FDA.reportPublic FDA data

Clinpro 5000

Product NDC
48878-3140
11-digit product format
488783140
Labeler code
48878
Product ID
48878-3140_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
2011-01-07
Substance
SODIUM FLUORIDE
Active strength
5 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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): 48878-3140

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
48878-3140-4Clinpro 5000113 g in 1 TUBEPASTE, DENTIFRICE1139
48878-3140-4Clinpro 50001 in 1 BOXPASTE, DENTIFRICE19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
48878-3140-4GM - Gram48878-314003d1c1cd-c7b1-4cca-a3cf-3275f12aee7712015-10-02

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
48878-3140CLINPRO 5000 (SODIUM FLUORIDE) PASTE, DENTIFRICE [SOLVENTUM US LLC]9Current NDC, Legacy NDC, 2 package rows20240806_a20d3cf0-2e1f-4191-971e-9e47936b4580.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
48878-3140-4488783140041 TUBE in 1 BOX (48878-3140-4) / 113 g in 1 TUBE1 tube2011-01-070000-00-00NoNoCurrent