FDA.reportPublic FDA data

Crest Kids Advanced Color Changing

Product NDC
58933-012
11-digit product format
589330012
Labeler code
58933
Product ID
58933-012_47e54e5e-4bd6-00ce-e063-6394a90a99e8
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Monofluorophosphate
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Procter & Gamble Manufactura, S de R.L. de C.V.
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-01-01
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
1.6 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
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
Crest Kids Advanced Color Changing
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM MONOFLUOROPHOSPHATE1.6 mg/g

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
2637680Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fc86b98e-d556-4769-e053-6394a90afc6eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58933-012-02Crest Kids Advanced Color Changing1 in 1 CARTONPASTE, DENTIFRICE18
58933-012-02Crest Kids Advanced Color Changing2 in 1 CELLO PACKPASTE, DENTIFRICE28
58933-012-03Crest Kids Advanced Color Changing119 g in 1 TUBEPASTE, DENTIFRICE1198
58933-012-03Crest Kids Advanced Color Changing2 in 1 CARTONPASTE, DENTIFRICE28
58933-012-04Crest Kids Advanced Color Changing119 g in 1 TUBEPASTE, DENTIFRICE1198
58933-012-04Crest Kids Advanced Color Changing4 in 1 CARTONPASTE, DENTIFRICE48
58933-012-29Crest Kids Advanced Color Changing82 g in 1 TUBEPASTE, DENTIFRICE828
58933-012-29Crest Kids Advanced Color Changing1 in 1 CARTONPASTE, DENTIFRICE18
58933-012-31Crest Kids Advanced Color Changing133 g in 1 TUBEPASTE, DENTIFRICE1338
58933-012-31Crest Kids Advanced Color Changing3 in 1 CARTONPASTE, DENTIFRICE38
58933-012-42Crest Kids Advanced Color Changing1 in 1 CARTONPASTE, DENTIFRICE18
58933-012-42Crest Kids Advanced Color Changing119 g in 1 TUBEPASTE, DENTIFRICE1198
58933-012-85Crest Kids Advanced Color Changing24 g in 1 TUBEPASTE, DENTIFRICE248
58933-012-85Crest Kids Advanced Color Changing1 in 1 CARTONPASTE, DENTIFRICE18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58933-012CREST KIDS ADVANCED COLOR CHANGING (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [PROCTER & GAMBLE MANUFACTURA, S DE R.L. DE C.V.]5Current NDC, 14 package rows20250411_fc86b98e-d556-4769-e053-6394a90afc6e.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 35 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ChloraspeticMENTHOL AND BENZOCAINEPrestige Brands Holdings, Inc.2b1808b2-2574-4ab8-a762-5733251848ce2024-10-25WarningsExact identifier
application number: M022
Chloraseptic Warming Sore ThroatPHENOLPrestige Brands Holdings, Inc.a197fab2-70ce-4a6c-9add-29d7368a75c52024-10-25WarningsExact identifier
application number: M022
Gly-OxideCARBAMIDE PEROXIDEMedtech Products Inc.086a0b82-e947-41c9-89e7-ba06483960c92024-10-25WarningsExact identifier
application number: M022
CHLORASEPTICMENTHOL AND BENZOCAINEPrestige Brands Holdings, Inc.d500f423-b9f2-4d98-8f2a-8bab7c05737c2024-10-25WarningsExact identifier
application number: M022
CHLORASEPTICMENTHOL AND BENZOCAINEPrestige Brands Holdings, Inc.b30e4b32-89dd-4e53-81d5-1415105361d42024-10-25WarningsExact identifier
application number: M022
Finafta MultiOralBENZOCAINEEfficient Laboratories Inc.28c5a993-fb5f-4091-af15-32ccae4b9a7d2024-10-14WarningsExact identifier
application number: M022
Rexall Sensitive FreshmintPOTASSIUM NITRATE, SODIUM FLUORIDEOld East Main CO.7e715bb9-666e-4de4-ba70-1c84f52434432024-10-14WarningsExact identifier
