FDA.reportPublic FDA data

UNIVERSAL ADVANCED WHITENING ANTI-CAVITY FLUORIDE

Product NDC
52000-112
11-digit product format
520000112
Labeler code
52000
Product ID
52000-112_e3086345-3da8-4262-9854-15ab1e031e58
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
2020-05-30
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
UNIVERSAL 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
879dfaf0-27c8-41a3-8d01-a1c3eec9edfcAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52000-112-01UNIVERSAL ADVANCED WHITENING ANTI-CAVITY FLUORIDE181 g in 1 TUBEPASTE1812

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52000-112UNIVERSAL ADVANCED WHITENING ANTI-CAVITY FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE [UNIVERSAL DISTRIBUTION CENTER LLC]2Current NDC, Legacy NDC, 1 package rows20231121_879dfaf0-27c8-41a3-8d01-a1c3eec9edfc.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 50 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
United Airlines Therabody Polaris KitSODIUM MONOFLUOROPHOSPHATEWessco Internationalab667740-55ab-470e-9514-163961502ceb2023-10-26WarningsExact identifier
application number: M021
Cavity Protection Fresh MintSODIUM FLUORIDEOxyfresh Worldwide Inc0ae98f28-7e78-4379-93b0-4f2657415c4d2023-10-25WarningsExact identifier
application number: M021
Tanners Tasty Vanilla BlingSODIUM FLUORIDESheffield Pharmaceuticals LLC521fe01e-7f2e-4d79-9126-e4880cdf4e712023-10-24WarningsExact identifier
application number: M021
Tanners Tasty Ooh La La OrangeSODIUM FLUORIDESheffield Pharmaceuticals LLC6027b961-314e-4f71-8b2f-646ce80214d82023-10-24WarningsExact identifier
application number: M021
Tanners Tasty Cha Cha ChocolateSODIUM FLUORIDESheffield Pharmaceuticals LLC8609dbf3-7620-4a13-b40b-6bd705a78fb02023-10-24WarningsExact identifier
application number: M021
Glister Multi-ActionSODIUM FLUORIDEAccess Business Group LLCe3f2c049-a0f5-4649-a4aa-11bdb252f9512023-10-23WarningsExact identifier
application number: M021
UNITED Asutra TC Kit ColgateSODIUM MONOFLUOROPHOSPHATEMING FAI ENTERPRISE (CAMBODIA) CO., LTD082a581a-c7e5-e614-e063-6394a90a87da2023-10-20WarningsExact identifier
application number: M021
Plak Smacker Anti Cavity FluorideSODIUM FLUORIDEYOUNG PS ACQUISITION, LLCc6dee5fa-9cd4-4a94-9cbe-e977b2bd3dfe2023-10-16WarningsExact identifier
application number: M021
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.152d84ee-d981-4032-bfb1-a559afe71d402023-10-11WarningsExact identifier
application number: M021
Sodium FluorideSODIUM FLUORIDESafco Dental Supply LLC788080b3-fff8-4049-af98-f571824994c22023-10-11WarningsExact identifier
application number: M021
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.5c312b36-07f4-406e-b3d3-c6d1e964635d2023-10-11WarningsExact identifier
application number: M021
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.042636cf-8b61-4022-b0a1-af09c06b145b2023-10-11WarningsExact identifier
application number: M021
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.f4c3569b-7b6a-4566-9e87-492f291c51652023-10-11WarningsExact identifier
application number: M021
UNITED Asutra TC Kit ColgateSODIUM MONOFLUOROPHOSPHATEProcurall Solutions042817f9-675f-056a-e063-6394a90a2d972023-08-30WarningsExact identifier
application number: M021
Colgate Max Fresh Cool MintSODIUM FLUORIDEMission Hills S.A de C.Vd142e43f-415a-41c5-a7db-8b18a039a3232019-04-09WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN879dfaf0-27c8-41a3-8d01-a1c3eec9edfc2
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD879dfaf0-27c8-41a3-8d01-a1c3eec9edfc2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY879dfaf0-27c8-41a3-8d01-a1c3eec9edfc2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY879dfaf0-27c8-41a3-8d01-a1c3eec9edfc2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY879dfaf0-27c8-41a3-8d01-a1c3eec9edfc2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY879dfaf0-27c8-41a3-8d01-a1c3eec9edfc2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52000-112-0152000011201181 g in 1 TUBE (52000-112-01) 181 g2020-05-300000-00-00NoNoCurrent