FDA.reportPublic FDA data

Opalescence Whitening

Product NDC
51206-302
11-digit product format
512060302
Labeler code
51206
Product ID
51206-302_5b14d90f-23ec-372b-e063-6294a90a2066
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
1994-07-01
Marketing end
2030-09-30
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
Opalescence Whitening

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
d07f842e-b6f1-4ae1-b576-f542ecd02dd4Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
51206-302-06Opalescence™ whitening toothpaste
51206-302-06Opalescence™ whitening toothpaste
51206-302-07Opalescence™ whitening toothpaste
51206-302-07Opalescence™ whitening toothpaste
51206-302-08Opalescence™ whitening toothpaste
51206-302-08Opalescence™ whitening toothpaste
51206-302-09Opalescence™ whitening toothpaste
51206-302-09Opalescence™ whitening toothpaste
51206-302-10Opalescence™ whitening toothpaste
51206-302-10Opalescence™ whitening toothpaste
51206-302-11Opalescence™ whitening toothpaste
51206-302-11Opalescence™ whitening toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51206-302-06Opalescence Whitening133 g in 1 TUBEGEL, DENTIFRICE1339
51206-302-06Opalescence Whitening1 in 1 BOXGEL, DENTIFRICE19
51206-302-07Opalescence Whitening1 in 1 BOXGEL, DENTIFRICE19
51206-302-07Opalescence Whitening28.35 g in 1 TUBEGEL, DENTIFRICE28.359
51206-302-08Opalescence Whitening1 in 1 BOXGEL, DENTIFRICE19
51206-302-08Opalescence Whitening3 in 1 PACKAGE, COMBINATIONGEL, DENTIFRICE39
51206-302-09Opalescence Whitening1 in 1 BOXGEL, DENTIFRICE19
51206-302-09Opalescence Whitening12 in 1 PACKAGE, COMBINATIONGEL, DENTIFRICE129
51206-302-10Opalescence Whitening24 in 1 PACKAGE, COMBINATIONGEL, DENTIFRICE249
51206-302-10Opalescence Whitening1 in 1 BOXGEL, DENTIFRICE19
51206-302-11Opalescence Whitening1 in 1 BOXGEL, DENTIFRICE19
51206-302-11Opalescence Whitening6 in 1 PACKAGE, COMBINATIONGEL, DENTIFRICE69

