FDA.reportPublic FDA data

ADVANCED WHITENING ANTI CAVITY FLUORIDE

Product NDC
52000-108
11-digit product format
520000108
Labeler code
52000
Product ID
52000-108_ede5654c-864e-44c6-904b-ca2ac4532096
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Monofluorophosphate
Dosage form
PASTE
Route
DENTAL
Labeler
Universal Distribution Center LLC
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-05-18
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
.76 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
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
ADVANCED WHITENING ANTI CAVITY FLUORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM MONOFLUOROPHOSPHATE.76 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
C810JCZ56QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
545626Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ea8a8d9-b7e4-468f-9a09-4ec634cbd80eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52000-108-01ADVANCED WHITENING ANTI CAVITY FLUORIDE181 g in 1 TUBEPASTE1812

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52000-108ADVANCED WHITENING ANTI CAVITY FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE [UNIVERSAL DISTRIBUTION CENTER LLC]2Current NDC, Legacy NDC, 1 package rows20231121_8ea8a8d9-b7e4-468f-9a09-4ec634cbd80e.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 37 of 49 · 974 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dentalclean Green Diamond Alcohol Free MouthwashSODIUM FLUORIDE 0.05%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda5653aa33-4f0e-46b2-9be0-6219143556ec2025-07-14WarningsExact identifier
application number: M021
Colgate Total Gum Protect Fresh MintSTANNOUS FLUORIDECOLGATE PALMOLIVE COMPANY570e3bd6-eede-4270-9d78-055aeb2b8c172025-07-14WarningsExact identifier
application number: M021
OraPro Fluoride AnticavityFLUORIDE TOOTHPASTEProtegera, Inc.93b0181c-e29f-42f4-80f5-366463b68f092025-07-10WarningsExact identifier
application number: M021
Enamur Fluoride AntiCavity ToothpastFLUORIDE TOOTHPASTProtegera, Inc557ced45-f54e-43d8-aa13-46f75b79367c2025-07-10WarningsExact identifier
application number: M021
Super StrawberrySTRAWBERRY TOOTHPASTESuperMouth, LLC.a8c2b68d-d28b-41c0-a383-cc706b25aa1a2025-07-05WarningsExact identifier
application number: M021
Super MintSUPER MINT TOOTHPASTESuperMouth, LLC.be0915f3-36c4-4200-9d15-704cfbd632b42025-07-05WarningsExact identifier
application number: M021
Super VanillaVANILLA TOOTHPASTESuperMouth, LLC.3ddfe20a-86f1-4566-bb77-82c9749411f62025-07-05WarningsExact identifier
application number: M021
Super ChocolateCHOCOLATE TOOTHPASTESuperMouth, LLC.48607622-7c5e-4ddc-8d83-707f26c0553f2025-07-05WarningsExact identifier
application number: M021
CURODONT REPAIR FLUORIDE PLUSSODIUM FLUORIDECREDENTIS AG290c57b0-a562-0a51-e063-6294a90a07202025-06-23WarningsExact identifier
application number: M021
KarlnHans Fresh Breath Jasmine MintSODIUM MONOFLUOROPHOSPHATEPIGEON CORPORATION384863bd-b2cb-a46d-e063-6394a90a3ce22025-06-23WarningsExact identifier
application number: M021
KarlnHans Fresh Breath Double MintSODIUM MONOFLUOROPHOSPHATEPIGEON CORPORATION38487130-9508-a2c4-e063-6394a90aa3232025-06-23WarningsExact identifier
application number: M021
Crest Kids SparkleFun BubblegumSODIUM FLUORIDEProcter & Gamble Manufactura, S. de R.L. de C.V.01f0e81a-03bf-e17f-e063-6394a90a73582025-06-12WarningsExact identifier
application number: M021
Freshen UpSODIUM FLUORIDE, POTASSIUM NITRATEMKJ BRANDS LLC2ee626d1-6150-87db-e063-6294a90a64d82025-06-12WarningsExact identifier
application number: M021
Colgate MaxFresh Citrus FreshSODIUM FLUORIDEColgate-Palmolive Company13a74642-51d2-493c-ae97-a54508546a742025-06-12WarningsExact identifier
application number: M021
Colgate MaxFresh Watermelon BlastSODIUM FLUORIDEColgate-Palmolive Company4f07f945-6594-40f4-bc19-6acc12c37cdd2025-06-12WarningsExact identifier
application number: M021
Euthymol WhiteningSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.36994628-e5f3-3c35-e063-6294a90a609d2025-06-02WarningsExact identifier
application number: M021
EUTHYMOL WHITENING SPECIAL GIFT SETSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.35bfa3fc-106e-aecc-e063-6294a90a7eb02025-05-22WarningsExact identifier
application number: M021
EUTHYMOL WHITENING GIFT SET (40gX3)SODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.369aa02f-c312-6a0d-e063-6294a90adaa52025-05-22WarningsExact identifier
application number: M021
EUTHYMOL WHITENING TRAVELSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.3596306e-858c-9bf7-e063-6294a90ac1d62025-05-20WarningsExact identifier
application number: M021
Euthymol WhiteningSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.3582cc91-8c32-9f93-e063-6394a90a87922025-05-19WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN8ea8a8d9-b7e4-468f-9a09-4ec634cbd80e2
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD8ea8a8d9-b7e4-468f-9a09-4ec634cbd80e2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY8ea8a8d9-b7e4-468f-9a09-4ec634cbd80e2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY8ea8a8d9-b7e4-468f-9a09-4ec634cbd80e2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY8ea8a8d9-b7e4-468f-9a09-4ec634cbd80e2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY8ea8a8d9-b7e4-468f-9a09-4ec634cbd80e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52000-108-0152000010801181 g in 1 TUBE (52000-108-01) 181 g2020-05-180000-00-00NoNoCurrent