FDA.reportPublic FDA data

sodium fluoride 0.011 MG/MG Toothpaste [Clinpro 5000]

RxCUI
1006558
RxNorm name
sodium fluoride 0.011 MG/MG Toothpaste [Clinpro 5000]
Display name
CLINPRO 5000 (Toothpaste)
Full name
sodium fluoride 0.011 MG/MG Toothpaste [Clinpro 5000]
Term type
SBD
Status
Active
Strength
1.1%
Dose form
Toothpaste
Route
Toothpaste
Updated
2026-10-24 12:25:21

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
092010
Active start
092010
Multiple ingredient
NO
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
sodium fluoride0.011 MG / 1 MGsodium fluoridesodium fluoride

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Toothpaste10652

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
sodium fluoride9873

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRClinpro 5000 1.1 % Toothpaste1NAMES
RxNorm Namesodium fluoride 0.011 MG/MG Toothpaste [Clinpro 5000]1NAMES
RxNorm Synonym
2 linked values
2NAMES
TTYSBD1ATTRIBUTES
SPL_SET_ID
3 linked values
3CODES
RxCUI10065581CODES
MMSL_CODEBD69371CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
48878-3120-448878-3120Clinpro 5000 sodium fluorideSolventum US LLC
48878-3130-448878-3130Clinpro 5000 sodium fluorideSolventum US LLC
48878-3140-448878-3140Clinpro 5000 sodium fluorideSolventum US LLC

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 4 matching rows.

NDC11, Source, Active table
NDC11SourceActive
48878312004rxnav_ndcsyes
48878313004rxnav_ndcsyes
48878314004rxnav_ndcsyes
48878313001rxnav_historical

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clinpro 5000SODIUM FLUORIDESolventum US LLCa20d3cf0-2e1f-4191-971e-9e47936b45802024-08-01Warnings, Adverse reactionsExact identifier
ndc (package): 48878-3120-4
ndc (package): 48878-3130-4
ndc (package): 48878-3140-4
ndc (product): 48878-3120
ndc (product): 48878-3140
ndc (product): 48878-3130
ndc11 (package): 48878314004
ndc11 (package): 48878313004
ndc11 (package): 48878312004
rxcui: 1006558

Reported adverse events (FAERS/openFDA)#

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

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 3 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
a20d3cf0-2e1f-4191-971e-9e47936b4580Clinpro 5000 1.1 % Toothpaste [PSN] · sodium fluoride 0.011 MG/MG Toothpaste [Clinpro 5000] [SBD] · Clinpro 5000 0.011 MG/MG Toothpaste [SY] · Clinpro 5000 1.1 % Toothpaste [SY]49These highlights do not include all the information needed to use 3M TM ESPE TM Clinpro TM 5000 Anti-Cavity Toothpaste safely and effectively. See full prescribing information for Clinpro 5000 Anti-Cavity Toothpaste. 3M TM ESPE TM Clinpro 5000 1.1% Sodium Fluoride Anti-Cavity Toothpaste for oral use. Initial U.S. Approval: None20240801
f982709b-c486-43a8-b17c-6957092e8f3cClinpro 5000 1.1 % Toothpaste [PSN] · sodium fluoride 0.011 MG/MG Toothpaste [Clinpro 5000] [SBD] · Clinpro 5000 0.011 MG/MG Toothpaste [SY] · Clinpro 5000 1.1 % Toothpaste [SY]4620240801
bc28f99c-49a5-44e4-a045-63831625f884Clinpro 5000 1.1 % Toothpaste [PSN] · sodium fluoride 0.011 MG/MG Toothpaste [Clinpro 5000] [SBD] · Clinpro 5000 0.011 MG/MG Toothpaste [SY] · Clinpro 5000 1.1 % Toothpaste [SY]4420240801

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
a20d3cf0-2e1f-4191-971e-9e47936b4580These highlights do not include all the information needed to use 3M TM ESPE TM Clinpro TM 5000 Anti-Cavity Toothpaste safely and effectively. See full prescribing information for Clinpro 5000 Anti-Cavity Toothpaste. 3M TM ESPE TM Clinpro 5000 1.1% Sodium Fluoride Anti-Cavity Toothpaste for oral use. Initial U.S. Approval: NoneSolventum US LLC20240801
bc28f99c-49a5-44e4-a045-63831625f884Solventum US LLC20240801
84a4a8af-fbcc-4e6c-b1e7-6ef54b0f195dNational Council for Prescription Drug Programs20130213

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCA01AACaries prophylactic agentsATC1-4sodium fluoride
ATCA12CDFluorideATC1-4sodium fluoride
MEDRTD012969Sodium FluorideCHEMhas_ingredientsodium fluoride
MEDRTD003731Dental CariesDISEASEmay_preventsodium fluoride
MEDRTD003773Dental PlaqueDISEASEmay_preventsodium fluoride
MEDRTD004342Drug HypersensitivityDISEASEci_withsodium fluoride
MEDRTD010024OsteoporosisDISEASEmay_treatsodium fluoride
MEDRTD016388Tooth LossDISEASEmay_preventsodium fluoride
MEDRTN0000009915Unknown Cellular or Molecular InteractionMOAhas_moasodium fluoride
MEDRTN0000008311Bone Formation StimulationPEhas_pesodium fluoride

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH0.011 MG/MG
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
NAMESPrescribable SynonymClinpro 5000 1.1 % Toothpaste
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon