FDA.reportPublic FDA data

Charm Tex FLUORIDE Gel

Product NDC
71035-002
11-digit product format
710350002
Labeler code
71035
Product ID
71035-002_3bd5bb42-2961-722f-e063-6394a90ae635
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM FLUORIDE
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 FLUORIDE
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 Gel
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
245598Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
897b0102-1c96-4699-908e-a7b7e26cd29fAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71035-002-01Charm Tex FLUORIDE Gel1000 in 1 PACKAGEPASTE, DENTIFRICE10002
71035-002-01Charm Tex FLUORIDE Gel7.1 g in 1 TUBEPASTE, DENTIFRICE7.12
71035-002-02Charm Tex FLUORIDE Gel17 g in 1 TUBEPASTE, DENTIFRICE172
71035-002-02Charm Tex FLUORIDE Gel720 in 1 PACKAGEPASTE, DENTIFRICE7202
71035-002-03Charm Tex FLUORIDE Gel24 g in 1 TUBEPASTE, DENTIFRICE242
71035-002-03Charm Tex FLUORIDE Gel720 in 1 PACKAGEPASTE, DENTIFRICE7202
71035-002-04Charm Tex FLUORIDE Gel43 g in 1 TUBEPASTE, DENTIFRICE432
71035-002-04Charm Tex FLUORIDE Gel144 in 1 PACKAGEPASTE, DENTIFRICE1442
71035-002-05Charm Tex FLUORIDE Gel78 g in 1 TUBEPASTE, DENTIFRICE782
71035-002-05Charm Tex FLUORIDE Gel144 in 1 PACKAGEPASTE, DENTIFRICE1442
71035-002-06Charm Tex FLUORIDE Gel130 g in 1 TUBEPASTE, DENTIFRICE1302
71035-002-06Charm Tex FLUORIDE Gel60 in 1 PACKAGEPASTE, DENTIFRICE602
71035-002-07Charm Tex FLUORIDE Gel181 g in 1 TUBEPASTE, DENTIFRICE1812
71035-002-07Charm Tex FLUORIDE Gel60 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 4 of 41 · 818 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GingiCaine Gel, Pina ColadaGINGICAINE GEL, PINA COLADA FLAVORGingi-Pak a Division of the Belport6284e1fe-be33-69bf-e053-2991aa0a90ab2026-06-29WarningsExact identifier
application number: M022
GingiCaine Gel, Chocolate MintGINGICAINE GEL, CHOCOLATE MINT FLAVORGingi-Pak a Division of the Belport6285c4f2-c139-49a9-e053-2991aa0a2b032026-06-29WarningsExact identifier
application number: M022
UltraCare Anesthetic GelBENZOCAINEThe Bellport Company, Inc. dba Gingi-Pakf5dd8fa8-0b6a-5a30-e053-2995a90ad1942026-06-26WarningsExact identifier
application number: M022
GingiCaine GelGINGICAINE GEL BANANA FLAVORGingi-Pak a Division of the Belport62857d06-a829-4efa-e053-2991aa0a6d152026-06-25WarningsExact identifier
application number: M022
GingiCaine Gel, Cotton Candy FlavorGINGICAINE GEL, COTTON CANDY FLAVORGingi-Pak a Division of the Belport628515a5-175f-ac2c-e053-2991aa0a19ce2026-06-25WarningsExact identifier
application number: M022
Perox-A-Mint SolutionHYDROGEN PEROXIDESage Products, LLC50823ff5-ad08-4449-bc4a-9a8ae25ec0d52026-06-24WarningsExact identifier
application number: M022
Antiseptic Oral RinseCETYLPYRIDINIUM CHLORIDESage Products LLCefff8bae-154d-46bc-8dd4-7168004256632026-06-24Exact identifier
application number: M022
Anbesol Maximum StrengthBENZOCAINEFoundation Consumer Brands8c6ac499-9bd2-4ea5-9f26-df7947bff4a62026-06-22WarningsExact identifier
application number: M022
