FDA.reportPublic FDA data

Clinpro Tooth Creme

Product NDC
48878-3150
11-digit product format
488783150
Labeler code
48878
Product ID
48878-3150_8908ee6d-3159-423d-bba3-502931790708
Type
HUMAN OTC DRUG
Nonproprietary name
sodium fluoride
Dosage form
PASTE, DENTIFRICE
Route
ORAL
Labeler
Solventum US LLC
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-07-18
Substance
SODIUM FLUORIDE
Active strength
.95 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
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
Clinpro Tooth Creme
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.95 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1099038Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
786c6184-6bc8-4376-9ce2-3e35af193210Available on FDA.report

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
48878-3150-4Clinpro Tooth Creme1 in 1 BOXPASTE, DENTIFRICE17
48878-3150-4Clinpro Tooth Creme113 g in 1 TUBEPASTE, DENTIFRICE1137

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
sodium fluorideACTIVE INGREDIENT8ZYQ1474W7CLINPRO TOOTH CREME (SODIUM FLUORIDE) PASTE, DENTIFRICE [3M ESPE DENTAL PRODUCTS]1
fluoride ionACTIVE MOIETYQ80VPU408OCLINPRO TOOTH CREME (SODIUM FLUORIDE) PASTE, DENTIFRICE [3M ESPE DENTAL PRODUCTS]1
carboxymethylcellulose sodiumINACTIVE INGREDIENTK679OBS311CLINPRO TOOTH CREME (SODIUM FLUORIDE) PASTE, DENTIFRICE [3M ESPE DENTAL PRODUCTS]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXCLINPRO TOOTH CREME (SODIUM FLUORIDE) PASTE, DENTIFRICE [3M ESPE DENTAL PRODUCTS]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACLINPRO TOOTH CREME (SODIUM FLUORIDE) PASTE, DENTIFRICE [3M ESPE DENTAL PRODUCTS]1
saccharin sodiumINACTIVE INGREDIENTSB8ZUX40TYCLINPRO TOOTH CREME (SODIUM FLUORIDE) PASTE, DENTIFRICE [3M ESPE DENTAL PRODUCTS]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4CLINPRO TOOTH CREME (SODIUM FLUORIDE) PASTE, DENTIFRICE [3M ESPE DENTAL PRODUCTS]1
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JCLINPRO TOOTH CREME (SODIUM FLUORIDE) PASTE, DENTIFRICE [3M ESPE DENTAL PRODUCTS]1
sorbitolINACTIVE INGREDIENT506T60A25RCLINPRO TOOTH CREME (SODIUM FLUORIDE) PASTE, DENTIFRICE [3M ESPE DENTAL PRODUCTS]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCLINPRO TOOTH CREME (SODIUM FLUORIDE) PASTE, DENTIFRICE [3M ESPE DENTAL PRODUCTS]1
tricalcium phosphateINACTIVE INGREDIENTK4C08XP666CLINPRO TOOTH CREME (SODIUM FLUORIDE) PASTE, DENTIFRICE [3M ESPE DENTAL PRODUCTS]1
waterINACTIVE INGREDIENT059QF0KO0RCLINPRO TOOTH CREME (SODIUM FLUORIDE) PASTE, DENTIFRICE [3M ESPE DENTAL PRODUCTS]1

