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 42 of 49 · 974 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Morning FreshSODIUM FLUORIDEDynarex Corporation1d0457d7-0228-4ea3-9755-73bacd2201e62024-12-27WarningsExact identifier
application number: M021
Bubble Fresh Toothpaste, with FluorideBUBBLE FRESH TOOTHPASTE, WITH FLUORIDEDynarex Corporation2a2f5ed9-31ec-f6c8-e063-6394a90a44d62024-12-26WarningsExact identifier
application number: M021
Brush Buddies Crayola Swirl ANTICAVITY FLUORIDE WATERMELON FLAVORSODIUM FLUORIDEAshtel Studios, Inc.b3006c29-1f7f-4d9f-ab46-5a36df1a04712024-12-25WarningsExact identifier
application number: M021
Listerine Total Care Zero Alcohol Anticavity Fresh MintSODIUM FLUORIDEKenvue Brands LLC4b594a6e-db1d-443b-bfa7-23ee15749f472024-12-19WarningsExact identifier
application number: M021
NewYork-Presbyterian AmenitySODIUM MONOFLUOROPHOSPATEASP Global, LLc4b307471-445d-4c51-a499-d074a8172f202024-12-17WarningsExact identifier
application number: M021
Colgate AnticavitySODIUM MONOFLUOROPHOSPHATEColgate-Palmolive (Thailand) Limited - Branch5bc0b430-6f68-4e52-a1da-de19136eaeac2024-12-09WarningsExact identifier
application number: M021
CURODONT REPAIR FLUORIDE PLUSSODIUM FLUORIDECREDENTIS AG03ec09f9-4281-9ccb-e063-6294a90aadd82024-12-01WarningsExact identifier
application number: M021
CURODONT PROTECTSTANNOUS FLUORIDECREDENTIS AG03ec591c-68c3-a380-e063-6394a90a131a2024-12-01WarningsExact identifier
application number: M021
ACT Kids Anticavity Fluoride Bubble Gum BlowoutSODIUM FLUORIDEChattem, Inc.61f3a3e6-645b-4368-b1d5-7de1fc14542e2024-12-01WarningsExact identifier
application number: M021
SparkleFresh Flouride ToothpasteSODIUM MONOFLUOROPHOSPHATEMedline Industries, LP1565528b-89f2-4c97-b294-15b6ebd3f80e2024-11-26WarningsExact identifier
application number: M021
Rembrandt Intense StainSODIUM FLUORIDERanir LLC55dcd063-5661-35aa-e054-00144ff8d46c2024-11-26WarningsExact identifier
application number: M021
Firefly Anticavity FluorideSODIUM FLUORIDERanir LLC9f98913f-6754-4e1c-98cf-b89fe87750f82024-11-25WarningsExact identifier
application number: M021
Colgate Total SF Clean MintSTANNOUS FLUORIDEColgate-Palmolive Company88f87f7a-5b2d-47c9-8830-6b88b4ddbb592024-11-25WarningsExact identifier
application number: M021
Firefly Bubble Gum natural fluorideSODIUM FLUORIDERanir LLC0c85d273-3b98-43ea-81ba-c90f70ab72f82024-11-25WarningsExact identifier
application number: M021
Firefly Bubble Gum natural fluorideSODIUM FLUORIDERanir LLC2a882210-49e6-4b9c-a2c6-eaa37b6514c32024-11-25WarningsExact identifier
application number: M021
Pepsodent Complete Care OriginalSODIUM FLUORIDEChurch & Dwight Co., Inc.3c6931cb-0ec9-41bb-b410-c355573aab572024-11-21WarningsExact identifier
application number: M021
Firefly Strawberry Natural FluorideSODIUM FLUORIDERanir LLC8ee37955-fe1a-4964-ac29-d1d7dfb694cc2024-11-21WarningsExact identifier
application number: M021
Firefly Anticavity FluorideSODIUM FLUORIDERanir LLCabdc7f79-5f87-4307-8ddd-e6281ac67a042024-11-20WarningsExact identifier
application number: M021
AIM Bubble BerrySODIUM FLUORIDEChurch & Dwight Co., Inc.c83ccdea-d75f-4084-853e-ed4bab9a12d42024-11-20WarningsExact identifier
application number: M021
AIM TARTAR CONTROL Plus Mouthwash and WhiteningSODIUM FLUORIDEChurch & Dwight Co., Inc.1d0fc71c-d28e-4afa-e054-00144ff8d46c2024-11-20WarningsExact 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