warnings
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.
Opal by Opalescence Complete
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- Brand name
- Opal by Opalescence Complete
- Generic name
- OPAL BY OPALESCENCE COMPLETE
- Manufacturer
- Ultradent Products, Inc.
- Product type
- HUMAN OTC DRUG
- SPL set ID
- 249cc46a-dad6-0345-e063-6394a90a4447
- SPL ID
- 5b14f120-efa2-668b-e063-6294a90ab0fc
- Version
- 4
- Effective date
- 2026-09-09
- Source export date
- 2026-09-28
- Source partition
- 8
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:56:26
| Harmonized routes |
|---|
| DENTAL |
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application number | M021 | openfda.application_number | |
| brand name | Opal by Opalescence Complete | openfda.brand_name | |
| generic name | OPAL BY OPALESCENCE COMPLETE | openfda.generic_name | |
| manufacturer name | Ultradent Products, Inc. | openfda.manufacturer_name | |
| ndc | package | 51206-313-01 | openfda.package_ndc |
| ndc | package | 51206-313-02 | openfda.package_ndc |
| ndc | product | 51206-313 | openfda.product_ndc |
| ndc11 | package | 51206031302 | derived:openfda.package_ndc |
| ndc11 | package | 51206031301 | derived:openfda.package_ndc |
| rxcui | 416784 | openfda.rxcui | |
| spl id | 5b14f120-efa2-668b-e063-6294a90ab0fc | id | |
| spl set id | 249cc46a-dad6-0345-e063-6394a90a4447 | set_id | |
| unii | 3FTR44B32Q | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.