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 13 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
S.T.37HEXYLRESORCINOLNUMARK BRANDS, INC7d7acca2-aa8a-5272-e813-faab039cc7982025-12-15WarningsExact identifier
application number: M022
Esunix Oral Bacteriostatic GelCETYLPYRIDINIUM CHLORIDEXiling (Zhenjiang) Medical Technology Co., Ltd.3f4ee467-8142-8cb7-e063-6394a90aa7f72025-12-12WarningsExact identifier
application number: M022
Orajel 4X Medicated For Toothache and GumBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.999851ac-925c-7d1f-e053-2a95a90a240b2025-12-12WarningsExact identifier
application number: M022
Orajel 3X Medicated For Toothache and GumBENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.99a2b061-0875-59a4-e053-2995a90ab3732025-12-12WarningsExact identifier
application number: M022
Orajel Antiseptic Rinse For All Mouth SoresHYDROGEN PEROXIDE AND MENTHOLChurch & Dwight Co., Inc.06188d36-0d60-6ae6-e054-00144ff8d46c2025-12-12WarningsExact identifier
application number: M022
Orajel 3X Medicated For All Mouth SoresBENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.99b589ac-9833-fb60-e053-2995a90a09352025-12-12WarningsExact identifier
application number: M022
Orajel 4X Medicated For Toothache and Gum, CreamBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.999aa7b9-bf9e-9285-e053-2a95a90a345b2025-12-12WarningsExact identifier
application number: M022
Orajel 4X Medicated PM For Toothache and GumBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.999cff2b-c23e-5abe-e053-2a95a90a75692025-12-12WarningsExact identifier
application number: M022
Benzoin Compound TinctureBENZOIN RESINHumco Holding Group, Inc.a893a232-2ea8-4e0d-8cbf-7f5040b3be2e2025-12-11WarningsExact identifier
application number: M022
Listerine Original Intense Antiseptic Antigingivitis/ Antiplaque MouthwashEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLC456d45e8-bf6d-31c4-e063-6394a90a5c002025-12-10WarningsExact identifier
application number: M022
Oral pain reliefBENZOCAINEALAINA HEALTHCARE PRIVATE LIMITEDd98c1b2f-fe75-4d52-b082-1abb7628c59e2025-12-09WarningsExact identifier
application number: M022
HEB Sensitive Extra Whitening TwinSODIUM FLUORIDEHEB41d5ae3e-51c1-263b-e063-6394a90a33122025-12-08WarningsExact identifier
application number: M022
CankerMeltsBENZOCAINEQuest Products, LLC070dae82-14c2-66d2-e063-6394a90ab2592025-12-04WarningsExact identifier
application number: M022
Sore Throat ReadyInCasePHENOLP & L Development, LLC2fb3d17e-8ca3-4edb-8b82-4b484f42616e2025-12-03WarningsExact identifier
application number: M022
Listerine Cool Mint Intense Antiseptic Antigingivitis/ Antiplaque MouthwashEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLC44f2b66a-26ae-1044-e063-6394a90a9ab62025-12-02WarningsExact identifier
application number: M022
Sensodyne Fresh CleanSTANNOUS FLUORIDEHaleon US Holdings LLC2d433ac1-3ddf-a2f4-e063-6394a90a91f82025-12-01WarningsExact identifier
application number: M022
Walgreens SalineNASALWALGREEN COMPANY147e45c8-1e71-4c06-89f1-42e9f96833662025-12-01WarningsExact identifier
application number: M022
EELHOE Probiotic Bright White FreshGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.425cec0e-aa74-5341-e063-6294a90ac86b2025-11-27WarningsExact identifier
application number: M022
EELHOE 5 Days Tooth PowderGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.42f98b14-d1d5-4af8-e063-6294a90a8f672025-11-27WarningsExact identifier
application number: M022
JAYSUING Colour CorrectorGLYCERINShantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.425d9c23-a692-3c62-e063-6294a90a94042025-11-27WarningsExact 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