FDA.reportPublic FDA data

Charm Tex FLUORIDE

Product NDC
71035-001
11-digit product format
710350001
Labeler code
71035
Product ID
71035-001_3ca5d2b2-d884-a6b1-e063-6394a90a970d
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM MONOFLUOROPHOSPHATE
Dosage form
PASTE, DENTIFRICE
Route
TOPICAL
Labeler
Yangzhou Hongshengding Chemical Co.,Ltd.
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-13
Substance
SODIUM MONOFLUOROPHOSPHATE
Active strength
.1 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Charm Tex FLUORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM MONOFLUOROPHOSPHATE.1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
C810JCZ56QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
545626Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
63a69664-8611-4d69-b871-8d1d5b553e5cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71035-001-01Charm Tex FLUORIDE720 in 1 PACKAGEPASTE, DENTIFRICE7202
71035-001-01Charm Tex FLUORIDE17 g in 1 TUBEPASTE, DENTIFRICE172
71035-001-02Charm Tex FLUORIDE24 g in 1 TUBEPASTE, DENTIFRICE242
71035-001-02Charm Tex FLUORIDE720 in 1 PACKAGEPASTE, DENTIFRICE7202
71035-001-03Charm Tex FLUORIDE43 g in 1 TUBEPASTE, DENTIFRICE432
71035-001-03Charm Tex FLUORIDE144 in 1 PACKAGEPASTE, DENTIFRICE1442
71035-001-04Charm Tex FLUORIDE78 g in 1 TUBEPASTE, DENTIFRICE782
71035-001-04Charm Tex FLUORIDE144 in 1 PACKAGEPASTE, DENTIFRICE1442
71035-001-05Charm Tex FLUORIDE130 g in 1 TUBEPASTE, DENTIFRICE1302
71035-001-05Charm Tex FLUORIDE60 in 1 PACKAGEPASTE, DENTIFRICE602
71035-001-06Charm Tex FLUORIDE181 g in 1 TUBEPASTE, DENTIFRICE1812
71035-001-06Charm Tex FLUORIDE60 in 1 PACKAGEPASTE, DENTIFRICE602

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 7 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lemon GlycerinGLYCERINDynarex Corporation99fc00ea-9d55-0380-e053-2995a90a2c0b2026-03-24WarningsExact identifier
application number: M022
Dual-FormulaToothpaste for sensitive teethDUAL-FORMULA TOOTHPASTE FOR SENSITIVE TEETHHangzhou Namei Zhikang Technology Co., Ltd.4d735f91-8abc-3a30-e063-6394a90a76392026-03-20WarningsExact identifier
application number: M022
SmileCare Mouth Ulcer GelMENTHOLYantai Aien Biotechnology Co., Ltd.4d6db039-5b97-8f3f-e063-6294a90a9d852026-03-19WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINENational Distribution & Contracting, Inc9f91e609-8ca5-0492-e053-2a95a90a85d02026-03-17WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINENational Distribution & Contracting, Inc9f81ffa5-05fd-4eef-e053-2995a90aac3e2026-03-17WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINENational Distribution & Contracting, Inc9f947366-9380-3fa9-e053-2a95a90ad49c2026-03-17WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINENational Distribution & Contracting, Inc9f947672-4873-5546-e053-2a95a90a3c4b2026-03-17WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINENational Distribution & Contracting, Inc9f9490c1-8bfe-3166-e053-2a95a90a71752026-03-17WarningsExact identifier
application number: M022
Quala Topical Anesthetic GelBENZOCAINENational Distribution & Contracting, Inc9f94b65d-47e3-9c6b-e053-2a95a90aa1f82026-03-17WarningsExact identifier
application number: M022
BencoCaine Topical AnestheticBENZOCAINEBenco Dental4d3e03ee-6e0f-c9ae-e063-6394a90a6f5b2026-03-17WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC043c00a6-1346-7780-e063-6294a90a3d5a2026-03-12WarningsExact identifier
application number: M022
ORAL PAIN RELIEFBENZOCAINENantong Health & Beyond Hygienic Products Inc.a5f0be98-d47e-4307-8044-304a64db774b2026-03-11WarningsExact identifier
application number: M022
SENSODYNE PRONAMEL Intensive Enamel Repair WhiteningPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLCa2f9d58b-671b-4427-a971-1fceff5f23232026-03-09WarningsExact identifier
application number: M022
Sore Mouth CleanserHYDROGEN PEROXIDECVS Pharmacy, Inc.a5dbaadf-76a8-4c48-af2d-f4455e9411f02026-03-09Warnings, Adverse reactionsExact identifier
application number: M022
Hydrogen Peroxide 3 PercentHYDROGEN PEROXIDESam's West, Inc78a3e024-73da-40b7-9d9c-099fd6ca9b9e2026-03-03WarningsExact identifier
application number: M022
Sore ThroatPHENOL GLYCERINCVS PHARMACY, INC9683bcfb-2f7e-48a4-aa79-500ee8df099a2026-03-02WarningsExact identifier
application number: M022
Spring Gene Oil Pulling SensitivityPOTASSIUM NITRATEHealth and Natural Beauty USA Corp294051e3-69ec-4190-8b03-fa34988376b72026-02-26WarningsExact identifier
application number: M022
Lolleez WatermelonPECTINBFY LLC4ba8af8b-5a17-8b8c-e063-6394a90a63f32026-02-25WarningsExact identifier
application number: M022
Oral Sore AntisepticHYDROGEN PEROXIDE, MENTHOLH E Bf1450866-1be4-46d9-9fe4-52d699636b4f2026-02-24Warnings, Adverse reactionsExact identifier
application number: M022
SIGNATURE CARE SORE THROAT CHERRY FLAVORPHENOLSAFEWAY94a2c1b9-f462-4489-b84a-825a82835d302026-02-23WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN63a69664-8611-4d69-b871-8d1d5b553e5c2
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD63a69664-8611-4d69-b871-8d1d5b553e5c2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY63a69664-8611-4d69-b871-8d1d5b553e5c2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY63a69664-8611-4d69-b871-8d1d5b553e5c2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY63a69664-8611-4d69-b871-8d1d5b553e5c2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY63a69664-8611-4d69-b871-8d1d5b553e5c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71035-001-0171035000101720 TUBE in 1 PACKAGE (71035-001-01) / 17 g in 1 TUBE720 tube2025-06-13NoNoCurrent
71035-001-0271035000102720 TUBE in 1 PACKAGE (71035-001-02) / 24 g in 1 TUBE720 tube2025-06-13NoNoCurrent
71035-001-0371035000103144 TUBE in 1 PACKAGE (71035-001-03) / 43 g in 1 TUBE144 tube2025-06-13NoNoCurrent
71035-001-0471035000104144 TUBE in 1 PACKAGE (71035-001-04) / 78 g in 1 TUBE144 tube2025-06-13NoNoCurrent
71035-001-057103500010560 TUBE in 1 PACKAGE (71035-001-05) / 130 g in 1 TUBE60 tube2025-06-13NoNoCurrent
71035-001-067103500010660 TUBE in 1 PACKAGE (71035-001-06) / 181 g in 1 TUBE60 tube2025-06-13NoNoCurrent