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 8 of 41 · 818 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SIGNATURE CARE SORE THROAT CHERRY FLAVORPHENOLSAFEWAY94a2c1b9-f462-4489-b84a-825a82835d302026-02-23WarningsExact identifier
application number: M022
Sore Mouth CleanserHYDROGEN PEROXIDEMeijer, Inc.c9c17224-9304-403a-b6a1-9c8bd94e3d942026-02-19Warnings, Adverse reactionsExact identifier
application number: M022
AQUAFRESH CAVITY PROTECTIONSODIUM FLUORIDEHaleon US Holdings LLC5484999c-8e6f-430d-99a5-6893a24894672026-02-16WarningsExact identifier
application number: M022
AQUAFRESH EXTREME CLEAN WHITENING ACTIONSODIUM FLUORIDEHaleon US Holdings LLCaaff19d9-4ba5-462a-893b-7220feb25d6c2026-02-16WarningsExact identifier
application number: M022
Oral Sore AntisepticHYDROGEN PEROXIDE, MENTHOLWalgreen Co.55807b18-42ed-45a7-845e-fcf7f5d70d042026-02-12Warnings, Adverse reactionsExact identifier
application number: m022
Sore Mouth CleanserHYDROGEN PEROXIDEWalgreen Co.33223589-4ff4-4e4e-96da-6fa2e4d0f1872026-02-12Warnings, Adverse reactionsExact identifier
application number: M022
PERIOSCIENCES SENSITIVE AO ProPOTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATEPERIOSCIENCES LLCacca8964-b575-468c-8b40-514dfbf507782026-02-09WarningsExact identifier
application number: M022
Oral Sore AntisepticHYDROGEN PEROXIDE, MENTHOLRetail Business Services, LLCd46546d0-c6df-431a-8ab0-bc5013c084d72026-02-06Warnings, Adverse reactionsExact identifier
application number: M022
Hydrogen Peroxide 3 PercentHYDROGEN PEROXIDEEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)e19228e9-6f87-456e-a222-f979a234d5892026-02-06WarningsExact identifier
application number: M022
Listerine UltraClean Plus Whitening Protection Intense Antiseptic Antigingivitis/ Antiplaque MouthwashEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLC49d28991-b68f-ba16-e063-6394a90a0b132026-02-02WarningsExact identifier
application number: M022
Sootheez Strawberry LemonadePECTINPrimrose Candy Co.49e2b303-1018-cd13-e063-6394a90ae3002026-02-02WarningsExact identifier
application number: M022
Sootheez Berry LemonadePECTINPrimrose Candy Co.49cee56f-c45f-6c79-e063-6294a90a5f8f2026-02-01WarningsExact identifier
application number: M022
Sore Mouth CleanserHYDROGEN PEROXIDERite Aid Corporation294418aa-640d-42be-ad07-de31da7a7ccc2026-01-30Warnings, Adverse reactionsExact identifier
application number: M022
Ora YoGu 4X Medicated Tooth and Gum Pain RelieverMEDICATED TOOTH AND GUM PAIN RELIEVERKungpo Health Care & Herbal Center Incaa61ce6f-8336-4071-93b8-549fd22d1ae02026-01-22WarningsExact identifier
application number: M022
Colgate Sensitive Complete ProtectionPOTASSIUM NITRATE AND SODIUM FLUORIDEColgate-Palmolive Company866067b9-3dce-492d-ae99-1b807ecd56ff2026-01-22WarningsExact identifier
application number: M022
Family Wellness Pain ReliefBENZOCAINE 20%FAMILY DOLLAR (Family Wellness)92fa0693-fca5-4bf9-8fce-a2d7e9ca37ea2026-01-21WarningsExact identifier
application number: M022
Crest Pro-Health All Day Clean BreathCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company48eaca4c-19c2-2dd2-e063-6394a90a3e082026-01-21WarningsExact identifier
application number: M022
Betadine GarglePOVIDONE-IODINEAtlantis Consumer Healthcare, Inc.5f0a3377-1398-2603-c632-f0d214bb88ec2026-01-21WarningsExact identifier
application number: M022
ORAL PAIN RELIEFBENZOCAINEUniversal Distribution Center LLCe276ba37-46fb-4ed9-9ee1-c08a2a89704a2026-01-20WarningsExact identifier
application number: M022
Equate Orasol20% BENZOCAINEWAL-MART STORES INC.08404780-8252-4484-b1c3-8970803f74f82026-01-19WarningsExact 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