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 21 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fluoride Anti Caries 65g Coconut Whip Juicy Peach Mango Smoothie Summer Watermelon Hami Melom Cream Strawberries BlueberryFLUORIDE ANTI CARIES TOOTHPASTE 65G COCONUT WHIP JUICY PEACH MANGO SMOOTHIE SUMMER WATERMELON HAMI MELOM CREAM STRAWBERRIES BLUEBERRYWORLD DENTISTS ASSOCIATION AMERICA LIMITED3573f149-2af9-4c86-e063-6294a90a7b3f2025-05-18WarningsExact identifier
application number: M022
Bubble Gum Flavor For Kids 25g 50gBUBBLE GUM FLAVOR TOOTHPASTE FOR KIDS 25G 50GWORLD DENTISTS ASSOCIATION AMERICA LIMITED354c1eda-ec5b-a8c7-e063-6294a90a871d2025-05-16WarningsExact identifier
application number: M022
Hydrogen PeroxideHYDROGEN PEROXIDESafeway, Inc.8fe2f1df-3264-455d-b62c-953dce171c022025-05-16WarningsExact identifier
application number: M022
Parodontax Active Gum Health Daily Mouthwash Breath FreshenerCETYLPYRIDINIUM CHLORIDEHaleon US Holdings LLC32b632bf-058d-447b-a7fb-a9dd05c1e2b82025-05-08WarningsExact identifier
application number: M022
Parodontax Active Gum Health Clear MintCETYLPYRIDINIUM CHLORIDEHaleon US Holdings LLC444f931d-5e38-4cda-97ba-98aa0b5fe4f62025-05-08WarningsExact identifier
application number: M022
Listerine Clinical Solutions Gum Health Icy MintEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLC06e1122b-1100-43c0-e063-6394a90a2e782025-04-22WarningsExact identifier
application number: M022
Hydrogen PeroxideHYDROGEN PEROXIDEStrategic Sourcing Services LLC5260258a-bb1e-43d6-bce1-70a38778a64a2025-04-14WarningsExact identifier
application number: M022
Hydrogen Peroxide 3 PercentHYDROGEN PEROXIDETARGET Corporation93d0bb3a-51d3-44c8-8fb7-bdb82adfbb652025-04-14WarningsExact identifier
application number: M022
Listerine Ultraclean Antiseptic Cool MintEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLCee467ec4-bd5e-644a-e053-2a95a90ac2732025-04-10WarningsExact identifier
application number: M022
MouthwashMENTHOL, METHYL SALICYLATE, THYMOLOrazen Inc873c43df-1d46-359b-e053-2a91aa0a43192025-04-07WarningsExact identifier
application number: M022
Sensodyne Complete Protection Extra FreshSTANNOUS FLUORIDEHaleon US Holdings LLCe3cc3146-8aed-4f6b-a252-e379418c2b8d2025-03-26WarningsExact identifier
application number: M022
Listerine Freshburst AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLCee1e1df9-74c6-d24b-e053-2a95a90a43d32025-03-04WarningsExact identifier
application number: M022
Listerine Cool Mint AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLCedb9e374-4dba-5823-e053-2a95a90a3da52025-03-03WarningsExact identifier
application number: M022
Hydrogen Peroxide 3 PercentHYDROGEN PEROXIDEGood Sense (Geiss, Destin & Dunn, Inc.)cfe9be26-e4a4-413c-a602-2f5948e3bb7a2025-03-03WarningsExact identifier
application number: M022
LISTERINE Original AntisepticEUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOLKenvue Brands LLC78e2e172-09a4-4bf1-9871-d099c49087be2025-02-28WarningsExact identifier
application number: M022
WHITE GLO CHARCOAL SENSITIVEPOTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCa5edb7fd-c637-5447-e053-2995a90a5a6f2025-02-26WarningsExact identifier
application number: M022
Glorysmile Toothpaste.GLORYSMILE TOOTHPASTE.Jiangxi Dentalbright Technology Co., Ltd2ef48156-904d-e42a-e063-6394a90a3cd02025-02-25WarningsExact identifier
application number: M022
Hydrogen Peroxide 3 PercentHYDROGEN PEROXIDEWalgreensc4e76d1d-1cee-4eeb-a2e4-6e9b1cac56fa2025-02-21WarningsExact identifier
application number: M022
Sheffield Pain ReliefBENZOCAINESheffield Pharmaceuticals LLCe21abfdd-373d-42af-9535-fe1571382a652025-02-19WarningsExact identifier
application number: M022
Hydrogen Peroxide 3 PercentHYDROGEN PEROXIDEWhole Foods Marketa2bb142e-8cbe-481e-bf4f-810ca6d145912025-02-12WarningsExact 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