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 16 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Toms of Maine Whiten Plus Deep Clean PeppermintSODIUM FLUORIDETom's of Maine4c535776-3f80-4eeb-bb63-2d734c3c3a6b2026-02-18WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEUnited Natural Foods, Inc. dba UNFIdd6bf8df-1e28-4f61-b876-b9f1f8d5993a2026-02-17Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEUnited Natural Foods, Inc. dba UNFI8283cea0-7b62-4796-8763-6654039664cd2026-02-17Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEUnited Natural Foods, Inc. dba UNFI9d055fed-26d8-4827-a4cc-8c314514a6c32026-02-17WarningsExact identifier
application number: M021
Brush Buddies Crayola Color Changing ANTICAVITY FLUORIDE WATERMELON FLAVORSODIUM FLUORIDEAshtel Studios, Inc.28d1b8c3-930f-4ac9-aa5a-b72b832bb77e2026-02-17WarningsExact identifier
application number: M021
Anticavity RinseSODIUM FLUORIDEValu Merchandisers Company088b95e6-30fd-4263-9fdc-57cd63385b712026-02-16Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEValu Merchandisers Companye31c1609-a1c3-4ed5-adfd-3cfa63205ec32026-02-16Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEUnited Natural Foods, Inc. dba UNFI3602c528-5f53-4d41-bf67-163149f52b352026-02-16Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEUnited Natural Foods, Inc. dba UNFIe696038c-182e-4325-9b90-87fe498d9f672026-02-16Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDETopco Associates LLC3b04142a-4a65-45ba-a5a2-e62b0c47ec552026-02-13Warnings, Adverse reactionsExact identifier
application number: M021
Mouth RinseSODIUM FLUORIDETopco Associates LLCc640adc0-e178-4b6a-af44-07d2f7da81d32026-02-13Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDETopco Associates LLCf760f8f8-0c74-4a6e-b5c9-cc82b8758a452026-02-13Warnings, Adverse reactionsExact identifier
application number: M021
Alcohol-Free AnticavitySODIUM FLUORIDETopco Associates LLCade7dcb2-b4e2-4cef-b9a7-469867ead68a2026-02-13Warnings, Adverse reactionsExact identifier
application number: M021
Oral AntivavitySODIUM FLUORIDETopco Associates LLC84b30711-a7e5-4189-895a-a7989f05591c2026-02-13Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity fluoride rinseSODIUM FLUORIDETopco Associates LLCc3f2e952-a8d5-4e9d-a5c6-09e4f25441792026-02-13Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDETopco Associates LLCa9b8b2fe-0a60-4f65-b6f6-aae8509c919f2026-02-13Warnings, Adverse reactionsExact identifier
application number: M021
SaliveaFLUORIDE TOOTHPASTELaclede, Inc.4abb0f80-d87d-730f-e063-6294a90a15f72026-02-13WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEYour Military Exchanges581d5cdb-018a-42ad-899d-5331f00633762026-02-12Warnings, Adverse reactionsExact identifier
application number: M021
Alcohol-Free AnticavitySODIUM FLUORIDEYour Military Exchanges965911c3-7aa8-4830-8269-6aa5d526ee732026-02-12Warnings, Adverse reactionsExact identifier
application number: M021
Mouth RinseSODIUM FLUORIDEWalgreen Co.eae87899-3eba-4d50-bc31-9eaf54ff9e002026-02-12Warnings, Adverse reactionsExact 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