Charm Tex Fluoride

Manufacturer
Yangzhou Hengyuan Daily Chemical Plastic Co., Ltd.
Effective date
2013-07-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:36:02

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

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN1
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51289-200-012019-11-27C16284748780-19855d018-df61-cd31-e053-dbdaa90ab51aTOOTHPASTE DRUG FACTS
51289-200-022019-11-27C16284748780-19855d018-df61-cd31-e053-dbdaa90ab51aTOOTHPASTE DRUG FACTS
51289-200-032019-11-27C16284748780-19855d018-df61-cd31-e053-dbdaa90ab51aTOOTHPASTE DRUG FACTS
51289-200-042019-11-27C16284748780-19855d018-df61-cd31-e053-dbdaa90ab51aTOOTHPASTE DRUG FACTS
51289-200-052019-11-27C16284748780-19855d018-df61-cd31-e053-dbdaa90ab51aTOOTHPASTE DRUG FACTS
51289-200-062019-11-27C16284748780-19855d018-df61-cd31-e053-dbdaa90ab51aTOOTHPASTE DRUG FACTS
51289-200-072019-11-27C16284748780-19855d018-df61-cd31-e053-dbdaa90ab51aTOOTHPASTE DRUG FACTS
51289-200-082019-11-27C16284748780-19855d018-df61-cd31-e053-dbdaa90ab51aTOOTHPASTE DRUG FACTS
51289-200-092019-11-27C16284748780-19855d018-df61-cd31-e053-dbdaa90ab51aTOOTHPASTE DRUG FACTS
51289-200-102019-11-27C16284748780-19855d018-df61-cd31-e053-dbdaa90ab51aTOOTHPASTE DRUG FACTS
51289-200-112019-11-27C16284748780-19855d018-df61-cd31-e053-dbdaa90ab51aTOOTHPASTE DRUG FACTS
51289-200-122019-11-27C16284748780-19855d018-df61-cd31-e053-dbdaa90ab51aTOOTHPASTE DRUG FACTS
51289-200-132019-11-27C16284748780-19855d018-df61-cd31-e053-dbdaa90ab51aTOOTHPASTE DRUG FACTS
51289-200-142019-11-27C16284748780-19855d018-df61-cd31-e053-dbdaa90ab51aTOOTHPASTE DRUG FACTS
51289-200-152019-11-27C16284748780-19855d018-df61-cd31-e053-dbdaa90ab51aTOOTHPASTE DRUG FACTS
51289-200-162019-11-27C16284748780-19855d018-df61-cd31-e053-dbdaa90ab51aTOOTHPASTE DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51289-200-01Charm Tex Fluoride17 g in 1 TUBEPASTE171
51289-200-02Charm Tex Fluoride24 g in 1 TUBEPASTE241
51289-200-03Charm Tex Fluoride35 g in 1 TUBEPASTE351
51289-200-04Charm Tex Fluoride43 g in 1 TUBEPASTE431
51289-200-05Charm Tex Fluoride50 g in 1 TUBEPASTE501
51289-200-06Charm Tex Fluoride70 g in 1 TUBEPASTE701
51289-200-07Charm Tex Fluoride78 g in 1 TUBEPASTE781
51289-200-08Charm Tex Fluoride90 g in 1 TUBEPASTE901
51289-200-09Charm Tex Fluoride100 g in 1 TUBEPASTE1001
51289-200-10Charm Tex Fluoride120 g in 1 TUBEPASTE1201
51289-200-11Charm Tex Fluoride130 g in 1 TUBEPASTE1301
51289-200-12Charm Tex Fluoride150 g in 1 TUBEPASTE1501
51289-200-13Charm Tex Fluoride180 g in 1 TUBEPASTE1801
51289-200-14Charm Tex Fluoride3 g in 1 TUBEPASTE31
51289-200-15Charm Tex Fluoride5 g in 1 TUBEPASTE51
51289-200-16Charm Tex Fluoride10 g in 1 TUBEPASTE101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51289-200CHARM TEX FLUORIDE (SODIUM FLUORIDE) PASTE [YANGZHOU HENGYUAN DAILY CHEMICAL PLASTIC CO., LTD.]1Legacy NDC, 16 package rows20130710_c7acded8-16ea-4e4f-802e-7a75d3086d31.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SODIUM MONOFLUOROPHOSPHATEACTIVE INGREDIENTC810JCZ56Q1
FLUORIDE IONACTIVE MOIETYQ80VPU408O1
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGK1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS3111
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
PROPYLPARABEN SODIUMINACTIVE INGREDIENT625NNB0G9N1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TY1
SILICA DIMETHYL SILYLATEINACTIVE INGREDIENTEU2PSP0G0W1
Sodium Lauryl SulfateINACTIVE INGREDIENT368GB5141J1
SorbitolINACTIVE INGREDIENT506T60A25R1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

