FDA.reportPublic FDA data

Sensitivity Relief Fluoride Free

Product NDC
63404-2105
11-digit product format
634042105
Labeler code
63404
Product ID
63404-2105_8b7a44b8-4906-41dd-a8ec-a56eb779c899
Type
HUMAN OTC DRUG
Nonproprietary name
Potassium Nitrate
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Health and Natural Beauty USA Corp
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-01-01
Substance
POTASSIUM NITRATE
Active strength
50 mg/g
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
Sensitivity Relief Fluoride Free
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM NITRATE50 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312544Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c23b2a83-ebc3-4bcf-a216-7693944dcfa0Available on FDA.report

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63404-2105-1634042105011 TUBE in 1 CARTON (63404-2105-1) / 100 g in 1 TUBE1 tube2018-01-01NoNoCurrent