FDA.reportPublic FDA data

UNIVERSAL SENSITIVE ANTI-CAVITY FLUORIDE

Product NDC
52000-109
Requested package NDC
52000-109-01
11-digit product format
520000109
Labeler code
52000
Product ID
52000-109_1199f2f8-98e4-4b76-9be9-3b921495a3c3
Type
HUMAN OTC DRUG
Nonproprietary name
potassium nitrate and sodium fluoride
Dosage form
PASTE
Route
DENTAL
Labeler
Universal Distribution Center LLC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-05-20
Substance
POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength
5; .15 g/100g; 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
UNIVERSAL SENSITIVE ANTI-CAVITY FLUORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM NITRATE5 g/100g
SODIUM FLUORIDE.15 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
RU45X2JN0ZInternal UNII lookup
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1038841Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fcf59439-7e06-4129-a89f-cdeecdf8d488Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52000-109-01UNIVERSAL SENSITIVE ANTI-CAVITY FLUORIDE122 g in 1 TUBEPASTE1222

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52000-109UNIVERSAL SENSITIVE ANTI-CAVITY FLUORIDE (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [UNIVERSAL DISTRIBUTION CENTER LLC]2Current NDC, Legacy NDC, 1 package rows20231121_fcf59439-7e06-4129-a89f-cdeecdf8d488.zip

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
1038841potassium nitrate 5 % / sodium fluoride 0.15 % ToothpastePSNfcf59439-7e06-4129-a89f-cdeecdf8d4882
1038841potassium nitrate 0.05 MG/MG / sodium fluoride 0.0015 MG/MG ToothpasteSCDfcf59439-7e06-4129-a89f-cdeecdf8d4882
1038841K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0015 MG/MG ToothpasteSYfcf59439-7e06-4129-a89f-cdeecdf8d4882
1038841pot nitrate 0.05 MG/MG / sodium fluoride 0.0015 MG/MG gel ToothpasteSYfcf59439-7e06-4129-a89f-cdeecdf8d4882
1038841Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0015 MG/MG ToothpasteSYfcf59439-7e06-4129-a89f-cdeecdf8d4882
1038841potassium nitrate 5 % / sodium fluoride 0.15 % ToothpasteSYfcf59439-7e06-4129-a89f-cdeecdf8d4882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52000-109-0152000010901122 g in 1 TUBE (52000-109-01) 122 g2020-05-200000-00-00NoNoCurrent