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

NDC Codes#

Ingredients#

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

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

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 271 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYINJECTION / INTRAVENOUS22 mgExact identifier — unii candidate
34 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311INJECTION, SUSPENSION / SOFT TISSUE15 mgExact identifier — unii candidate
44 equally ranked IID candidates
SorbitolSORBITOL506T60A25RINJECTION, SOLUTION / SUBCUTANEOUS4.7 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCONCENTRATE / ORAL12 mgExact identifier — unii candidate
79 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311CREAM / VAGINAL0.75 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYOINTMENT / TOPICALNAExact identifier — unii candidate
34 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYPASTE / ORAL3 mgExact identifier — unii candidate
34 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SUSPENSION/ DROPS / ORAL12.85 mg/2.5mlExact identifier — unii candidate
44 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET / SUBLINGUAL7 mgExact identifier — unii candidate
34 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSHAMPOO, SUSPENSION / TOPICAL0.15 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
SorbitolSORBITOL506T60A25RPASTE, DENTIFRICE / DENTAL14 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
SILICA DIMETHYL SILYLATESILICA DIMETHYL SILYLATEEU2PSP0G0WTABLET, FILM COATED / ORAL2 mgExact identifier — unii candidate
7 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUSPENSION/ DROPS / OPHTHALMIC0.05 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
Sodium Lauryl SulfateSODIUM LAURYL SULFATE368GB5141JCAPSULE, EXTENDED RELEASE / ORAL166 mgExact identifier — unii candidate
42 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUSPENSION / AURICULAR (OTIC)NAExact identifier — unii candidate
79 equally ranked IID candidates
Sodium Lauryl SulfateSODIUM LAURYL SULFATE368GB5141JLOTION / TOPICAL111 mgExact identifier — unii candidate
42 equally ranked IID candidates
SorbitolSORBITOL506T60A25RSOLUTION/ DROPS / OPHTHALMIC0.25 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311FILM / BUCCAL18 mgExact identifier — unii candidate
44 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / NASAL250 mgExact identifier — unii candidate
79 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYINJECTION / INTRAMUSCULAR22 mgExact identifier — unii candidate
34 equally ranked IID candidates
Sodium Lauryl SulfateSODIUM LAURYL SULFATE368GB5141JTABLET, CHEWABLE, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
42 equally ranked IID candidates
Sodium Lauryl SulfateSODIUM LAURYL SULFATE368GB5141JSUSPENSION / ORAL705 mgExact identifier — unii candidate
42 equally ranked IID candidates
Sodium Lauryl SulfateSODIUM LAURYL SULFATE368GB5141JCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
42 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311INJECTION, SUSPENSION / INTRAMUSCULAR30 mgExact identifier — unii candidate
44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311TABLET, CHEWABLE / ORAL24.75 mgExact identifier — unii candidate
44 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / INTRAMUSCULAR95 mgExact identifier — unii candidate
79 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKGUM, CHEWING / BUCCAL3492 mgExact identifier — unii candidate
15 equally ranked IID candidates
Sodium Lauryl SulfateSODIUM LAURYL SULFATE368GB5141JTABLET / ORAL233 mgExact identifier — unii candidate
42 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TTABLET, CHEWABLE / ORAL1.28 mgExact identifier — unii candidate
79 equally ranked IID candidates
Sodium Lauryl SulfateSODIUM LAURYL SULFATE368GB5141JDROPS / ORALNAExact identifier — unii candidate