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Sodium FluorideACTIVE INGREDIENT8ZYQ1474W7OPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]1
Fluoride IonACTIVE MOIETYQ80VPU408OOPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]1
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDOPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]1
FD&C Yellow No. 5INACTIVE INGREDIENTI753WB2F1MOPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXOPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]1
Methyl SalicylateINACTIVE INGREDIENTLAV5U5022YOPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]1
Saccharin SodiumINACTIVE INGREDIENTSB8ZUX40TYOPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]1
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4OPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]1
Sodium BenzoateINACTIVE INGREDIENTOJ245FE5EUOPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]1
Sodium Lauryl SulfateINACTIVE INGREDIENT368GB5141JOPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]1
SorbitolINACTIVE INGREDIENT506T60A25ROPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0ROPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]1
Xanthan GumINACTIVE INGREDIENTTTV12P4NEEOPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]1
XylitolINACTIVE INGREDIENTVCQ006KQ1EOPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51206-302OPALESCENCE WHITENING (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC]7Current NDC, Legacy NDC, 12 package rows20240224_d07f842e-b6f1-4ae1-b576-f542ecd02dd4.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 27 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest plus Tartar Protection WhiteningSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company08776dfc-b07a-3729-e063-6394a90aeeed2026-01-08WarningsExact identifier
application number: M021
Crest Plus Active Fresh plus Whitening ScopeSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company17f3b749-01ea-2561-e063-6294a90a5d3b2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Advanced Deep CleanSODIUM FLUORIDEProcter & Gamble Manfuacturing Company128613c4-c06b-bdf5-e063-6294a90acd342026-01-08WarningsExact identifier
application number: M021
Crest 3D White Brilliance Pro RinseSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company13a01190-a6f3-17b3-e063-6294a90a36c22026-01-08WarningsExact identifier
application number: M021
HEB HEBuddyFLUORIDEHEB2c972c65-34aa-4348-b997-c5e65a8845752026-01-08WarningsExact identifier
application number: M021
ARC 2 in 1 Whitening and AnticavitySODIUM MONOFLUOROPHOSPHATEThe Procter & Gamble Manufacturing Company12634efa-35e3-76d7-e063-6294a90a3de42026-01-08Exact identifier
application number: M021
Crest Plus Whitening Deep CleanSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company15482445-39f3-7e02-e063-6294a90ad1dc2026-01-08WarningsExact identifier
application number: M021
H E B Restore and DefendFLUORIDEHEB56080493-9ab8-4b4f-be5f-7df22dee133f2026-01-08WarningsExact identifier
application number: M021
Crest Plus Cinnamon Expressions plus WhiteningSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company151d2a0a-448f-7744-e063-6294a90acd3b2026-01-08WarningsExact identifier
application number: M021
Oral B Mouth Sore Special Care RinseHYDROGEN PEROXIDEThe Procter & Gamble Manufacturing Company22e2dc15-5794-28ed-e063-6394a90a36d32026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Advanced Anti-Cavity Max CavitySODIUM FLUORIDEThe Procter & Gamble Manufacturing Company15d70b80-3b25-bc32-e063-6394a90a163e2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Brilliance Bright MintSODIUM FLUORIDEProcter & Gamble Manfuacturing Company1dee0584-0fed-61c6-e063-6394a90adbcd2026-01-08WarningsExact identifier
application number: M021
HEB Gleaming White Arctic MintSODIUM FLUORIDEHEB8248eddb-20a5-7084-e053-2991aa0a16b52026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Gum Rescue Pro Soothing CleanSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company2f10c7ac-eb60-011e-e063-6394a90aca132026-01-08WarningsExact identifier
application number: M021
Crest Deep Cleanse Cavity DefenseSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company2e09cb3b-cf59-15b1-e063-6394a90a5c6a2026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Maximum Cavity ProtectionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company2eaeddc5-1559-9378-e063-6394a90a4ed72026-01-08WarningsExact identifier
application number: M021
Crest 3D White Deep Stain Remover Dazzling MintSODIUM MONOFLUOROPHOSPHATEThe Procter & Gamble Manufacturing Company2f11e935-1711-5f1a-e063-6294a90af7d82026-01-08Exact identifier
application number: M021
HEB Gleaming White Fresh MintSODIUM FLUORIDEHEB82491c8f-d2c2-2e4a-e053-2a91aa0a572f2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Brilliance Pro Ultra WhiteSODIUM MONOFLUOROPHOSPHATEThe Procter & Gamble Manufacturing Company338acdf2-548c-0614-e063-6294a90af6352026-01-08Exact identifier
application number: M021
KIDS Crest Advanced Sugar and Bacteria ShieldSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company2f371af0-a2d4-25a6-e063-6394a90a923d2026-01-08WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1044547sodium fluoride 0.25 % ToothpastePSNd07f842e-b6f1-4ae1-b576-f542ecd02dd49
1044547sodium fluoride 0.0025 MG/MG ToothpasteSCDd07f842e-b6f1-4ae1-b576-f542ecd02dd49
1044547sodium fluoride 0.25 % (fluoride ion 0.15 % ) ToothpasteSYd07f842e-b6f1-4ae1-b576-f542ecd02dd49
1044547sodium fluoride 0.25 % ToothpasteSYd07f842e-b6f1-4ae1-b576-f542ecd02dd49

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51206-302-06512060302061 TUBE in 1 BOX (51206-302-06) / 133 g in 1 TUBE1 tube1994-07-012030-09-30NoNoCurrent
51206-302-07512060302071 TUBE in 1 BOX (51206-302-07) / 28.35 g in 1 TUBE1 tube1994-07-012030-09-30NoNoCurrent
51206-302-08512060302083 BOX in 1 PACKAGE, COMBINATION (51206-302-08) / 1 TUBE in 1 BOX / 133 g in 1 TUBE3 box2016-06-012030-09-30NoNoCurrent
51206-302-095120603020912 BOX in 1 PACKAGE, COMBINATION (51206-302-09) / 1 TUBE in 1 BOX / 133 g in 1 TUBE12 box2016-06-012030-09-30NoNoCurrent
51206-302-105120603021024 BOX in 1 PACKAGE, COMBINATION (51206-302-10) / 1 TUBE in 1 BOX / 28.35 g in 1 TUBE24 box2016-06-012030-09-03NoNoCurrent
51206-302-11512060302116 BOX in 1 PACKAGE, COMBINATION (51206-302-11) / 1 TUBE in 1 BOX / 133 g in 1 TUBE6 box2020-08-242030-09-30NoNoCurrent