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
Ingredient	Strength
SODIUM FLUORIDE	.95 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8ZYQ1474W7	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
786c6184-6bc8-4376-9ce2-3e35af193210	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
48878-3150-1	Clinpro Tooth Creme	1 in 1 BOX	PASTE, DENTIFRICE	1	9
48878-3150-1	Clinpro Tooth Creme	113 g in 1 TUBE	PASTE, DENTIFRICE	113	9
48878-3150-2	Clinpro Tooth Creme	1 in 1 BOX	PASTE, DENTIFRICE	1	9
48878-3150-2	Clinpro Tooth Creme	24 g in 1 TUBE	PASTE, DENTIFRICE	24	9
48878-3150-5	Clinpro Tooth Creme	90 g in 1 TUBE	PASTE, DENTIFRICE	90	9
48878-3150-5	Clinpro Tooth Creme	1 in 1 BOX	PASTE, DENTIFRICE	1	9
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 Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
sodium fluoride	ACTIVE INGREDIENT	8ZYQ1474W7	CLINPRO TOOTH CREME (SODIUM FLUORIDE) PASTE, DENTIFRICE [3M ESPE DENTAL PRODUCTS]	1
fluoride ion	ACTIVE MOIETY	Q80VPU408O	CLINPRO TOOTH CREME (SODIUM FLUORIDE) PASTE, DENTIFRICE [3M ESPE DENTAL PRODUCTS]	1
carboxymethylcellulose sodium	INACTIVE INGREDIENT	K679OBS311	CLINPRO TOOTH CREME (SODIUM FLUORIDE) PASTE, DENTIFRICE [3M ESPE DENTAL PRODUCTS]	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	CLINPRO TOOTH CREME (SODIUM FLUORIDE) PASTE, DENTIFRICE [3M ESPE DENTAL PRODUCTS]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	CLINPRO TOOTH CREME (SODIUM FLUORIDE) PASTE, DENTIFRICE [3M ESPE DENTAL PRODUCTS]	1
saccharin sodium	INACTIVE INGREDIENT	SB8ZUX40TY	CLINPRO TOOTH CREME (SODIUM FLUORIDE) PASTE, DENTIFRICE [3M ESPE DENTAL PRODUCTS]	1
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	CLINPRO TOOTH CREME (SODIUM FLUORIDE) PASTE, DENTIFRICE [3M ESPE DENTAL PRODUCTS]	1
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	CLINPRO TOOTH CREME (SODIUM FLUORIDE) PASTE, DENTIFRICE [3M ESPE DENTAL PRODUCTS]	1
sorbitol	INACTIVE INGREDIENT	506T60A25R	CLINPRO TOOTH CREME (SODIUM FLUORIDE) PASTE, DENTIFRICE [3M ESPE DENTAL PRODUCTS]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	CLINPRO TOOTH CREME (SODIUM FLUORIDE) PASTE, DENTIFRICE [3M ESPE DENTAL PRODUCTS]	1
tricalcium phosphate	INACTIVE INGREDIENT	K4C08XP666	CLINPRO TOOTH CREME (SODIUM FLUORIDE) PASTE, DENTIFRICE [3M ESPE DENTAL PRODUCTS]	1
water	INACTIVE INGREDIENT	059QF0KO0R	CLINPRO TOOTH CREME (SODIUM FLUORIDE) PASTE, DENTIFRICE [3M ESPE DENTAL PRODUCTS]	1

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]	9	Current NDC, Legacy NDC, 6 package rows	20240807_5b85a10c-90ec-4148-849f-0e9f694530aa.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

