FDA.reportPublic FDA data

Opal by Opalescence Complete - Ultradent Products, Inc.

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 01:01:25

Label at a glance#

ProductOpal by Opalescence Complete
Active ingredientSTANNOUS FLUORIDE
Label structure2 sections

Label contents#

Full prescribing information#

WARNINGS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TubeTube

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData Matrix1011941AR011011941AR01-Opal-Toothpaste_Tube-Stannous-0224-01.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

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
51206-31351206-313-01, 51206-313-02

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
ZINC CITRATEK72I3DEX9BIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
SODIUM HYDROXIDE55X04QC32IIACT
SODIUM LAURYL SULFATE368GB5141JIACT
WATER059QF0KO0RIACT
XYLITOLVCQ006KQ1EIACT
POLOXAMER 407TUF2IVW3M2IACT
SODIUM PYROPHOSPHATEO352864B8ZIACT
SODIUM BENZOATEOJ245FE5EUIACT
XANTHAN GUMTTV12P4NEEIACT
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)HHT01ZNK31IACT
GLYCERINPDC6A3C0OXIACT
SUCRALOSE96K6UQ3ZD4IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
FD&C YELLOW NO. 5I753WB2F1MIACT
SORBITOL506T60A25RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32025-06-17full-release2026-06-01 01:03:17

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Opal by Opalescence CompleteOPAL BY OPALESCENCE COMPLETEUltradent Products, Inc.249cc46a-dad6-0345-e063-6394a90a44472026-09-09WarningsExact identifier
ndc (package): 51206-313-01
ndc (package): 51206-313-02
ndc (product): 51206-313
ndc11 (package): 51206031302
ndc11 (package): 51206031301
spl id: 5b14f120-efa2-668b-e063-6294a90ab0fc
spl set id: 249cc46a-dad6-0345-e063-6394a90a4447

Reported adverse events (FAERS/openFDA)#

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