FDA.reportPublic FDA data

Charm Tex FLUORIDE

Product NDC
71035-001
Requested package NDC
71035-001-01
11-digit product format
710350001
Labeler code
71035
Product ID
71035-001_3ca5d2b2-d884-a6b1-e063-6394a90a970d
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM MONOFLUOROPHOSPHATE
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 MONOFLUOROPHOSPHATE
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM MONOFLUOROPHOSPHATE.1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
C810JCZ56QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
545626Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
63a69664-8611-4d69-b871-8d1d5b553e5cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71035-001-01Charm Tex FLUORIDE720 in 1 PACKAGEPASTE, DENTIFRICE7202
71035-001-01Charm Tex FLUORIDE17 g in 1 TUBEPASTE, DENTIFRICE172
71035-001-02Charm Tex FLUORIDE24 g in 1 TUBEPASTE, DENTIFRICE242
71035-001-02Charm Tex FLUORIDE720 in 1 PACKAGEPASTE, DENTIFRICE7202
71035-001-03Charm Tex FLUORIDE43 g in 1 TUBEPASTE, DENTIFRICE432
71035-001-03Charm Tex FLUORIDE144 in 1 PACKAGEPASTE, DENTIFRICE1442
71035-001-04Charm Tex FLUORIDE78 g in 1 TUBEPASTE, DENTIFRICE782
71035-001-04Charm Tex FLUORIDE144 in 1 PACKAGEPASTE, DENTIFRICE1442
71035-001-05Charm Tex FLUORIDE130 g in 1 TUBEPASTE, DENTIFRICE1302
71035-001-05Charm Tex FLUORIDE60 in 1 PACKAGEPASTE, DENTIFRICE602
71035-001-06Charm Tex FLUORIDE181 g in 1 TUBEPASTE, DENTIFRICE1812
71035-001-06Charm Tex FLUORIDE60 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 1 of 41 · 818 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CrystLCare Regeneration PlusPOTASSIUM NITRATE, SODIUM FLUORIDEGreenMark Biomedical Inc.4f86d0a0-d73e-5605-e063-6394a90adb382026-09-14WarningsExact identifier
application number: M022
Opalescence Whitening Sensitivity ReliefPOTASSIUM NITRATE AND SODIUM FLUORIDEUltradent Products, Inc.44e94663-895b-67da-e063-6394a90a5fe62026-09-09WarningsExact identifier
application number: M022
Opalescence Sensitivity Relief WhiteningPOTASSIUM NITRATE AND SODIUM FLUORIDEUltradent Products, Inc.b5176a84-76a3-4ad0-a2e2-4997a12da9a52026-09-09WarningsExact identifier
application number: M022
Opal by Opalescence SensitivityPOTASSIUM NITRATE AND SODIUM FLUORIDEUltradent Products, Inc.5ffc0d14-0290-47bb-90e5-90a25a5acc282026-09-09WarningsExact identifier
application number: M022
SalineNASALRaritan Pharmaceuiticals Inc4b178e4e-a10f-4b75-8140-1f7548e203ad2026-09-09WarningsExact identifier
application number: M022
SORE THROATPHENOLRaritan Pharmaceuticals Inc43ce374a-824c-4034-bf04-c351b4d8015b2026-09-08WarningsExact identifier
application number: M022
Colgate Optic White Stain Fighter Sens ReliefSODIUM FLUORIDEColgate-Palmolive Company6ec2fff7-df44-4302-be2d-97946c6cd66a2026-09-08WarningsExact identifier
application number: M022
DRx Choice Sore Throat Menthol FlavorPHENOLRARITAN PHARMACEUTICALS INCe3269b12-5c05-45a6-81f2-65d9f016c3aa2026-09-08WarningsExact identifier
application number: M022
Hydrogen PeroxideHYDROGEN PEROXIDEAmerisourceBergen (Good Neighbor Pharmacy) 461220733015b-e81a-4a62-82ad-dacaf3f163cb2026-09-02WarningsExact identifier
application number: M022
KROGER SalineNASALKROGER COMPANYc84b242b-f46e-4ea8-a3c1-109a476446462026-09-02WarningsExact identifier
application number: M022
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWALMART INC. (see also Equate)ceb125d9-8c1b-498c-b0f0-f18756ede4422026-09-01WarningsExact identifier
application number: M022
Orajel 4X Medicated Toothache and Gum CreamBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1c82b4-02b3-d456-e063-6294a90a16bb2026-08-31WarningsExact identifier
application number: M022
Orajel 4X Medicated Toothache and Gum PM CreamBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1cdaf4-3388-280c-e063-6294a90ac70f2026-08-31WarningsExact identifier
application number: M022
MUCINEX INSTASOOTHE SORE THROAT PLUS SOOTHING COMFORTHEXYLRESORCINOLReckitt Benckiser LLC91cd2964-5d83-4e40-bc18-e3e5462f454a2026-08-31WarningsExact identifier
application number: M022
MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEFHEXYLRESORCINOLReckitt Benckiser LLC4c150222-06ea-4fcf-967f-84e19846bd662026-08-31WarningsExact identifier
application number: M022
Orajel 4X Medicated Toothache and GumBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1b4133-0eac-2f8f-e063-6394a90af8f62026-08-28WarningsExact identifier
application number: M022
LUDENS SUGAR FREE WILD CHERRY THROATPECTINPrestige Brands Holdings, Inc.274fc80c-e5b2-41c7-a119-287d6e8a22582026-08-28WarningsExact identifier
application number: M022
Medline Peroxi Fresh MouthwashHYDROGEN PEROXIDEMedline Industries, LPec7a9240-6c66-4471-b8b6-776e08a14fbc2026-08-27WarningsExact identifier
application number: M022
SalineSALINE NASAL SPRAYDynarex Corporation3247ae7d-554f-baab-e063-6294a90aa3ec2026-08-25WarningsExact identifier
application number: M022
Tumeez Organic AppleCALCIUM CARBONATEBFY LLCf561685a-5260-59c6-e053-2a95a90ae2062026-08-25WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN63a69664-8611-4d69-b871-8d1d5b553e5c2
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD63a69664-8611-4d69-b871-8d1d5b553e5c2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY63a69664-8611-4d69-b871-8d1d5b553e5c2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY63a69664-8611-4d69-b871-8d1d5b553e5c2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY63a69664-8611-4d69-b871-8d1d5b553e5c2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY63a69664-8611-4d69-b871-8d1d5b553e5c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71035-001-0171035000101720 TUBE in 1 PACKAGE (71035-001-01) / 17 g in 1 TUBE720 tube2025-06-13NoNoCurrent