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 47 of 49 · 974 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EUTHYMOL Extraordinary Pink Whitening	SODIUM FLUORIDE	LG H&H CO., LTD.	13910b55-9b5d-af53-e063-6294a90acf5d	2024-03-13	Warnings	Exact identifier application number: M021
BIO SPECTRA ATTITUDE	SODIUM FLUORIDE	9055-7588 Quebec Inc. DBA Attitude	e3bb60f8-2a06-42d6-a182-8c31bb982a2a	2024-03-01	Warnings	Exact identifier application number: M021
Maximum Security	SODIUM FLUORIDE	Bob Barker Company Inc.	e29f30ec-72ea-4944-a2c2-b1696d31b639	2024-02-27	Warnings	Exact identifier application number: M021
Made by Dentists For Kids Monster Slime Sour Apple	SODIUM FLUORIDE	MADE BY DENTISTS INC	dfddc67c-3626-48c4-8120-bcc6c455d119	2024-02-23	Warnings	Exact identifier application number: M021
Orajel Gabbys Dollhouse	SODIUM FLUORIDE	Church & Dwight Co., Inc.	cd47bd1e-44ac-465f-8529-6073ade14706	2024-02-23	Warnings	Exact identifier application number: M021
Colgate Kids Maximum Cavity Protection	SODIUM FLUORIDE	Colgate-Palmolive	c44c7a7e-fc3e-a81b-1961-ff89614b678f	2024-02-22	Warnings	Exact identifier application number: M021
TheraBreath Fresh Breath Anticavity Mild Mint	SODIUM FLUORIDE	Church & Dwight Co., Inc.	19ce5324-7d8d-4d70-ad9b-238f7e612eac	2024-02-06	Warnings	Exact identifier application number: M021
Nature Mint Anticavity	SODIUM MONOFLUOROPHOSPHATE	Bob Barker Company Inc.	916891d3-5234-46a8-a492-21a31f36a852	2024-02-02	Warnings	Exact identifier application number: M021
Treatment Rinse Mint	ANTICARIES	DENTAL ALLIANCE HOLDINGS LLC	f1255065-b7c3-4eb6-e053-2995a90afcdb	2024-01-31	Warnings	Exact identifier application number: M021
Maintenance Rinse Mint	ANTICARIES	Dental Alliance Holdings LLC	f1273510-aa83-3ef9-e053-2a95a90aea27	2024-01-31	Warnings	Exact identifier application number: M021
ATOMY PROPOLIS TOOTHPAS TE 50G	SODIUM MONOFLUOROPHOSPHATE, SODIUM FLUORIDE	ATOMY CO., LTD.	98d839e3-a1aa-c83d-e053-2995a90a7e79	2024-01-30	Warnings	Exact identifier application number: M021
ATOMY PROPOLIS TOOTHPAS TE 200G	SODIUM MONOFLUOROPHOSPHATE, SODIUM FLUORIDE	ATOMY CO., LTD.	98aebbec-aec0-1478-e053-2a95a90a03ea	2024-01-30	Warnings	Exact identifier application number: M021
Toms Childrens Anticavity Mouthwash Silly Strawberry	SODIUM FLUORIDE	Tom's of Maine, Inc.	998c6f35-20f4-4cb8-bc48-6aa39e61481a	2024-01-18	Warnings	Exact identifier application number: M021
Gel-Kam Fruit and Berry	STANNOUS FLUORIDE	Colgate Oral Pharmaceuticals, Inc.	8c2c3c5c-ddef-4a4d-8bc3-5a98c577e74c	2024-01-18	Warnings	Exact identifier application number: M021
Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Gushing Grape Fluoride	SODIUM FLUORIDE	Colgate Oral Pharmaceuticals, Inc.	9a976ac8-d966-4d94-93da-45652f2d2481	2024-01-12	Warnings	Exact identifier application number: M021
Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Mint Fluoride	SODIUM FLUORIDE	Colgate Oral Pharmaceuticals, Inc.	2b4b6f9a-0e31-4891-8721-d1b9a58cca96	2024-01-12	Warnings	Exact identifier application number: M021
Colgate MaxFresh with Mini Breath Cool Mint	SODIUM FLUORIDE	Colgate-Palmolive Company	51abd6bc-7a3d-4b0e-a810-af9e94926438	2024-01-09	Warnings	Exact identifier application number: M021
Colgate Enamel Strength Mouthwash	SODIUM FLUORIDE	Colgate-Palmolive - do not use	f0cca38b-c0a3-4788-8cca-727a5684c16b	2024-01-09	Warnings	Exact identifier application number: M021
PerCara Oral Health Rinse Fresh Mint	CETYLPYRIDINIUM CHLORIDE	LEC Custom Products, Inc	bd98c654-218b-15ac-e053-2a95a90a75d1	2024-01-01	Warnings	Exact identifier application number: M021
PerCara Kids Bubble Gum	SODIUM FLUORIDE	LEC Custom Products, Inc.	be3a7272-acfb-7d14-e053-2995a90a9420	2024-01-01	Warnings	Exact identifier application number: M021

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8ZYQ1474W7	SODIUM FLUORIDE	7681-49-4	SODIUM FLUORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1099038	sodium fluoride 0.21 % Toothpaste	PSN	5b85a10c-90ec-4148-849f-0e9f694530aa	9
1099038	sodium fluoride 0.0021 MG/MG Toothpaste	SCD	5b85a10c-90ec-4148-849f-0e9f694530aa	9
1099038	sodium fluoride 0.21 % Toothpaste	SY	5b85a10c-90ec-4148-849f-0e9f694530aa	9
1099038	sodium fluoride 0.21 % Toothpaste	PSN	786c6184-6bc8-4376-9ce2-3e35af193210	7
1099038	sodium fluoride 0.0021 MG/MG Toothpaste	SCD	786c6184-6bc8-4376-9ce2-3e35af193210	7
1099038	sodium fluoride 0.21 % Toothpaste	SY	786c6184-6bc8-4376-9ce2-3e35af193210	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
48878-3150-1	48878315001	1 in 1 BOX						Historical
48878-3150-2	48878315002	1 in 1 BOX						Historical
48878-3150-4	48878315004	1 TUBE in 1 BOX (48878-3150-4) / 113 g in 1 TUBE	1 tube	2013-07-18	0000-00-00	No	No	Current
48878-3150-5	48878315005	90 g in 1 TUBE	90 g					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clinpro Tooth Creme - Solventum US LLC \| Sheffield Pharmaceuticals LLC	Solventum US LLC \| Sheffield Pharmaceuticals LLC	2024-08-01	HUMAN OTC DRUG LABEL	9
Clinpro Tooth Creme - Solventum US LLC	Solventum US LLC	2024-08-01	HUMAN OTC DRUG LABEL	7