FDA.reportPublic FDA data

Crest 24g and Toothbrush Dental kit

Manufacturer
Formia Airline Supplies Limited | The Procter & Gamble Manufacturing Company | Lianjiang Xiangheng Travel Bag Co.,Ltd.
Effective date
2023-10-31
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:58:31

Label at a glance#

ProductCrest 24g and Toothbrush Dental kit
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 dentist-directed 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 yrs: ask a dentist

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.243% (0.16% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Acticavity

Use

INDICATIONS & USAGE SECTION

toothpate helps protect against cavities

Warning

WARNINGS SECTION

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

under 6 yrs. of age. 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 yrs. & older: brush teeth thoroughly after meals or at least twice a day or use as dentist-directed
  • 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 yrs: ask a dentist

Inactive Ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrated silica, sodium hexametaphosphate, water, PEG-6, flavor, trisodium phosphate, sodium lauryl sulfate, carrageenan, cocamidopropyl betaine, sodium saccharin, PEG-20M, xanthan gum, sucralose, mica, titanium dioxide

Product Questions?

OTC - QUESTIONS SECTION

1-800-492-7378

Package Labeling: Kit

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

KIT label3KIT label3

Package Labeling:24g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tube3Tube3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
891775sodium fluoride 0.243 % ToothpastePSN4
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD4
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY4
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY4
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY4
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79940-007-002025-01-30C16284748780-12cef2736-708f-d83d-e063-dadaa90ab31fCrest 24g Toothpaste and Toothbrush Dental kit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79940-007-00Crest 24g and Toothbrush Dental kit1 in 1 KITKIT14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79940-007CREST 24G AND TOOTHBRUSH DENTAL KIT (SODIUM FLUORIDE) KIT [FORMIA AIRLINE SUPPLIES LIMITED]4Legacy NDC, 1 package rows20231101_21a34ff4-84ae-43d4-9215-884e7cc340b7.zip
79940-008CREST 24G AND TOOTHBRUSH DENTAL KIT (SODIUM FLUORIDE) KIT [FORMIA AIRLINE SUPPLIES LIMITED]4Unmatched20231101_21a34ff4-84ae-43d4-9215-884e7cc340b7.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79940-00779940-007-00
79940-00879940-008-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
HYDRATED SILICAY6O7T4G8P9IACT
HEXASODIUM HEXAMETAPHOSPHATEN40N91DW96IACT
WATER059QF0KO0RIACT
POLYETHYLENE GLYCOL 3005655G9Y8AQIACT
METHYL SALICYLATELAV5U5022YIACT
SODIUM LAURYL SULFATE368GB5141JIACT
CARRAGEENAN5C69YCD2YJIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
POLYETHYLENE OXIDE 90000016P9295IILIACT
XANTHAN GUMTTV12P4NEEIACT
SUCRALOSE96K6UQ3ZD4IACT
MICAV8A1AW0880IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM

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
090604b0-2c76-8f1c-e063-6294a90a2fe721a34ff4-84ae-43d4-9215-884e7cc340b72023-10-31WarningsExact identifier
spl id: 090604b0-2c76-8f1c-e063-6294a90a2fe7
spl set id: 21a34ff4-84ae-43d4-9215-884e7cc340b7

Reported adverse events (FAERS/openFDA)#

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