Colgate 5g and Toothbrush Dental Kit

Manufacturer
FORMIA LIMITED
Effective date
2026-01-28
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:35:19

Label at a glance#

ProductColgate 5g and Toothbrush Dental Kit
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure8 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 doctor. Instruct children under 6 years of age in good brushing and rinising habits (to minimize swallowing). Supervuse children as necessary until capable of using without supervision. Children under 6 years of age: Consult a dentist or doctor.

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

Aids in the prevention of dental caries

Warning

WARNINGS SECTION

Keep out of reach of children.

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 doctor. Instruct children under 6 years of age in good brushing and rinising habits (to minimize swallowing). Supervuse children as necessary until capable of using without supervision.
  • Children under 6 years of age: Consult a dentist or doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

1-800-468-6502

Package Labeling:Kit

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

Package Labeling:5g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

22

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN7
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD7
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY7
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY7
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY7
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY7

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79940-004-002025-06-23C16284748780-12cef2736-66d9-d83d-e063-dadaa90ab31fColgate 5g Toothpaste and Toothbrush Dental Kit
79940-004-002025-01-30C16284748780-12cef2736-66d9-d83d-e063-dadaa90ab31fColgate 5g Toothpaste and Toothbrush Dental Kit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79940-004-00Colgate 5g and Toothbrush Dental Kit1 in 1 KITKIT17

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79940-00479940-004-00
79940-00579940-005-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colgate 5g and Toothbrush Dental KitSODIUM MONOFLUOROPHOSPHATEFORMIA LIMITED0b269f9a-aa3f-47b5-b7e8-59a5ed0e2b132026-01-28WarningsExact identifier
ndc (package): 79940-004-00
ndc (package): 79940-005-05
ndc (product): 79940-004
ndc11 (package): 79940000400
ndc11 (package): 79940000505
spl id: 49788a32-5f1f-5e36-e063-6294a90a2f85
spl set id: 0b269f9a-aa3f-47b5-b7e8-59a5ed0e2b13

Reported adverse events (FAERS/openFDA)#

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