FDA.reportPublic FDA data

10g Colgate plus Toothbrush Kit

Manufacturer
Colgate-Palmolive (Thailand) Limited - Branch
Effective date
2022-11-16
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:51:34

Label at a glance#

Product10g Colgate plus Toothbrush Kit
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure7 sections

Dosage and administration

 adults and children 2 years of age and older  brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician  children 2 to 6 years  use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)  children under 2 years  ask a dentist or physician 

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium monofluorophosphate 0.76% (0.15% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

helps protect against cavities

Warnings

WARNINGS SECTION

Keep out of the reach of children under 6 years of age.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

 adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
 children 2 to 6 years use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
 children under 2 years ask a dentist or physician 

Inactive ingredients

INACTIVE INGREDIENT SECTION

dicalcium phosphate dihydrate, water, sorbitol, sodium lauryl sulfate, flavor, cellulose gum, tetrasodium pyrophosphate, sodium saccharin

Questions or comments?

OTC - QUESTIONS SECTION

Call to-free 1-800-468-6502

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tooth Brush and Tube PhotoTooth Brush and Tube PhotoLabelLabelLabel2Label2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN6
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD6
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY6
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY6
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY6
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY6

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42555-001-012024-01-30C16284748780-11030e365-2d7b-111a-e063-dadaa90a10e210g Colgate + Toothbrush Kit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42555-001-0110g Colgate plus Toothbrush Kit1 in 1 KITKIT16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42555-00110G COLGATE PLUS TOOTHBRUSH KIT (SODIUM MONOFLUOROPHOSPHATE) KIT [COLGATE-PALMOLIVE (THAILAND) LIMITED - BRANCH]6Legacy NDC, 1 package rows20221117_56440ee5-b695-4cff-a598-47524136d097.zip
42555-06010G COLGATE PLUS TOOTHBRUSH KIT (SODIUM MONOFLUOROPHOSPHATE) KIT [COLGATE-PALMOLIVE (THAILAND) LIMITED - BRANCH]6Current NDC, Legacy NDC20221117_56440ee5-b695-4cff-a598-47524136d097.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42555-00142555-001-01
42555-06042555-060-45

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JIACT
WATER059QF0KO0RIACT
SODIUM LAURYL SULFATE368GB5141JIACT
METHYL SALICYLATELAV5U5022YIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
SODIUM PYROPHOSPHATEO352864B8ZIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM

Source Document#

Source XML

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 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colgate AnticavitySODIUM MONOFLUOROPHOSPHATEMING FAI ENTERPRISE (CAMBODIA) CO., LTD.4ba81636-cdb7-e904-e063-6394a90a8bd52026-02-25WarningsExact identifier
ndc (package): 42555-060-45
ndc11 (package): 42555006045
Colgate AnticavitySODIUM MONOFLUOROPHOSPHATEFORMIA LIMITED48ef2635-7157-4cd7-9f99-967f0143f7f12026-02-09WarningsExact identifier
ndc (package): 42555-060-45
ndc11 (package): 42555006045
Gracie Square Hospital AmenitySODIUM MONOFLUOROPHOSPHATEASP Global, LLc89d81053-6950-465e-a5b1-cbf841d7afcb2025-12-29WarningsExact identifier
ndc (package): 42555-060-45
ndc11 (package): 42555006045
Englewood Mesh AmenityBENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLca737fe63-6285-41ee-9516-9c3030a0ab482025-12-29WarningsExact identifier
ndc (package): 42555-060-45
ndc11 (package): 42555006045
NewYork-Presbyterian AmenitySODIUM MONOFLUOROPHOSPATEASP Global, LLc4b307471-445d-4c51-a499-d074a8172f202024-12-17WarningsExact identifier
ndc (package): 42555-060-45
ndc11 (package): 42555006045
Univ of Vermont Medical Center AmenityBENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLc7841cfa9-e94e-4c3d-b5fb-6769240178452024-12-17WarningsExact identifier
ndc (package): 42555-060-45
ndc11 (package): 42555006045
Northside Hospital Mothers VaginalALCOHOL AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLc7f1a85fd-086b-4fc7-abac-863dd3ea505a2024-12-17WarningsExact identifier
ndc (package): 42555-060-45
ndc11 (package): 42555006045
Northside Hospital H.E.A.R.T. Strings ToteALCOHOL AND SODIUM MONOFLUOROPHOSPATEASP Global, LLcf8369a27-1995-4fdd-a282-35c344c11d832024-12-17WarningsExact identifier
ndc (package): 42555-060-45
ndc11 (package): 42555006045
Northside Hospital Amenity KitALCOHOL AND SODIUM MONOFLUOROPHOSPATEASP Global, LLc877ce875-c5b0-4d9b-8f00-682914e3bc0e2024-12-17WarningsExact identifier
ndc (package): 42555-060-45
ndc11 (package): 42555006045
Wellstar AmenityBENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLcced9dd96-7922-43d7-906f-32afaad733ec2024-12-17WarningsExact identifier
ndc (package): 42555-060-45
ndc11 (package): 42555006045
Northside Hospital C-Section MothersALCOHOL AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLc9df6d0e9-631c-4619-9d96-d2c5a32a590e2024-12-17WarningsExact identifier
ndc (package): 42555-060-45
ndc11 (package): 42555006045
Memorial Sloan Kettering Cancer Center Amenity KitSODIUM MONOFLUOROPHOSPHATEASP Global, LLccab0bef1-f486-4eac-a61b-6030467d86502024-12-17WarningsExact identifier
ndc (package): 42555-060-45
ndc11 (package): 42555006045
Sarasota Memorial AmenityALCOHOL AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLcf5dda019-fcfd-4e99-89cc-e79e76b402e72024-12-17WarningsExact identifier
ndc (package): 42555-060-45
ndc11 (package): 42555006045
Englewood AmenityBENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLc7c9ce1bf-6aa2-4073-ad09-2ddf845102a22024-12-17WarningsExact identifier
ndc (package): 42555-060-45
ndc11 (package): 42555006045
Colgate AnticavitySODIUM MONOFLUOROPHOSPHATEColgate-Palmolive (Thailand) Limited - Branch5bc0b430-6f68-4e52-a1da-de19136eaeac2024-12-09WarningsExact identifier
ndc (package): 42555-060-45
ndc (product): 42555-060
ndc11 (package): 42555006045
Emory Johns Creek AmenityALCOHOL AND SODIUM MONOFLUOROPHOSPATEASP Global952ccb85-71bb-4d5d-ac9b-62851a39d36d2024-12-04WarningsExact identifier
ndc (package): 42555-060-45
ndc11 (package): 42555006045
ed9a649a-1acb-ec8a-e053-2a95a90a43da56440ee5-b695-4cff-a598-47524136d0972022-11-16WarningsExact identifier
spl id: ed9a649a-1acb-ec8a-e053-2a95a90a43da
spl set id: 56440ee5-b695-4cff-a598-47524136d097

Reported adverse events (FAERS/openFDA)#

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