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 42 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EUTHYMOL Extraordinary Pink WhiteningSODIUM FLUORIDETai Guk Pharm. Co., Ltd.05a9cee1-bd6e-6b93-e063-6294a90a5c102025-01-01WarningsExact identifier
application number: M021
PERIOE POP Advanced Whitening Prebiotic Cool MintSODIUM FLUORIDETai Guk Pharm. Co., Ltd.f546470a-7fae-4988-e053-2995a90ab61b2025-01-01WarningsExact identifier
application number: M021
PERIOE Microbiome Whitening Cool MintSODIUM FLUORIDETai Guk Pharm. Co., Ltd.de97dbea-dc8c-ebfa-e053-2995a90a22702025-01-01WarningsExact identifier
application number: M021
POP Gel Pumpin StrawberrySODIUM FLUORIDETai Guk Pharm. Co., Ltd.05b1020b-a1c3-e1eb-e063-6394a90ac2662025-01-01WarningsExact identifier
application number: M021
PERIOE POP Complete Protection Prebiotic Mint BlastSODIUM FLUORIDETai Guk Pharm. Co., Ltd.f547a468-d2fd-7176-e053-2995a90a55392025-01-01WarningsExact identifier
application number: M021
PERIOE Whitening Essentials 10X Charcoal Black Clean MintSODIUM FLUORIDETai Guk Pharm. Co., Ltd.b4530d56-3a17-6868-e053-2995a90a25242025-01-01WarningsExact identifier
application number: M021
PERIOE Microbiome Total Care Strong MintSODIUM FLUORIDETai Guk Pharm. Co., Ltd.de996aeb-9ac0-836f-e053-2a95a90aeda62025-01-01WarningsExact identifier
application number: M021
POP Hint Of MintSODIUM FLUORIDETai Guk Pharm. Co., Ltd.05aafc53-49ca-eacd-e063-6394a90a606b2025-01-01WarningsExact identifier
application number: M021
POP Gel Whatzzup WatermelonSODIUM FLUORIDETai Guk Pharm. Co., Ltd.05b18bb6-9fbf-469b-e063-6294a90a4f2f2025-01-01WarningsExact identifier
application number: M021
AVON Whitening Essentials 10X Charcoal Black Clean MintSODIUM FLUORIDETai Guk Pharm. Co., Ltd.9c820740-9148-3a9c-e053-2a95a90a39682025-01-01WarningsExact identifier
application number: M021
PERIOE Whitening Essentials Fresh Aloe Green MintSODIUM FLUORIDETai Guk Pharm. Co., Ltd.a3b21ceb-5aa5-29b4-e053-2a95a90a95452025-01-01WarningsExact identifier
application number: M021
POP Gel Pumpin StrawberrySODIUM FLUORIDELG H&H Co., Ltd.05b25897-460c-2dfb-e063-6294a90ada3b2025-01-01WarningsExact identifier
application number: M021
EUTHYMOL Extraordinary Pink WhiteningSODIUM FLUORIDELG H&H Co., Ltd.05b1f105-6f75-7a45-e063-6394a90a58bc2025-01-01WarningsExact identifier
application number: M021
POP Hint Of MintSODIUM FLUORIDELG H&H Co., Ltd.05b25083-12f3-7a85-e063-6394a90a492e2025-01-01WarningsExact identifier
application number: M021
POP Gel Whatzzup WatermelonSODIUM FLUORIDELG H&H Co., Ltd.05b276a1-3778-104d-e063-6294a90a75372025-01-01WarningsExact identifier
application number: M021
kids kareSTANNOUS FLUORIDEDEN-MAT HOLDINGS, LLC.66d7ae1f-ff7a-7fe4-e053-2991aa0a9f912024-12-31WarningsExact identifier
application number: M021
Kids KareSODIUM FLUORIDEDEN-MAT HOLDINGS, LLC.66d6b20f-d0ff-4dfe-e053-2991aa0a99ca2024-12-31WarningsExact identifier
application number: M021
Morning FreshSODIUM FLUORIDEDynarex Corporation1d0457d7-0228-4ea3-9755-73bacd2201e62024-12-27WarningsExact identifier
application number: M021
Bubble Fresh Toothpaste, with FluorideBUBBLE FRESH TOOTHPASTE, WITH FLUORIDEDynarex Corporation2a2f5ed9-31ec-f6c8-e063-6394a90a44d62024-12-26WarningsExact identifier
application number: M021
Brush Buddies Crayola Swirl ANTICAVITY FLUORIDE WATERMELON FLAVORSODIUM FLUORIDEAshtel Studios, Inc.b3006c29-1f7f-4d9f-ab46-5a36df1a04712024-12-25WarningsExact 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