Anbesol Maximum StrengthBENZOCAINEFoundation Consumer Brandsdcc37403-0192-4658-bb7a-059273ce00472026-06-22WarningsExact identifier
application number: M022
ToothachePOLYHEXAMETHYLENE BIGUANIDE HYDROCHLORIDEGuchutang Biotechnology (Longyan) Co., Ltd54ad2ceb-272f-e5ba-e063-6394a90aec5f2026-06-20WarningsExact identifier
application number: M022
Hydrogen PeroxideHYDROGEN PEROXIDEDelon Laboratories (1990) Ltdd4aa09bf-8207-47dd-bc42-01e660da94382026-06-16WarningsExact identifier
application number: M022
TideFresh MOUTH SORE AND TOOTHACHEBENZOCAINE 20% MOUTH SORE AND TOOTHACHEWenzhou Yuyuan Pharmaceutical Co., Ltd.541e1814-c00e-efdf-e063-6394a90a41a12026-06-13WarningsExact identifier
application number: M022
Chloraseptic Sore Throat MaxPHENOL AND GLYCERINPrestige Brands Holdings, Inc.882c940c-b3c3-4aa4-8d64-e4260f066ff42026-06-08WarningsExact identifier
application number: M022
OrazenSODIUM MONOFLUOROPHOSPHATEOrazen Incfa5b6bd8-443f-79e7-e053-6394a90a55132026-06-03WarningsExact identifier
application number: M022
Fishermans Friend Mixed BerryMENTHOLLofthouse of Fleetwood53391c4d-ee2d-ade3-e063-6394a90ac77d2026-06-01WarningsExact identifier
application number: M022
Orajel Medicated for Toothache and Gum, LiquidBENZOCAINE AND MENTHOLChurch & Dwight Co., Inc.ac3d605d-241d-1a6f-e053-2a95a90ae3912026-06-01WarningsExact identifier
application number: M022
MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEFBENZOCAINE AND MENTHOL, UNSPECIFIED FORMReckitt Benckiser LLC6140d487-d87c-4954-9247-83492bcc57382026-05-27WarningsExact identifier
application number: M022
Dolodent Maximum StrengthBENZOCAINEPharmadel LLC351ecc2b-cc1a-2bbf-e063-6394a90a5c142026-05-26WarningsExact identifier
application number: M022
MOUTH ULCERPANTHENOLGuangzhou Shengli Shidai Cosmetics Co., Ltd.5264f81c-bffe-4f6d-e063-6394a90ae3bf2026-05-22WarningsExact identifier
application number: M022
Sensitivity Relief Fluoride FreePOTASSIUM NITRATEHealth and Natural Beauty USA Corpc23b2a83-ebc3-4bcf-a216-7693944dcfa02026-05-22WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
245598sodium fluoride 0.22 % ToothpastePSN897b0102-1c96-4699-908e-a7b7e26cd29f2
245598sodium fluoride 0.0022 MG/MG ToothpasteSCD897b0102-1c96-4699-908e-a7b7e26cd29f2
245598sodium fluoride 0.22 % (fluoride 0.1 % ) ToothpasteSY897b0102-1c96-4699-908e-a7b7e26cd29f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71035-002-01710350002011000 TUBE in 1 PACKAGE (71035-002-01) / 7.1 g in 1 TUBE1000 tube2025-06-13NoNoCurrent
71035-002-0271035000202720 TUBE in 1 PACKAGE (71035-002-02) / 17 g in 1 TUBE720 tube2025-06-13NoNoCurrent
71035-002-0371035000203720 TUBE in 1 PACKAGE (71035-002-03) / 24 g in 1 TUBE720 tube2025-06-13NoNoCurrent
71035-002-0471035000204144 TUBE in 1 PACKAGE (71035-002-04) / 43 g in 1 TUBE144 tube2025-06-13NoNoCurrent
71035-002-0571035000205144 TUBE in 1 PACKAGE (71035-002-05) / 78 g in 1 TUBE144 tube2025-06-13NoNoCurrent
71035-002-067103500020660 TUBE in 1 PACKAGE (71035-002-06) / 130 g in 1 TUBE60 tube2025-06-13NoNoCurrent
71035-002-077103500020760 TUBE in 1 PACKAGE (71035-002-07) / 181 g in 1 TUBE60 tube2025-06-13NoNoCurrent