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
48878-3150CLINPRO TOOTH CREME (SODIUM FLUORIDE) PASTE, DENTIFRICE [SOLVENTUM US LLC]7Current NDC, Legacy NDC, 2 package rows20240807_786c6184-6bc8-4376-9ce2-3e35af193210.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 32 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colgate Anticavity KitSODIUM MONOFLUOROPHOSPHATEMing Fai Industrial (Shenzhen) Co. Ltd86dfd09d-f3b6-4c4b-852d-7e04dc5c8fec2025-12-05WarningsExact identifier
application number: M021
Dr. Jen SuperPaste Nano-HydroxyapatiteSODIUM FLUORIDEDr Jen Natural, LLC8b28b857-9162-4065-b0a0-571efffe97872025-12-05WarningsExact identifier
application number: M021
Dr. Jen SuperPaste OrthoSODIUM FLUORIDEDr Jen Natural, LLC9dd248bf-9488-43cd-a041-e8315a05ce5d2025-12-04WarningsExact identifier
application number: M021
Dr. Jen SuperPaste PerioSODIUM FLUORIDEDr Jen Natural, LLC8c7e6d3a-49d9-4098-9d5e-e9792b3735742025-12-04WarningsExact identifier
application number: M021
Colgate Total Plaque CleanseSTANNOUS FLUORIDEColgate-Palmolive Companyb2980238-5bcb-467f-9e90-a307938632c22025-12-03WarningsExact identifier
application number: M021
Advance White Extreme Whitening Tartar ControlSODIUM FLUORIDEChurch & Dwight Co., Inc.b539264f-e1ff-440b-af76-84266fe2c0a22025-12-02WarningsExact identifier
application number: M021
Sensodyne Pronamel Clinical Enamel Strength Fresh BreathPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLC34a1a32e-3017-f018-e063-6394a90a02302025-12-01WarningsExact identifier
application number: M021
PRO-SYSSODIUM FLUORIDE AND POTASSIUM NITRATEBenco Dental4e470ba4-60bb-1815-e063-6294a90abacc2025-12-01WarningsExact identifier
application number: M021
PRO-SYSSODIUM FLUORIDEBenco Dental4e539cb2-bcbd-95fc-e063-6294a90a21212025-12-01WarningsExact identifier
application number: M021
Cool sense Care PlusSODIUM FLUORIDEDONG IL PHARMS CO., LTD.44763bf6-caf3-ec69-e063-6394a90a0ee12025-11-25WarningsExact identifier
application number: M021
DOCTRUST DOUBLEX ToothSODIUM FLUORIDEDONG IL PHARMS CO.,LTD44765e86-2eb2-6381-e063-6394a90a761f2025-11-25WarningsExact identifier
application number: M021
TheraBreath for Kids Anticavity Wacky WatermelonSODIUM FLUORIDEChurch & Dwight Co., Inc.578f8010-6b1c-4c6b-91d3-e483ace40f662025-11-25WarningsExact identifier
application number: M021
Sensodyne Cavity and SensitivityPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLCd002074b-0580-4247-b3c7-121b8c0986972025-11-24WarningsExact identifier
application number: M021
CVS Pharmacy Enamel GuardFLUORIDECVS Pharmacy18295a1c-c2a6-489b-be34-9252b9e1e2b82025-11-21WarningsExact identifier
application number: M021
365 Everyday Value Cavity Fighting and WhiteningSODIUM MONOFLOUROPHOSPHATEWhole Foods Market, Inc.83704717-19bc-2634-e053-2991aa0a29792025-11-21WarningsExact identifier
application number: M021
WhiteningMONOFLUOROPHOSPHATETarget0074630f-9d8d-9209-e063-6294a90a4f012025-11-21WarningsExact identifier
application number: M021
Rite Aid Enamel GuardFLUORIDERite Aid67c1fc04-0f21-4944-8b9d-0d8ffd0518742025-11-21WarningsExact identifier
application number: M021
ME MOTHER EARTHZERO WASTE TOOTHPASTE TABLETS PEPPERMINTA PLUS MERCHANDISE LLC43d30abc-889a-5377-e063-6294a90ab8042025-11-17WarningsExact identifier
application number: M021
Natural White Sensitivity and GumSTANNOUS FLUORIDELornamead Products2e83bda8-4d4b-640f-e063-6294a90abc602025-11-14WarningsExact identifier
application number: M021
CVS Pharmacy Restore and DefendFLUORIDECVS Pharmacy99f86135-05b7-42b1-aef5-df4513259b8f2025-11-14WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099038sodium fluoride 0.21 % ToothpastePSN5b85a10c-90ec-4148-849f-0e9f694530aa9
1099038sodium fluoride 0.0021 MG/MG ToothpasteSCD5b85a10c-90ec-4148-849f-0e9f694530aa9
1099038sodium fluoride 0.21 % ToothpasteSY5b85a10c-90ec-4148-849f-0e9f694530aa9
1099038sodium fluoride 0.21 % ToothpastePSN786c6184-6bc8-4376-9ce2-3e35af1932107
1099038sodium fluoride 0.0021 MG/MG ToothpasteSCD786c6184-6bc8-4376-9ce2-3e35af1932107
1099038sodium fluoride 0.21 % ToothpasteSY786c6184-6bc8-4376-9ce2-3e35af1932107

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
48878-3150-1488783150011 in 1 BOXHistorical
48878-3150-2488783150021 in 1 BOXHistorical
48878-3150-4488783150041 TUBE in 1 BOX (48878-3150-4) / 113 g in 1 TUBE1 tube2013-07-180000-00-00NoNoCurrent
48878-3150-54887831500590 g in 1 TUBE90 gHistorical