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 36 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetaminophenACETAMINOPHENNuCare Pharmaceuticals,Inc.872365ca-0c6b-550a-e053-2a91aa0ab25a2024-06-14WarningsExact identifier
application number: M022
Amosan Oral Wound Cleanser SpearmintSODIUM PERBORATE MONOHYDRATEVintage Brands Limited7ac6c649-758f-4128-9920-466c0967b86a2024-05-21WarningsExact identifier
application number: M022
SensodynePOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC9e8e7b9f-3ccd-4935-b886-93f3a5045b672024-05-15WarningsExact identifier
application number: M022
Sensodyne Extra WhiteningPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC1ed4a62b-f1d3-4740-8150-b94e023987402024-05-15WarningsExact identifier
application number: M022
Attitude Adult Fluoride-free - Sensitive - SpearmintPOTASSIUM NITRATE9055-7588 Qubec Inc. DBA Attitude46d5c908-f0e3-444c-9d96-461feef391372024-05-14WarningsExact identifier
application number: M022
sensodynePOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC16225f06-1d40-416a-aaec-7890e398fe4b2024-05-13WarningsExact identifier
application number: M022
Sore Throat CherryPHENOLQUALITY CHOICE (Chain Drug Marketing Association)9162ae27-ddbb-4336-9655-487995919de42024-05-01WarningsExact identifier
application number: M022
BIO SPECTRA ATTITUDESODIUM FLUORIDE AND POTASSIUM NITRATE9055-7588 Quebec Inc. DBA Attitude42b79ec5-f37f-4dc9-9631-c8b1c153fe882024-04-26WarningsExact identifier
application number: M022
Quality Choice Oral Pain ReliefBENZOCAINE 20%, BENZALKONIUM CHLORIDE 1%Quality Choice (CHAIN DRUG MARKETING ASSOCIATION)162702b4-4bf7-8868-e063-6294a90a59212024-04-15WarningsExact identifier
application number: M022
Gelato Topical AnestheticBENZOCAINEMycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc9991de96-99a1-42f0-9ddd-e530ca9ceab12024-04-11WarningsExact identifier
application number: M022
Aquafresh Extreme Clean Pure Breath ActionSODIUM FLUORIDEHaleon US Holdings LLC462eb309-deca-4464-b13a-7ae314e53ede2024-04-08WarningsExact identifier
application number: M022
Sore Throat CherryPHENOLFamily Dollar (FAMILY WELLNESS)7806fac7-736e-44b0-baa2-42feb72374172024-03-27WarningsExact identifier
application number: M022
SucretsDYCLONINE HCL, MENTHOL, AND PECTINInsight Pharmaceuticals LLC2a2839ea-11d3-4390-930d-0da912a9c6f52024-03-20WarningsExact identifier
application number: M022
Sucrets Sore Throat Wild CherryDYCLONINE HYDROCHLORIDEInsight Pharmaceuticals LLCda4967c7-ee18-42e7-8c97-8919f3bb1b7d2024-03-20WarningsExact identifier
application number: M022
NATEAN Clean plus Sensitivity ReliefPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLCcea6f992-8a44-4eb8-baea-97b7b181b2272024-03-19WarningsExact identifier
application number: M022
NATEAN Clean and WhitenSODIUM FLUORIDEHaleon US Holdings LLC71b95962-2693-49f5-94d2-f2a035b5e0c82024-03-19WarningsExact identifier
application number: M022
SENSODYNE Sensitivity and Gum MintSTANNOUS FLUORIDEHaleon US Holdings LLCed093acd-255c-40ff-a010-d276f58444532024-03-07WarningsExact identifier
application number: M022
SENSODYNE Sensitivity Gum and Enamel MintSTANNOUS FLUORIDEHaleon US Holdings LLCd4e9e5cf-d058-4c3f-ab5e-0b5a20a012e22024-03-07WarningsExact identifier
application number: M022
Sensodyne True whitePOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC671f8f45-389c-4375-be43-f5500ee21a0e2024-03-07WarningsExact identifier
application number: M022
Sensodyne Pronamel Strong and Bright Enamel MintPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLCbe1ae382-0e01-4db8-90d7-fdadec2ff8612024-03-06WarningsExact 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