FLUORIDE
Crest Pro-Health Advanced Bacteria ProtectionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company4f1ce508-fe6e-4045-e063-6294a90ab3e22026-04-10WarningsName fallback
generic name: STANNOUS FLUORIDE
Crest Clean Breath PeppermintSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company4f1ef07b-ee68-e6ae-e063-6394a90af5e52026-04-10WarningsName fallback
generic name: STANNOUS FLUORIDE
Crest Clean Breath SpearmintSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company4f20343e-6c03-48e8-e063-6294a90a8cdf2026-04-10WarningsName fallback
generic name: STANNOUS FLUORIDE
Crest Clean Breath Smooth MintSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company4f2042b4-8eae-5c2c-e063-6394a90a640c2026-04-10WarningsName fallback
generic name: STANNOUS FLUORIDE
Crest Clean Breath SpearmintSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company4e544d09-0cf3-f0c7-e063-6394a90a23692026-03-31WarningsName fallback
generic name: STANNOUS FLUORIDE
Colgate Total Enamel StrengthSTANNOUS FLUORIDEColgate-Palmolive Company1f29c893-e7c5-4a0e-941b-c2634d8211472026-03-25WarningsName fallback
generic name: STANNOUS FLUORIDE
LIVFRESH GUM PROTECTSTANNOUS FLUORIDELivionex Inc.1da7dcf9-e675-4b4b-8286-bdaa6e59eb0f2026-02-02WarningsName fallback
generic name: STANNOUS FLUORIDE
ARU GUM HEALTHSTANNOUS FLUORIDEAshtel Studios, Inc.d8e8b92e-d8cb-45ad-8353-7dbe43c3dcd32026-01-30WarningsName fallback
generic name: STANNOUS FLUORIDE
Crest Pro-Health Advanced Max Cavity and Erosion PreventionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company48eb0bdc-7399-745d-e063-6294a90a98092026-01-21WarningsName fallback
generic name: STANNOUS FLUORIDE

Reported adverse events (FAERS/openFDA)#

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