42 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / INTRAVENOUS95 mgExact identifier — unii candidate
79 equally ranked IID candidates
SorbitolSORBITOL506T60A25RINJECTION / SUBCUTANEOUS4.7 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SUSPENSION / ENTERAL2920 mgExact identifier — unii candidate
44 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSUSPENSION / RECTAL290 mgExact identifier — unii candidate
34 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311CAPSULE, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
44 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET / ORAL43 mgExact identifier — unii candidate
34 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET, FILM COATED / ORAL2 mgExact identifier — unii candidate
34 equally ranked IID candidates
SorbitolSORBITOL506T60A25REMULSION / TOPICAL7 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TOINTMENT / OPHTHALMIC0.05 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
SorbitolSORBITOL506T60A25RINJECTION, SOLUTION / INTRAVENOUS4050 mgExact identifier — unii candidate
44 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / RESPIRATORY (INHALATION)0.03 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
Sodium Lauryl SulfateSODIUM LAURYL SULFATE368GB5141JPELLET / ORAL2 mgExact identifier — unii candidate
42 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYELIXIR / ORAL15 mg/5mlExact identifier — unii candidate
34 equally ranked IID candidates
SorbitolSORBITOL506T60A25RINJECTION / INTRALESIONAL45 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCAPSULE / ORAL7 mgExact identifier — unii candidate
79 equally ranked IID candidates
SorbitolSORBITOL506T60A25RSOLUTION / ORAL29268 mgExact identifier — unii candidate
44 equally ranked IID candidates
Sodium Lauryl SulfateSODIUM LAURYL SULFATE368GB5141JCAPSULE, COATED PELLETS / ORAL1 mgExact identifier — unii candidate
42 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET, ORALLY DISINTEGRATING / ORAL10 mgExact identifier — unii candidate
34 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311CAPSULE / ORAL160 mgExact identifier — unii candidate
44 equally ranked IID candidates
SILICA DIMETHYL SILYLATESILICA DIMETHYL SILYLATEEU2PSP0G0WTABLET / ORAL8 mgExact identifier — unii candidate
7 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311AEROSOL, FOAM / VAGINAL0.2 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311TABLET / BUCCAL4 mgExact identifier — unii candidate
44 equally ranked IID candidates
SorbitolSORBITOL506T60A25RSPRAY / NASAL49 mgExact identifier — unii candidate
44 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TLIQUID / ORAL162 mgExact identifier — unii candidate
79 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUMCARBOXYMETHYLCELLULOSE SODIUMK679OBS311TABLET, COATED / ORAL3.2 mgExact identifier — unii candidate
44 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TENEMA / RECTAL0.18 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
SorbitolSORBITOL506T60A25RTABLET, CHEWABLE / ORAL3555 mgExact identifier — unii candidate
44 equally ranked IID candidates
SILICA DIMETHYL SILYLATESILICA DIMETHYL SILYLATEEU2PSP0G0WSUSPENSION / ORAL120 mgExact identifier — unii candidate
7 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION, SOLUTION / PARENTERAL30 mgExact identifier — unii candidate
79 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKTABLET, EXTENDED RELEASE / ORAL229.7 mgExact identifier — unii candidate
15 equally ranked IID candidates

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
0bd50eca-83a5-4c15-95e7-460e07cd8779c7acded8-16ea-4e4f-802e-7a75d3086d312013-07-10WarningsExact identifier
spl id: 0bd50eca-83a5-4c15-95e7-460e07cd8779
spl set id: c7acded8-16ea-4e4f-802e-7a75d3086d31

Reported adverse events (FAERS/openFDA)#

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