FDA.reportPublic FDA data

Charm Tex FLUORIDE Gel

Product NDC
42086-052
11-digit product format
420860052
Labeler code
42086
Product ID
42086-052_53168f8d-5f38-1bfb-e063-6294a90a5e25
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM FLUORIDE
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Jiangsu Gold Worldworks Household Chemicals Co., Ltd.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-05-31
Substance
SODIUM FLUORIDE
Active strength
.1 g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
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
2027-12-31

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
09d47bd7-1438-4ef2-85e0-9cd5eb2f763aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

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 77 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Xpect Extra Strength Itch ReliefDIPHENHYDRAMINE HYDROCHLORIDECintas Corporationa373b2c3-5c58-4b64-9358-bdf42dfce08c2025-09-24WarningsExact identifier
application number: M017
Xpect Burn CareBURN CARECintas Corp3665eb99-9602-4949-8af4-3ce7ed24303c2025-09-23WarningsExact identifier
application number: M017
Sheffield Arthritis and Muscle Pain ReliefCAPSICUM OLEORESINSheffield Pharmaceuticals LLC80a1bc65-2986-491f-a062-307d28b08ccb2025-09-22WarningsExact identifier
application number: M017
TheraCare Roll-on Menthol 16% Pain Relief LiquidMENTHOLVeridian Healthcared932050d-2a9a-4a5e-b45d-0a7a864582e02025-09-22WarningsExact identifier
application number: M017
TheraCare Roll-on Menthol 4% Pain ReliefMENTHOLVeridian Healthcarefa121e5f-94b5-4c1d-9c4e-85bb8ede39452025-09-22WarningsExact identifier
application number: M017
Asper FlexLIDOCAINEAkron Pharma Inc.06ddae64-cda7-4eb9-872f-5182c83cb00c2025-09-19WarningsExact identifier
application number: M017
Good Neighbor Pain Relief Patch With Lidocaine 4%LIDOCAINEAmerisource Bergen5f5cc887-d479-4c9a-affc-49d0c331f7422025-09-18WarningsExact identifier
application number: M017
TheraCare Roll-on Lidocaine Pain Relief LiquidLIDOCAINE HCIVeridian Healthcaree942d447-754d-4683-9c99-57c7e83d7ea82025-09-18WarningsExact identifier
application number: M017
TheraCare Roll-on Lidocaine Pain Relief Liquid - LavenderLIDOCAINE HCIVeridian Healthcare6bebce76-30f6-4070-b0fe-58246d0713282025-09-18WarningsExact identifier
application number: M017
HealthWise Roll-On Lidocaine Pain Relief LiquidLIDOCAINE HCIVeridian Healthcare1133f6d4-f4c0-4ce9-e063-6394a90a5f4e2025-09-18WarningsExact identifier
application number: M017
InkKulture NumbingLIDOCAINE HCLProdigy Media Inc85a64315-dfa5-4f23-9f61-1cce694ea6bd2025-09-17WarningsExact identifier
application number: M017
Ink Scribd NumbingLIDOCAINE HCLProdigy Media Inc54173858-aff0-43b2-bc7b-c4ecab9bc3e52025-09-17WarningsExact identifier
application number: M017
Inkorporated NumbingLIDOCAINE HCLProdigy Media Inc3017056c-f3c6-4300-8344-bf6e7d32e8702025-09-17WarningsExact identifier
application number: M017
TattooGirl NumbingLIDOCAINE HCLProdigy Media Inc6abe4540-f6c9-412a-83f3-682df77150572025-09-17WarningsExact identifier
application number: M017
Dr Tatty NumbingLIDOCAINE HCLProdigy Media Inc5bb558c1-bf8f-4956-8732-e19720f62f312025-09-17WarningsExact identifier
application number: M017
Burn Ease CoolingLIDOCAINEProStat First Aid LLCec201ca1-efa0-4797-aec3-115647c29abd2025-09-17WarningsExact identifier
application number: M017
MedFreeze Naturally Cool Pain ReliefMENTHOLMEDKO LLC240f2346-c585-4334-997c-45db6268d7c42025-09-15WarningsExact identifier
application number: M017
MEDISTIK DUAL HOT AND COLDMETHYL SALICYLATE, MENTHOLNatureteq Inc.ba5f4626-f077-4a28-8dcc-dacd50741ead2025-09-15WarningsExact identifier
application number: M017
MEDISTIK ICEMENTHOL, CAMPHORNatureteq Inc.c1077744-7b9a-4536-8faf-e21994a43ea52025-09-15WarningsExact identifier
application number: M017
Caring Mills Vaginal Anti-Itch CreamBENZOCAINE, RESORCINOLVeridian Healthcarecd379e74-2841-47e4-b95a-de1b341b397f2025-09-15WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42086-052-01420860052011000 TUBE in 1 PACKAGE (42086-052-01) / 7.1 g in 1 TUBE1000 tube2026-05-31NoNoCurrent
42086-052-0242086005202720 TUBE in 1 PACKAGE (42086-052-02) / 17 g in 1 TUBE720 tube2026-05-31NoNoCurrent
42086-052-0342086005203720 TUBE in 1 PACKAGE (42086-052-03) / 24 g in 1 TUBE720 tube2026-05-31NoNoCurrent
42086-052-0442086005204144 TUBE in 1 PACKAGE (42086-052-04) / 43 g in 1 TUBE144 tube2026-05-31NoNoCurrent
42086-052-0542086005205144 TUBE in 1 PACKAGE (42086-052-05) / 78 g in 1 TUBE144 tube2026-05-31NoNoCurrent
42086-052-064208600520660 TUBE in 1 PACKAGE (42086-052-06) / 130 g in 1 TUBE60 tube2026-05-31NoNoCurrent
42086-052-074208600520760 TUBE in 1 PACKAGE (42086-052-07) / 181 g in 1 TUBE60 tube2026-05-31NoNoCurrent