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 25 of 40 · 786 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Candee Caine Topical Anesthetic BENZOCAINE American Medical & Hospital Supply Co., Inc. 0192ccf9-1715-4e23-a6bf-8bd838cd8b0d 2025-01-09 Warnings Exact identifier application number: M022 Candee Caine Topical Anesthetic BENZOCAINE American Medical & Hospital Supply Co., Inc. edcb8451-6fa7-4bc2-95f6-2a0806f7f3da 2025-01-09 Warnings Exact identifier application number: M022 Candee Caine Topical Anesthetic BENZOCAINE American Medical & Hospital Supply Co., Inc. 576660ed-203a-4842-9d39-c5be10daf976 2025-01-09 Warnings Exact identifier application number: M022 Candee Caine Topical Anesthetic BENZOCAINE American Medical & Hospital Supply Co., Inc. 1796b3ec-833a-4cf1-ba50-bc4da827f84f 2025-01-09 Warnings Exact identifier application number: M022 Candee Caine Topical Anesthetic BENZOCAINE American Medical & Hospital Supply Co., Inc. d923fa75-f556-45e3-9f52-39a62e89984b 2025-01-09 Warnings Exact identifier application number: M022 Candee Caine Topical Anesthetic BENZOCAINE American Medical & Hospital Supply Co., Inc. cd3ede8c-2c77-4d81-8dff-8198025a2156 2025-01-09 Warnings Exact identifier application number: M022 KAYLAAN ZERO WASTE REFILL FOR TOOTHPASTE Kaylaan LLC cb7f5f9b-4192-15e6-e053-2995a90a6457 2025-01-09 Warnings Exact identifier application number: M022 KAYLAAN ZERO WASTE REFILL FOR TOOTHPASTE Kaylaan LLC 2b494372-de59-e462-e063-6294a90a08da 2025-01-09 Warnings Exact identifier application number: M022 Dental City Topical Anesthetic BENZOCAINE ICP Inc DBA Dental City a225d515-430d-4e34-846c-0bfec3e74109 2025-01-09 Warnings Exact identifier application number: M022 Dental City Topical Anesthetic BENZOCAINE ICP Inc DBA Dental City 372f99c9-4ad3-4631-b8c8-2a34c47343cc 2025-01-09 Warnings Exact identifier application number: M022 Dental City Topical Anesthetic BENZOCAINE ICP Inc DBA Dental City e554b5b2-cf91-464a-a930-3e1087f12c8d 2025-01-09 Warnings Exact identifier application number: M022 Dental City Topical Anesthetic BENZOCAINE ICP Inc DBA Dental City 98da331c-76c2-49fe-b687-6bfba4ae2e75 2025-01-09 Warnings Exact identifier application number: M022 Dental City Topical Anesthetic BENZOCAINE ICP Inc DBA Dental City d2195efa-597d-4ba9-a9b0-8df0d8f49311 2025-01-09 Warnings Exact identifier application number: M022 Dental City Topical Anesthetic BENZOCAINE ICP Inc DBA Dental City fba82d55-94db-4432-b532-603fe57202be 2025-01-09 Warnings Exact identifier application number: M022 Dental City Topical Anesthetic BENZOCAINE ICP Inc DBA Dental City 9ed0fe31-e5f2-4d6d-8686-1286c6659847 2025-01-09 Warnings Exact identifier application number: M022 Dental City Topical Anesthetic BENZOCAINE ICP Inc DBA Dental City d5f42c30-343c-4e1d-950c-89bbd361fd27 2025-01-09 Warnings Exact identifier application number: M022 Dental City Topical Anesthetic BENZOCAINE ICP Inc DBA Dental City 7dce407f-bbe4-4a27-97ff-be33fd447461 2025-01-09 Warnings Exact identifier application number: M022 KAYLAAN ZERO WASTE REFILL FOR TOOTHPASTE Kaylaan LLC cb7f28f3-a908-47a9-e053-2995a90a6cbd 2025-01-09 Warnings Exact identifier application number: M022 GPS Topical Anesthetic BENZOCAINE Group Practice Solutions, Inc. 921bdb76-f6d3-4e0a-a0ac-277dcc4e8d28 2025-01-09 Warnings Exact identifier application number: M022 GPS Topical Anesthetic BENZOCAINE Group Practice Solutions, Inc. a80cfd29-8314-4639-a811-afd5fdb630b0 2025-01-09 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