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 Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui392038, 1006558

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

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