FDA.reportPublic FDA data

Clinpro Tooth Creme

Manufacturer
Solventum US LLC | Sheffield Pharmaceuticals LLC
Effective date
2024-08-01
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 00:16:41

Label at a glance#

ProductClinpro Tooth Creme
Active ingredientsodium fluoride
Label structure6 sections

Label contents#

Full prescribing information#

Principal Display Panel - 24g Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3M ESPE

Clinpro™ Tooth Crème

0.21% w/w Sodium Fluoride Anti-Cavity Paste with Tri-Calcium Phosphate

24g

Vanilla Mint

Principal Display Panel - 24g Carton Label
Principal Display Panel - 24g Carton Label

Principal Display Panel – 24g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3M ESPE

Clinpro™ Tooth Crème

0.21% w/w Sodium Fluoride Anti-Cavity Paste with Tri-Calcium Phosphate

24g

Vanilla Mint

Principal Display Panel – 24g Tube Label
Principal Display Panel – 24g Tube Label

Principal Display Panel - 90 mL Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3M ESPE

Clinpro™ Tooth Crème

0.21% w/w Sodium Fluoride Anti-Cavity Paste with Tri-Calcium Phosphate (950 ppm F-)

90 ml

Vanilla Mint

Principal Display Panel - 90 mL Carton Label
Principal Display Panel - 90 mL Carton Label

Principal Display Panel - 90 mL Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3M ESPE

Clinpro™ Tooth Crème

0.21% w/w Sodium Fluoride Anti-Cavity Paste with Tri-Calcium Phosphate (950 ppm F-)

90 ml

Vanilla Mint

Principal Display Panel - 90 mL Tube Label
Principal Display Panel - 90 mL Tube Label

Principal Display Panel - 113g Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3M ESPE

Clinpro™ Tooth Crème

0.21% w/w Sodium Fluoride Anti-Cavity Paste with Tri-Calcium Phosphate

113g

Vanilla Mint

Principal Display Panel - 113g Carton Label
Principal Display Panel - 113g Carton Label

Principal Display Panel - 113g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3M ESPE

Clinpro™ Tooth Crème

0.21% w/w Sodium Fluoride Anti-Cavity Paste with Tri-Calcium Phosphate

113g

Vanilla Mint

Principal Display Panel - 113g Tube Label
Principal Display Panel - 113g Tube Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1099038sodium fluoride 0.21 % ToothpastePSN9
1099038sodium fluoride 0.0021 MG/MG ToothpasteSCD9
1099038sodium fluoride 0.21 % ToothpasteSY9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48878-3150-1Clinpro Tooth Creme1 in 1 BOXPASTE, DENTIFRICE19
48878-3150-1Clinpro Tooth Creme113 g in 1 TUBEPASTE, DENTIFRICE1139
48878-3150-2Clinpro Tooth Creme1 in 1 BOXPASTE, DENTIFRICE19
48878-3150-2Clinpro Tooth Creme24 g in 1 TUBEPASTE, DENTIFRICE249
48878-3150-5Clinpro Tooth Creme90 g in 1 TUBEPASTE, DENTIFRICE909
48878-3150-5Clinpro Tooth Creme1 in 1 BOXPASTE, DENTIFRICE19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48878-3150CLINPRO TOOTH CREME (SODIUM FLUORIDE) PASTE, DENTIFRICE [SOLVENTUM US LLC]9Current NDC, Legacy NDC, 6 package rows20240807_5b85a10c-90ec-4148-849f-0e9f694530aa.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
48878-315048878-3150-1, 48878-3150-2, 48878-3150-5

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
sodium fluoride8ZYQ1474W7ACTIM
Water059QF0KO0RIACT
Sorbitol506T60A25RIACT
Silicon DioxideETJ7Z6XBU4IACT
GlycerinPDC6A3C0OXIACT
Polyethylene Glycol, Unspecified3WJQ0SDW1AIACT
Sodium Lauryl Sulfate368GB5141JIACT
Titanium Dioxide15FIX9V2JPIACT
Carboxymethylcellulose SodiumK679OBS311IACT
Saccharin SodiumSB8ZUX40TYIACT
Tricalcium PhosphateK4C08XP666IACT

Source Document#

Source XML · Source PDF

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 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clinpro Tooth CremeSODIUM FLUORIDESolventum US LLC786c6184-6bc8-4376-9ce2-3e35af1932102024-08-01WarningsExact identifier
ndc (product): 48878-3150
e7eb348c-00df-48a6-bae5-c31f273c5a925b85a10c-90ec-4148-849f-0e9f694530aa2024-08-01Exact identifier
spl id: e7eb348c-00df-48a6-bae5-c31f273c5a92
spl set id: 5b85a10c-90ec-4148-849f-0e9f694530aa

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.