application number: M022
Rexall Sensitive Extra WhiteningPOTASSIUM NITRATE, SODIUM FLUORIDEOld East Main CO.2daf18a3-f71e-4585-8128-4663eff7eb6d2024-10-14WarningsExact identifier
application number: M022
Anadent Kanka GelBENZOCAINEBELMORA LLCe0f73d78-5db1-43b4-8f58-e5410ca4560f2024-10-04WarningsExact identifier
application number: M022
Listerine Cool Mint AntisepticEUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOLNavajo Manufacturing Company Inc.f5f26e2f-8a1f-4687-e053-2a95a90ae3782024-10-03WarningsExact identifier
application number: M022
Colgate Great Regular FlavorSODIUM MONOFLUOROPHOSPHATENavajo Manufacturing Company Inc.f89bf259-b738-8229-e053-6394a90a0c592024-10-03WarningsExact identifier
application number: M022
Colgate Total SF Clean MintSTANNOUS FLUORIDENavajo Manufacturing Company Inc.f71c53e0-e2dd-16f9-e053-6394a90accff2024-10-03WarningsExact identifier
application number: M022
Crest Pro HealthCETYLPYRIDINIUM CHLORIDENavajo Manufacturing Company Inc.65bf17a9-21ad-27cb-e053-2991aa0afc402024-10-02WarningsExact identifier
application number: M022
Sensodyne Pronamel Gentle Whitening AdvancedPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC94e07979-943b-45bb-8e2b-90d686f3692e2024-09-04WarningsExact identifier
application number: M022
Sensodyne Pronamel Gentle Whitening Advanced PlusPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLC6eb304dd-2a24-4fa0-9d39-71264e88dd162024-08-29WarningsExact identifier
application number: M022
Sensodyne Pronamel Clinical Enamel Strength Deep CleanPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLCcfda7efa-86fa-470d-a79f-81907e31778a2024-08-14WarningsExact identifier
application number: M022
Sensodyne Pronamel Kids Bubble TwistSODIUM FLUORIDEHaleon US Holdings LLCe403529a-0fac-4dab-b75c-46906add096b2024-08-13WarningsExact identifier
application number: M022
Calcium Carbonate Assorted FlavorsANTACID TABLETSNuCare Pharmaceuticals,Inc.af10dfb6-fef3-3410-e053-2995a90a91302024-07-17WarningsExact identifier
application number: M022
SENSODYNE Advanced Whitening PlusPOTASSIUM NITRATEHaleon US Holdings LLCf757ccdd-b316-4799-a34a-10edbb73da6b2024-07-12WarningsExact identifier
application number: M022
dentalux SENSITIVE ANTI-CAVITY FLUORIDEPOTASSIUM NITRATE, SODIUM FLUORIDELidl US, LLCbaef7f15-8082-4e61-8c08-8beda8ad40c02024-07-03WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2637680sodium monofluorophosphate 0.834 % ToothpastePSNfc86b98e-d556-4769-e053-6394a90afc6e8
2637680sodium monofluorophosphate 0.00834 MG/MG ToothpasteSCDfc86b98e-d556-4769-e053-6394a90afc6e8
2637680sodium monofluorophosphate 0.834 % (fluoride 0.15 % ) ToothpasteSYfc86b98e-d556-4769-e053-6394a90afc6e8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58933-012-02589330012022 CARTON in 1 CELLO PACK (58933-012-02) / 1 TUBE in 1 CARTON / 119 g in 1 TUBE2 carton2025-01-05NoNoCurrent
58933-012-03589330012032 TUBE in 1 CARTON (58933-012-03) / 119 g in 1 TUBE2 tube2025-01-07NoNoCurrent
58933-012-04589330012044 TUBE in 1 CARTON (58933-012-04) / 119 g in 1 TUBE4 tube2023-01-01NoNoCurrent
58933-012-29589330012291 TUBE in 1 CARTON (58933-012-29) / 82 g in 1 TUBE1 tube2023-01-01NoNoCurrent
58933-012-31589330012313 TUBE in 1 CARTON (58933-012-31) / 133 g in 1 TUBE3 tube2023-01-01NoNoCurrent
58933-012-42589330012421 TUBE in 1 CARTON (58933-012-42) / 119 g in 1 TUBE1 tube2023-01-01NoNoCurrent
58933-012-85589330012851 TUBE in 1 CARTON (58933-012-85) / 24 g in 1 TUBE1 tube2023-01-01NoNoCurrent