FDA.reportPublic FDA data

Crest Kids Advanced Color Changing

Product NDC
58933-024
11-digit product format
589330024
Labeler code
58933
Product ID
58933-024_47e5694e-bda6-f2c3-e063-6294a90a633b
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
2025-10-15
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
1.5 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 MONOFLUOROPHOSPHATE1.5 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
451283d3-78b0-8361-e063-6294a90a1fd5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58933-024-04Crest Kids Advanced Color Changing4 in 1 CELLO PACKPASTE, DENTIFRICE43
58933-024-04Crest Kids Advanced Color Changing1 in 1 CARTONPASTE, DENTIFRICE13
58933-024-42Crest Kids Advanced Color Changing1 in 1 CARTONPASTE, DENTIFRICE13
58933-024-42Crest Kids Advanced Color Changing119 g in 1 TUBEPASTE, DENTIFRICE1193

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 39 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ORCA Pain Reliever Putty with MentholMENTHOLORCA Products, LLC188cb01a-3d0f-43d9-983e-6475c0c5b06e2023-11-10WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC33fbdbc7-e10d-4181-926f-9b591b5b07e32023-11-08WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC0d2c8c0c-4c72-4400-b3b5-ed578fa351672023-11-08WarningsExact identifier
application number: M022
Hydrogen PeroxideHYDROGEN PEROXIDEDegasa, S.A. de C.V.45ac0275-4c68-3897-e054-00144ff8d46c2023-11-05WarningsExact identifier
application number: M022
Oral Pain ReliefBENZOCAINEGERI-CARE PHARMACEUTICAL CORPd294a39e-55f4-272d-e053-2995a90ab7f72023-10-31WarningsExact identifier
application number: M022
AvantBENZOCAINEDharma Research, Inc.e10c45e6-d37f-4650-b3e5-07719cc0ea492023-10-11WarningsExact identifier
application number: M022
AvantBENZOCAINEDharma Research, Inc.886d949b-8db1-499c-a277-174f8bc29f342023-10-11WarningsExact identifier
application number: M022
AvantBENZOCAINEDharma Research, Inc.fc8194af-2e77-4ad1-ae75-461dce3ed6042023-10-11WarningsExact identifier
application number: M022
AvantBENZOCAINEDharma Research, Inc.baf7d184-07ed-4491-a1fc-9a377b4b01102023-10-11WarningsExact identifier
application number: M022
AvantBENZOCAINEDharma Research, Inc.033034af-c86c-4dbf-90eb-009c117024c62023-10-11WarningsExact identifier
application number: M022
AvantBENZOCAINEDharma Research, Inc.658ada18-2334-4b4e-b08e-702fa127aa142023-10-11WarningsExact identifier
application number: M022
AvantBENZOCAINEDharma Research, Inc.cad932e5-8d7f-4f20-b1c2-febd328152f02023-10-11WarningsExact identifier
application number: M022
IoliteBENZOCAINEDharma Research, Inc.2c9519ab-320d-49da-9deb-97a6168fb0882023-10-10WarningsExact identifier
application number: M022
IolineBENZOCAINEDharma Research, Inc.b862c974-c024-42c3-986e-b65069437c7b2023-10-10WarningsExact identifier
application number: M022
IoliteBENZOCAINEDharma Research, Inc.651ea978-081d-4c59-b177-6049a69d94152023-10-10WarningsExact identifier
application number: M022
IoliteBENZOCAINEDharma Research, Inc.db763237-2910-45b9-be72-da092edc951b2023-10-10WarningsExact identifier
application number: M022
IoliteBENZOCAINEDharma Research, Inc.34316f93-10b4-41cc-8654-625283f0044c2023-10-10WarningsExact identifier
application number: M022
IoliteBENZOCAINEDharma Research, Inc.142a8824-657e-492a-8e5a-b15eb73383c92023-10-10WarningsExact identifier
application number: M022
IoliteBENZOCAINEDharma Research, Inc.414cbec9-94e2-4bca-908b-1e79f8db0b272023-10-10WarningsExact identifier
application number: M022
Sore throat cherryPHENOLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)de634cf1-ed39-4d8a-8855-006c69b7aee92023-10-10WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2637680sodium monofluorophosphate 0.834 % ToothpastePSN451283d3-78b0-8361-e063-6294a90a1fd53
2637680sodium monofluorophosphate 0.00834 MG/MG ToothpasteSCD451283d3-78b0-8361-e063-6294a90a1fd53
2637680sodium monofluorophosphate 0.834 % (fluoride 0.15 % ) ToothpasteSY451283d3-78b0-8361-e063-6294a90a1fd53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58933-024-04589330024044 CARTON in 1 CELLO PACK (58933-024-04) / 1 TUBE in 1 CARTON / 119 g in 1 TUBE4 carton2025-10-15NoNoCurrent
58933-024-42589330024421 TUBE in 1 CARTON (58933-024-42) / 119 g in 1 TUBE1 tube2025-10-15NoNoCurrent