FDA.reportPublic FDA data

Charm Tex Fluoride

Manufacturer
Yangzhou Hongshengding Chemical Co.,Ltd.
Effective date
2018-01-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:53:59

Label at a glance#

ProductCharm Tex Fluoride
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure8 sections

Dosage and administration

Adults and children 6 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 a physician. Children 2 to 6:Use only a pea sized amount and supervise child’s brushing and rinsing to minimize swallowing. Children under 2:Ask dentist or physician

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.76%(0.1%w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

helps protect against cavities

Warning

WARNINGS SECTION

Keep out of reach of children under 6 years of age.
If more than used for brushing is accidently swallowed get medical help or contact a poison control center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 6 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 a physician.
Children 2 to 6:Use only a pea sized amount and supervise child’s brushing and rinsing to minimize swallowing.
Children under 2:Ask dentist or physician

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Sorbitol, Silica, Methyl Paraben Sodium, Propyl Paraben Sodium, Sodium Saccharin, Flavour, Treated Water, SCMC,
Sodium Lauryl Sulfate

Keep out of reach of children under 6 years of age

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN2
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71035-200-012020-01-31C16284748780-19d75b9d0-c766-f424-e053-dadaa90a57ceTOOTHPASTE DRUG FACTS
71035-200-022020-01-31C16284748780-19d75b9d0-c766-f424-e053-dadaa90a57ceTOOTHPASTE DRUG FACTS
71035-200-032020-01-31C16284748780-19d75b9d0-c766-f424-e053-dadaa90a57ceTOOTHPASTE DRUG FACTS
71035-200-042020-01-31C16284748780-19d75b9d0-c766-f424-e053-dadaa90a57ceTOOTHPASTE DRUG FACTS
71035-200-052020-01-31C16284748780-19d75b9d0-c766-f424-e053-dadaa90a57ceTOOTHPASTE DRUG FACTS
71035-200-062020-01-31C16284748780-19d75b9d0-c766-f424-e053-dadaa90a57ceTOOTHPASTE DRUG FACTS
71035-200-072020-01-31C16284748780-19d75b9d0-c766-f424-e053-dadaa90a57ceTOOTHPASTE DRUG FACTS
71035-200-082020-01-31C16284748780-19d75b9d0-c766-f424-e053-dadaa90a57ceTOOTHPASTE DRUG FACTS
71035-200-092020-01-31C16284748780-19d75b9d0-c766-f424-e053-dadaa90a57ceTOOTHPASTE DRUG FACTS
71035-200-102020-01-31C16284748780-19d75b9d0-c766-f424-e053-dadaa90a57ceTOOTHPASTE DRUG FACTS
71035-200-112020-01-31C16284748780-19d75b9d0-c766-f424-e053-dadaa90a57ceTOOTHPASTE DRUG FACTS
71035-200-122020-01-31C16284748780-19d75b9d0-c766-f424-e053-dadaa90a57ceTOOTHPASTE DRUG FACTS
71035-200-132020-01-31C16284748780-19d75b9d0-c766-f424-e053-dadaa90a57ceTOOTHPASTE DRUG FACTS
71035-200-142020-01-31C16284748780-19d75b9d0-c766-f424-e053-dadaa90a57ceTOOTHPASTE DRUG FACTS
71035-200-152020-01-31C16284748780-19d75b9d0-c766-f424-e053-dadaa90a57ceTOOTHPASTE DRUG FACTS
71035-200-162020-01-31C16284748780-19d75b9d0-c766-f424-e053-dadaa90a57ceTOOTHPASTE DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71035-200-01Charm Tex Fluoride17 g in 1 TUBEPASTE172
71035-200-02Charm Tex Fluoride24 g in 1 TUBEPASTE242
71035-200-03Charm Tex Fluoride35 g in 1 TUBEPASTE352
71035-200-04Charm Tex Fluoride43 g in 1 TUBEPASTE432
71035-200-05Charm Tex Fluoride50 g in 1 TUBEPASTE502
71035-200-06Charm Tex Fluoride70 g in 1 TUBEPASTE702
71035-200-07Charm Tex Fluoride78 g in 1 TUBEPASTE782
71035-200-08Charm Tex Fluoride90 g in 1 TUBEPASTE902
71035-200-09Charm Tex Fluoride100 g in 1 TUBEPASTE1002
71035-200-10Charm Tex Fluoride120 g in 1 TUBEPASTE1202
71035-200-11Charm Tex Fluoride130 g in 1 TUBEPASTE1302
71035-200-12Charm Tex Fluoride150 g in 1 TUBEPASTE1502
71035-200-13Charm Tex Fluoride180 g in 1 TUBEPASTE1802
71035-200-14Charm Tex Fluoride3 g in 1 TUBEPASTE32
71035-200-15Charm Tex Fluoride5 g in 1 TUBEPASTE52
71035-200-16Charm Tex Fluoride10 g in 1 TUBEPASTE102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71035-200CHARM TEX FLUORIDE (SODIUM FLUORIDE) PASTE [YANGZHOU HONGSHENGDING CHEMICAL CO.,LTD.]2Legacy NDC, 16 package rows20180108_3f4d3a9f-b320-3f8e-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71035-20071035-200-01, 71035-200-02, 71035-200-03, 71035-200-04, 71035-200-05, 71035-200-06, 71035-200-07, 71035-200-08, 71035-200-09, 71035-200-10, 71035-200-11, 71035-200-12, 71035-200-13, 71035-200-14, 71035-200-15, 71035-200-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
SORBITOL506T60A25RIACT
SILICA DIMETHYL SILYLATEEU2PSP0G0WIACT
CALCIUM CARBONATEH0G9379FGKIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABEN SODIUM625NNB0G9NIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
WATER059QF0KO0RIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
SODIUM LAURYL SULFATE368GB5141JIACT
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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
62175f7d-6bea-2fb8-e053-2991aa0adb4b3f4d3a9f-b320-3f8e-e054-00144ff88e882018-01-06WarningsExact identifier
spl id: 62175f7d-6bea-2fb8-e053-2991aa0adb4b
spl set id: 3f4d3a9f-b320-3f8e-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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