FDA.reportPublic FDA data

Clinpro 5000

Product NDC
48878-3120
11-digit product format
488783120
Labeler code
48878
Product ID
48878-3120_d7b1ca1b-115c-4bc3-8f92-87720f77d2f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sodium fluoride
Dosage form
PASTE, DENTIFRICE
Route
ORAL
Labeler
Solventum US LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2009-01-01
Substance
SODIUM FLUORIDE
Active strength
5 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clinpro 5000
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
392038Internal RxNorm lookup
1006558Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a20d3cf0-2e1f-4191-971e-9e47936b4580Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48878-3120-4Clinpro 50001 in 1 BOXPASTE, DENTIFRICE19
48878-3120-4Clinpro 5000113 g in 1 TUBEPASTE, DENTIFRICE1139
48878-3120-1Clinpro 50001 in 1 BOXPASTE, DENTIFRICE16
48878-3120-1Clinpro 5000113 g in 1 TUBEPASTE, DENTIFRICE1136
48878-3120-2Clinpro 5000113 g in 1 TUBEPASTE, DENTIFRICE1136
48878-3120-2Clinpro 50001 in 1 BOXPASTE, DENTIFRICE16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
48878-3120-4GM - Gram48878-312084a4a8af-fbcc-4e6c-b1e7-6ef54b0f195d12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
sodium fluorideACTIVE INGREDIENT8ZYQ1474W7CLINPRO 5000 (SODIUM FLUORIDE) PASTE, DENTIFRICE [3M ESPE DENTAL PRODUCTS]3
fluoride ionACTIVE MOIETYQ80VPU408OCLINPRO 5000 (SODIUM FLUORIDE) PASTE, DENTIFRICE [3M ESPE DENTAL PRODUCTS]3
carboxymethylcellulose sodiumINACTIVE INGREDIENTK679OBS311CLINPRO 5000 (SODIUM FLUORIDE) PASTE, DENTIFRICE [3M ESPE DENTAL PRODUCTS]3
glycerinINACTIVE INGREDIENTPDC6A3C0OXCLINPRO 5000 (SODIUM FLUORIDE) PASTE, DENTIFRICE [3M ESPE DENTAL PRODUCTS]3
polyethylene glycolINACTIVE INGREDIENT3WJQ0SDW1ACLINPRO 5000 (SODIUM FLUORIDE) PASTE, DENTIFRICE [3M ESPE DENTAL PRODUCTS]3
saccharin sodiumINACTIVE INGREDIENTSB8ZUX40TYCLINPRO 5000 (SODIUM FLUORIDE) PASTE, DENTIFRICE [3M ESPE DENTAL PRODUCTS]3
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4CLINPRO 5000 (SODIUM FLUORIDE) PASTE, DENTIFRICE [3M ESPE DENTAL PRODUCTS]3
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JCLINPRO 5000 (SODIUM FLUORIDE) PASTE, DENTIFRICE [3M ESPE DENTAL PRODUCTS]3
sorbitolINACTIVE INGREDIENT506T60A25RCLINPRO 5000 (SODIUM FLUORIDE) PASTE, DENTIFRICE [3M ESPE DENTAL PRODUCTS]3
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCLINPRO 5000 (SODIUM FLUORIDE) PASTE, DENTIFRICE [3M ESPE DENTAL PRODUCTS]3
tricalcium phosphateINACTIVE INGREDIENTK4C08XP666CLINPRO 5000 (SODIUM FLUORIDE) PASTE, DENTIFRICE [3M ESPE DENTAL PRODUCTS]3
waterINACTIVE INGREDIENT059QF0KO0RCLINPRO 5000 (SODIUM FLUORIDE) PASTE, DENTIFRICE [3M ESPE DENTAL PRODUCTS]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48878-3120CLINPRO 5000 (SODIUM FLUORIDE) PASTE, DENTIFRICE [SOLVENTUM US LLC]9Current NDC, Legacy NDC, 2 package rows20240806_a20d3cf0-2e1f-4191-971e-9e47936b4580.zip
48878-3120CLINPRO 5000 (SODIUM FLUORIDE) PASTE, DENTIFRICE [SOLVENTUM US LLC]6Current NDC, Legacy NDC, 4 package rows20240806_f982709b-c486-43a8-b17c-6957092e8f3c.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clinpro 5000SODIUM FLUORIDESolventum US LLCa20d3cf0-2e1f-4191-971e-9e47936b45802024-08-01Warnings, Adverse reactionsExact identifier
ndc (product): 48878-3120

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1006558Clinpro 5000 1.1 % ToothpastePSNa20d3cf0-2e1f-4191-971e-9e47936b45809
392038sodium fluoride 1.1 % ToothpastePSNa20d3cf0-2e1f-4191-971e-9e47936b45809
1006558sodium fluoride 0.011 MG/MG Toothpaste [Clinpro 5000]SBDa20d3cf0-2e1f-4191-971e-9e47936b45809
392038sodium fluoride 0.011 MG/MG ToothpasteSCDa20d3cf0-2e1f-4191-971e-9e47936b45809
1006558Clinpro 5000 0.011 MG/MG ToothpasteSYa20d3cf0-2e1f-4191-971e-9e47936b45809
1006558Clinpro 5000 1.1 % ToothpasteSYa20d3cf0-2e1f-4191-971e-9e47936b45809
392038sodium fluoride 1.1 % (fluoride ion 0.5 % ) ToothpasteSYa20d3cf0-2e1f-4191-971e-9e47936b45809
392038sodium fluoride 1.1 % Dental GelSYa20d3cf0-2e1f-4191-971e-9e47936b45809
1006558Clinpro 5000 1.1 % ToothpastePSNf982709b-c486-43a8-b17c-6957092e8f3c6
392038sodium fluoride 1.1 % ToothpastePSNf982709b-c486-43a8-b17c-6957092e8f3c6
1006558sodium fluoride 0.011 MG/MG Toothpaste [Clinpro 5000]SBDf982709b-c486-43a8-b17c-6957092e8f3c6
392038sodium fluoride 0.011 MG/MG ToothpasteSCDf982709b-c486-43a8-b17c-6957092e8f3c6
1006558Clinpro 5000 0.011 MG/MG ToothpasteSYf982709b-c486-43a8-b17c-6957092e8f3c6
1006558Clinpro 5000 1.1 % ToothpasteSYf982709b-c486-43a8-b17c-6957092e8f3c6
392038sodium fluoride 1.1 % (fluoride ion 0.5 % ) ToothpasteSYf982709b-c486-43a8-b17c-6957092e8f3c6
392038sodium fluoride 1.1 % Dental GelSYf982709b-c486-43a8-b17c-6957092e8f3c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
48878-3120-1488783120011 in 1 BOXHistorical
48878-3120-248878312002113 g in 1 TUBE113 gHistorical
48878-3120-4488783120041 TUBE in 1 BOX (48878-3120-4) / 113 g in 1 TUBE1 tube2009-01-010000-00-00NoNoCurrent