Home NDC 71035-002 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 Ingredient Strength SODIUM FLUORIDE .1 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8ZYQ1474W7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 245598 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 71035-002-01 Charm Tex FLUORIDE Gel 1000 in 1 PACKAGE PASTE, DENTIFRICE 1000 2 71035-002-01 Charm Tex FLUORIDE Gel 7.1 g in 1 TUBE PASTE, DENTIFRICE 7.1 2 71035-002-02 Charm Tex FLUORIDE Gel 17 g in 1 TUBE PASTE, DENTIFRICE 17 2 71035-002-02 Charm Tex FLUORIDE Gel 720 in 1 PACKAGE PASTE, DENTIFRICE 720 2 71035-002-03 Charm Tex FLUORIDE Gel 24 g in 1 TUBE PASTE, DENTIFRICE 24 2 71035-002-03 Charm Tex FLUORIDE Gel 720 in 1 PACKAGE PASTE, DENTIFRICE 720 2 71035-002-04 Charm Tex FLUORIDE Gel 43 g in 1 TUBE PASTE, DENTIFRICE 43 2 71035-002-04 Charm Tex FLUORIDE Gel 144 in 1 PACKAGE PASTE, DENTIFRICE 144 2 71035-002-05 Charm Tex FLUORIDE Gel 78 g in 1 TUBE PASTE, DENTIFRICE 78 2 71035-002-05 Charm Tex FLUORIDE Gel 144 in 1 PACKAGE PASTE, DENTIFRICE 144 2 71035-002-06 Charm Tex FLUORIDE Gel 130 g in 1 TUBE PASTE, DENTIFRICE 130 2 71035-002-06 Charm Tex FLUORIDE Gel 60 in 1 PACKAGE PASTE, DENTIFRICE 60 2 71035-002-07 Charm Tex FLUORIDE Gel 181 g in 1 TUBE PASTE, DENTIFRICE 181 2 71035-002-07 Charm Tex FLUORIDE Gel 60 in 1 PACKAGE PASTE, DENTIFRICE 60 2
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 16 of 40 · 786 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join GuruNanda Oxyfusion HYDROGEN PEROXIDE GURUNANDA, LLC 3be317b9-a5d8-b198-e063-6394a90af985 2025-11-11 Warnings Exact identifier application number: M022 GuruNanda Oral Pain Relief MENTHOL GURUNANDA, LLC 3b8f3562-0e46-bea4-e063-6294a90adb71 2025-11-11 Warnings Exact identifier application number: M022 TopCare Cherry Flavor PHENOL TOPCO ASSOCIATES, LLC 5d3f0610-deb4-4180-ae19-2c65ed2f368b 2025-11-10 Warnings Exact identifier application number: M022 Topcare Sore Throat Menthol Flavor PHENOL TOPCO ASSOCIATES LLC fb1f2c11-2508-4985-bae5-7d547bd6aa23 2025-11-10 Warnings Exact identifier application number: M022 Zilactin-B BENZOCAINE ASCENT CONSUMER PRODUCTS, INC 42eeb3d4-bac6-4e29-e063-6294a90a644d 2025-11-06 Warnings Exact identifier application number: M022 Zilactin Early Relief Cold Sore BENZYL ALCOHOL ASCENT CONSUMER PRODUCTS, INC 42ef8bfa-c4d9-01cf-e063-6394a90ac88a 2025-11-06 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic Gel BENZOCAINE Beutlich Pharmaceuticals, LLC 106b6115-d043-4050-80c6-1d82456dea02 2025-11-06 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic Gel BENZOCAINE Beutlich Pharmaceuticals, LLC 4c278122-2643-46bf-9e44-11985210a16e 2025-11-06 Warnings Exact identifier application number: M022 HurriCaine Topical Anesthetic Liquid BENZOCAINE Beutlich Pharmaceuticals, LLC fee9969d-ad1a-4f44-9741-a0a44c9e1128 2025-11-06 Warnings Exact identifier application number: M022 Ear Wax Removal Aid Drops CARBAMIDE PEROXIDE Target Corporation 0ddf9945-147d-4b25-98a6-4e9f12a4656f 2025-11-05 Warnings Exact identifier application number: M022 Alpha-Caine Topical Anesthetic BENZOCAINE Dental Technologies, Inc. e6a312e5-17ac-46f0-8723-4e40eeecd69f 2025-11-04 Warnings Exact identifier application number: M022 PEROXY SHIELD MOUTH SORE 1.5% HYDROGEN PEROXIDE Dental Technologies, Inc. a72e433b-1b7d-4a0c-e053-2995a90a30c4 2025-11-04 Warnings Exact identifier application number: M022 Alpha-Caine Topical Anesthetic BENZOCAINE Dental Technologies, Inc. ae628766-25b7-4b4f-abb8-a43faf2f44b9 2025-11-04 Warnings Exact identifier application number: M022 Alpha-Caine Topical Anesthetic BENZOCAINE Dental Technologies, Inc. 719743f9-21fc-4568-b879-acdfa4639464 2025-11-04 Warnings Exact identifier application number: M022 Alpha-Caine Topical Anesthetic BENZOCAINE Dental Technologies, Inc. ff0695a1-1d7d-4b51-97fd-689e56d914fe 2025-11-04 Warnings Exact identifier application number: M022 Antiseptic EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL Family Dollar (FAMILY WELLNESS) f7edf75c-cdba-4dde-bfc5-a04af34759d3 2025-11-03 Warnings Exact identifier application number: M022 7 Select Oral Pain Maximum Strength Relief BENZOCAINE 7-ELEVEN, INC. f170a570-1c50-4b9a-be16-9b01bf5eaa74 2025-10-31 Warnings Exact identifier application number: M022 Oral Pain Relief BENZOCAINE AND BENZALKONIUM CHLORIDE Universal Distribution Center LLC 18520f9b-4d35-1e9c-e063-6294a90aaa39 2025-10-30 Warnings Exact identifier application number: M022 Iodent Oral Analgesic BENZOCAINE United Exchange Corp. 63902125-f8dc-0ada-e053-2991aa0a7ce5 2025-10-30 Warnings Exact identifier application number: M022 Ear Wax Removal Aid Drops CARBAMIDE PEROXIDE BETTER LIVING BRANDS, LLC 3bded237-4d2c-4b38-bedc-267fdc374194 2025-10-29 Warnings Exact identifier application number: M022
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 71035-002-01 71035000201 1000 TUBE in 1 PACKAGE (71035-002-01) / 7.1 g in 1 TUBE 1000 tube 2025-06-13 No No Current 71035-002-02 71035000202 720 TUBE in 1 PACKAGE (71035-002-02) / 17 g in 1 TUBE 720 tube 2025-06-13 No No Current 71035-002-03 71035000203 720 TUBE in 1 PACKAGE (71035-002-03) / 24 g in 1 TUBE 720 tube 2025-06-13 No No Current 71035-002-04 71035000204 144 TUBE in 1 PACKAGE (71035-002-04) / 43 g in 1 TUBE 144 tube 2025-06-13 No No Current 71035-002-05 71035000205 144 TUBE in 1 PACKAGE (71035-002-05) / 78 g in 1 TUBE 144 tube 2025-06-13 No No Current 71035-002-06 71035000206 60 TUBE in 1 PACKAGE (71035-002-06) / 130 g in 1 TUBE 60 tube 2025-06-13 No No Current 71035-002-07 71035000207 60 TUBE in 1 PACKAGE (71035-002-07) / 181 g in 1 TUBE 60 tube 2025-06-13 No No Current