Clinpro Tooth Creme

Manufacturer: Solventum US LLC
Effective date: 2024-08-01
Label type: HUMAN OTC DRUG LABEL
Version: 7
Source: full-release
Hydrated at: 2026-06-01 00:16:41

Label at a glance#

ProductClinpro Tooth Creme

Active ingredientsodium fluoride

Label structure8 sections

Dosage and administration

adults and children 2 yrs. & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist do not swallow to minimize swallowing, use a pea-sized amount in children under 6 supervise children's brushing until good habits are established children under 2 years, ask your dentist

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.21% (0.12% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity Toothpaste

Use

INDICATIONS & USAGE SECTION

helps protect teeth and roots against cavities

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 2 yrs. & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist
do not swallow
to minimize swallowing, use a pea-sized amount in children under 6
supervise children's brushing until good habits are established
children under 2 years, ask your dentist

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, sorbitol, hydrated silica, glycerin, polyethylene-polypropylene glycol, flavor, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, carboxymethyl cellulose, sodium saccharin, tri-calcium phoshate

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 48878-3150-4

3M ESPE

Clinpro™ Tooth Crème

Vanilla Mint

0.21% Sodium Flouride
Anti-Cavity Toothpaste

Contents: 1 Tube NET WT 4 oz (113 g)

Principal Display Panel - Clinpro Tooth Creme

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1099038	sodium fluoride 0.21 % Toothpaste	PSN	7
1099038	sodium fluoride 0.0021 MG/MG Toothpaste	SCD	7
1099038	sodium fluoride 0.21 % Toothpaste	SY	7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
48878-3150-4	Clinpro Tooth Creme	1 in 1 BOX	PASTE, DENTIFRICE	1		7
48878-3150-4	Clinpro Tooth Creme	113 g in 1 TUBE	PASTE, DENTIFRICE	113		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
48878-3150	CLINPRO TOOTH CREME (SODIUM FLUORIDE) PASTE, DENTIFRICE [SOLVENTUM US LLC]	7	Current NDC, Legacy NDC, 2 package rows	20240807_786c6184-6bc8-4376-9ce2-3e35af193210.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
sodium fluoride	ACTIVE INGREDIENT	8ZYQ1474W7	1
fluoride ion	ACTIVE MOIETY	Q80VPU408O	1
carboxymethylcellulose sodium	INACTIVE INGREDIENT	K679OBS311	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	1
saccharin sodium	INACTIVE INGREDIENT	SB8ZUX40TY	1
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	1
sorbitol	INACTIVE INGREDIENT	506T60A25R	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	1
tricalcium phosphate	INACTIVE INGREDIENT	K4C08XP666	1
water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

Clinpro Tooth Creme
sodium fluoride
Fluoride Ion
Water
Sorbitol
Silicon Dioxide
Glycerin
Polyethylene Glycol, Unspecified
Sodium Lauryl Sulfate
Titanium Dioxide
Carboxymethylcellulose Sodium
Saccharin Sodium
Tricalcium Phosphate

