FDA.reportPublic FDA data

Opal by Opalescence Original

Product NDC
51206-312
11-digit product format
512060312
Labeler code
51206
Product ID
51206-312_5b14e96f-d015-5738-e063-6294a90ac014
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
GEL, DENTIFRICE
Route
DENTAL
Labeler
Ultradent Products, Inc.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-11-19
Marketing end
2029-02-21
Substance
SODIUM FLUORIDE
Active strength
1.1 mg/g
NDC exclude flag
No
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Opal by Opalescence Original

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE1.1 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1044547Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5c3bf8fc-2e8f-4a58-bcbf-e47540072a49Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51206-312-022024-01-30C16284748780-11030e365-4aaa-111a-e063-dadaa90a10e2Opal™ by Opalescence ® Original
51206-312-022024-01-30C16284748780-11030e365-4aaa-111a-e063-dadaa90a10e2Opal™ by Opalescence ® Original

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51206-312-01Opal by Opalescence Original1 in 1 CARTONGEL, DENTIFRICE15
51206-312-01Opal by Opalescence Original133 g in 1 TUBEGEL, DENTIFRICE1335
51206-312-02Opal by Opalescence Original1 in 1 CARTONGEL, DENTIFRICE15
51206-312-02Opal by Opalescence Original3 in 1 PACKAGE, COMBINATIONGEL, DENTIFRICE35

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51206-312OPAL BY OPALESCENCE ORIGINAL (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]4Current NDC, 4 package rows20250402_5c3bf8fc-2e8f-4a58-bcbf-e47540072a49.zip

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 25 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest Pro Health Advanced Enamel RestoreSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd813f5f0-3135-4a8f-e053-2a95a90a55622026-01-08WarningsExact identifier
application number: M021
Crest 3D White BrillianceSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company8e189fbd-5094-4398-b96c-8f95d89b9cdd2026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Densify RinseSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyd84fb9f9-f2bc-358a-e053-2995a90abf072026-01-08WarningsExact identifier
application number: M021
Kids Crest Strawberry RushSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyeb7a5698-754c-4e46-e053-2a95a90a57b42026-01-08WarningsExact identifier
application number: M021
Crest 3D White Brilliance Daily Cleansing and Whitening SystemSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company89a6fb36-5109-47f1-95ad-9381471ceeef2026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Advanced w/Extra WhiteningSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company2c1c5563-0b7e-4c7c-b49f-3d72e078cd282026-01-08WarningsExact identifier
application number: M021
Crest 3D White Stain Eraser Fresh MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyc81ba39d-c7ea-b2a5-e053-2995a90a0fe72026-01-08Exact identifier
application number: M021
Crest Premium Plus Breath Bacteria BlastSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyc3f1d477-6dd8-0ac4-e053-2a95a90a37422026-01-08WarningsExact identifier
application number: M021
Crest Premium Plus Active Foam Whitening scopeSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyc72b15e0-e69c-65fc-e053-2a95a90a54c82026-01-08WarningsExact identifier
application number: M021
Crest Complete Plus Scope Outlast UltraSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyc3f63455-b09e-9877-e053-2a95a90a18442026-01-08WarningsExact identifier
application number: M021
Crest Tartar Protection Fresh Mint GelSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company3d81d605-4f9b-3bb5-e054-00144ff88e882026-01-08WarningsExact identifier
application number: M021
Crest Complete plus WhiteningSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companye3b1f139-4fe8-f005-e053-2995a90a53b42026-01-08WarningsExact identifier
application number: M021
Crest 3D White Radiant MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf3dd7a34-a0d8-4ac6-bbd1-7c3b86187a572026-01-08WarningsExact identifier
application number: M021
Crest Complete Plus Active Fresh plus Whitening ScopeSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyc599d33f-788f-7fdd-e053-2a95a90a5f572026-01-08WarningsExact identifier
application number: M021
Crest Complete Multi Benefit Whitening plus Scope OutlastSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company66c41b24-d394-6609-e053-2a91aa0a0a2c2026-01-08WarningsExact identifier
application number: M021
Crest Complete Plus 3 in 1SODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyb6fab2eb-da5c-749f-e053-2995a90a13572026-01-08WarningsExact identifier
application number: M021
Crest Tartar ProtectionSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company85477763-1db5-482f-90e5-e71f5c1b47652026-01-08WarningsExact identifier
application number: M021
Crest Fresh and WhiteSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf9b31f6b-6b3f-abe0-e053-6294a90acb252026-01-08WarningsExact identifier
application number: M021
Crest Complete plus Whitening Deep CleanSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyc367c2cc-5e0f-bc4e-e053-2995a90a2e2c2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Glamorous WhiteSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyc3f29f95-81b9-3989-e053-2a95a90af3a62026-01-08WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1044547sodium fluoride 0.25 % ToothpastePSN5c3bf8fc-2e8f-4a58-bcbf-e47540072a495
1044547sodium fluoride 0.0025 MG/MG ToothpasteSCD5c3bf8fc-2e8f-4a58-bcbf-e47540072a495
1044547sodium fluoride 0.25 % (fluoride ion 0.15 % ) ToothpasteSY5c3bf8fc-2e8f-4a58-bcbf-e47540072a495
1044547sodium fluoride 0.25 % ToothpasteSY5c3bf8fc-2e8f-4a58-bcbf-e47540072a495

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51206-312-01512060312011 TUBE in 1 CARTON (51206-312-01) / 133 g in 1 TUBE1 tube2023-11-192029-02-21NoNoHistorical
51206-312-02512060312023 CARTON in 1 PACKAGE, COMBINATION (51206-312-02) / 1 TUBE in 1 CARTON / 133 g in 1 TUBE3 carton2023-11-192029-02-21NoNoHistorical