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
48878-3150	48878-3150-4

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
sodium fluoride	8ZYQ1474W7	ACTIM
Water	059QF0KO0R	IACT
Sorbitol	506T60A25R	IACT
Silicon Dioxide	ETJ7Z6XBU4	IACT
Glycerin	PDC6A3C0OX	IACT
Polyethylene Glycol, Unspecified	3WJQ0SDW1A	IACT
Sodium Lauryl Sulfate	368GB5141J	IACT
Titanium Dioxide	15FIX9V2JP	IACT
Carboxymethylcellulose Sodium	K679OBS311	IACT
Saccharin Sodium	SB8ZUX40TY	IACT
Tricalcium Phosphate	K4C08XP666	IACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 316 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	PASTE, DENTIFRICE / DENTAL	0.2 %w/w		Exact identifier — unii+dosage form 36 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / ORAL		665 mg	Exact identifier — unii+route 36 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	POWDER, FOR SOLUTION / ORAL		199 mg	Exact identifier — unii+route 36 equally ranked IID candidates
carboxymethylcellulose sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	TABLET, CHEWABLE / ORAL	24.75 mg		Exact identifier — unii+route 38 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE / ORAL	5000 mg		Exact identifier — unii+route 68 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	ELIXIR / ORAL		5621 mg	Exact identifier — unii+route 42 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	PASTE, DENTIFRICE / DENTAL	0.2 %w/w		Exact identifier — unii+dosage form 36 equally ranked IID candidates
sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	PASTE, DENTIFRICE / DENTAL	1.4 %w/w		Exact identifier — unii+dosage form 48 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION, EXTENDED RELEASE / ORAL		2000 mg	Exact identifier — unii+route 42 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	TABLET, FILM COATED / ORAL	5 mg		Exact identifier — unii+route 38 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION, CONCENTRATE / ORAL	200 mg/1ml		Exact identifier — unii+route 42 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii+route 68 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED / ORAL		166 mg	Exact identifier — unii+route 68 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	ELIXIR / ORAL	15 mg/5ml		Exact identifier — unii+route 36 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE / ORAL		55 mg	Exact identifier — unii+route 46 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	DROPS / ORAL	NA		Exact identifier — unii+route 68 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	SOLUTION / ORAL		29268 mg	Exact identifier — unii+route 38 equally ranked IID candidates
sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, DELAYED RELEASE PELLETS / ORAL		99 mg	Exact identifier — unii+route 48 equally ranked IID candidates
saccharin sodium	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, FILM COATED / ORAL	2 mg		Exact identifier — unii+route 36 equally ranked IID candidates
sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	TABLET, FILM COATED / ORAL		240 mg	Exact identifier — unii+route 48 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	POWDER, FOR SUSPENSION / ORAL		297 mg	Exact identifier — unii+route 46 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	DROPS / ORAL	300 mg/1ml		Exact identifier — unii+route 42 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	PASTE, DENTIFRICE / DENTAL	18 %w/w		Exact identifier — unii+dosage form 42 equally ranked IID candidates
carboxymethylcellulose sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	TABLET, FILM COATED / ORAL	50 mg		Exact identifier — unii+route 38 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	TABLET / ORAL		42 mg	Exact identifier — unii+route 42 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL		750 mg	Exact identifier — unii+route 68 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, DELAYED RELEASE PARTICLES / ORAL		170 mg	Exact identifier — unii+route 68 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, LIQUID FILLED / ORAL		12 mg	Exact identifier — unii+route 46 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 68 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	TABLET / ORAL	337.28 mg		Exact identifier — unii+route 38 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION, EXTENDED RELEASE / ORAL		2000 mg	Exact identifier — unii+route 42 equally ranked IID candidates
sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE / ORAL		600 mg	Exact identifier — unii+route 48 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	ELIXIR / ORAL	833.3 mg		Exact identifier — unii+route 38 equally ranked IID candidates
sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	TABLET, DELAYED RELEASE / ORAL		199 mg	Exact identifier — unii+route 48 equally ranked IID candidates
sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	TABLET, EXTENDED RELEASE / ORAL		320 mg	Exact identifier — unii+route 48 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 46 equally ranked IID candidates
sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, EXTENDED RELEASE / ORAL		166 mg	Exact identifier — unii+route 48 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	TABLET, COATED / ORAL	12.96 mg		Exact identifier — unii+route 38 equally ranked IID candidates
carboxymethylcellulose sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	TABLET, COATED / ORAL	3.2 mg		Exact identifier — unii+route 38 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	TABLET / ORAL	337.28 mg		Exact identifier — unii+route 38 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	TABLET, FILM COATED / ORAL	5 mg		Exact identifier — unii+route 38 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER, FOR SOLUTION / ORAL		280 mg	Exact identifier — unii+route 68 equally ranked IID candidates
carboxymethylcellulose sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	SOLUTION / ORAL		3480 mg	Exact identifier — unii+route 38 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SYRUP / ORAL		16734 mg	Exact identifier — unii+route 42 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	DROPS / ORAL	NA		Exact identifier — unii+route 46 equally ranked IID candidates
carboxymethylcellulose sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	GRANULE, FOR SUSPENSION / ORAL	15.63 mg/5ml		Exact identifier — unii+route 38 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	SUSPENSION / ORAL		113 mg	Exact identifier — unii+route 46 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		42 mg	Exact identifier — unii+route 46 equally ranked IID candidates
carboxymethylcellulose sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		100 mg	Exact identifier — unii+route 38 equally ranked IID candidates
carboxymethylcellulose sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	GRANULE / ORAL	NA		Exact identifier — unii+route 38 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		336 mg	Exact identifier — unii+route 68 equally ranked IID candidates
sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE / ORAL		600 mg	Exact identifier — unii+route 48 equally ranked IID candidates
sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	TABLET, EXTENDED RELEASE / ORAL		320 mg	Exact identifier — unii+route 48 equally ranked IID candidates
carboxymethylcellulose sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	POWDER, FOR SOLUTION / ORAL		161 mg	Exact identifier — unii+route 38 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	FILM, SOLUBLE / ORAL		2 mg	Exact identifier — unii+route 68 equally ranked IID candidates
sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	POWDER, FOR SUSPENSION / ORAL		64 mg	Exact identifier — unii+route 48 equally ranked IID candidates
carboxymethylcellulose sodium	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	SUSPENSION / ORAL		1080 mg	Exact identifier — unii+route 38 equally ranked IID candidates
sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 48 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, LIQUID FILLED / ORAL		12 mg	Exact identifier — unii+route 46 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	DROPS / ORAL	NA		Exact identifier — unii+route 46 equally ranked IID candidates

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clinpro Tooth Creme	SODIUM FLUORIDE	Solventum US LLC	786c6184-6bc8-4376-9ce2-3e35af193210	2024-08-01	Warnings	Exact identifier ndc (package): 48878-3150-4 ndc (product): 48878-3150 ndc11 (package): 48878315004 spl id: 8908ee6d-3159-423d-bba3-502931790708 spl set id: 786c6184-6bc8-4376-9ce2-3e35af193210

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.