FDA.reportPublic FDA data

Sensitive Teeth and Gums

Product NDC
10237-669
11-digit product format
102370669
Labeler code
10237
Product ID
10237-669_574c1371-6ae8-fd05-e063-6394a90a9e0e
Type
HUMAN OTC DRUG
Nonproprietary name
Potassium Nitrate, Sodium Fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
Church & Dwight Co., Inc.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-10-16
Substance
SODIUM FLUORIDE; POTASSIUM NITRATE
Active strength
2.43; 50 mg/g; 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
Sensitive Teeth and Gums
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE2.43 mg/g
POTASSIUM NITRATE50 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1038929Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
935172db-d78f-0c69-e053-2a95a90a0b69Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10237-669-09Sensitive Teeth and Gums25 g in 1 TUBEPASTE, DENTIFRICE254
10237-669-09Sensitive Teeth and Gums1 in 1 CARTONPASTE, DENTIFRICE14
10237-669-45Sensitive Teeth and Gums127 g in 1 TUBEPASTE, DENTIFRICE1274
10237-669-45Sensitive Teeth and Gums1 in 1 CARTONPASTE, DENTIFRICE14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10237-669SENSITIVE TEETH AND GUMS (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE, DENTIFRICE [CHURCH & DWIGHT CO., INC.]3Current NDC, Legacy NDC, 4 package rows20241123_935172db-d78f-0c69-e053-2a95a90a0b69.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 51 · 1,013 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COLGATE OPTIC WHITE STAIN FIGHTER FRESH MINTSODIUM FLUORIDEColgate-Palmolive Companyb1ef8277-9919-453c-9d21-da4666d952de2026-09-17WarningsExact identifier
application number: M021
TheraBreathSODIUM FLUORIDEChurch & Dwight Co., Inc.53c1086d-264b-9d00-e063-6394a90ad19d2026-09-09WarningsExact identifier
application number: M021
Opalescence Whitening Cool MintSODIUM FLUORIDEUltradent Products, Inc.44e7d0ed-3c37-5889-e063-6294a90afcca2026-09-09WarningsExact identifier
application number: M021
Opalescence WhiteningSODIUM FLUORIDEUltradent Products, Incd07f842e-b6f1-4ae1-b576-f542ecd02dd42026-09-09WarningsExact identifier
application number: M021
Opal by Opalescence OriginalSODIUM FLUORIDEUltradent Products, Inc.5c3bf8fc-2e8f-4a58-bcbf-e47540072a492026-09-09WarningsExact identifier
application number: M021
Opal by Opalescence CompleteOPAL BY OPALESCENCE COMPLETEUltradent Products, Inc.249cc46a-dad6-0345-e063-6394a90a44472026-09-09WarningsExact identifier
application number: M021
Colgate MaxFresh KnockoutSODIUM FLUORIDEColgate-Palmolive Company0ffbb3a9-7bfa-4f6a-aef3-fde327a410c92026-09-09WarningsExact identifier
application number: M021
Colgate MaxFresh CharcoalSODIUM FLUORIDEColgate-Palmolive Companyde3674f4-3ce6-47d5-8391-6ad6789d68d92026-09-09WarningsExact identifier
application number: M021
Freshmint Premium AnticavitySODIUM FLUORIDENew World Imports, Incef108fff-a79c-4e8d-8bf0-3fe567f93eb82026-09-08WarningsExact identifier
application number: M021
Freshmint Premium AnticavitySODIUM FLUORIDENew World Imports, Inc1a42cf2d-6c48-4e38-97bc-b6f2084bf39b2026-09-08WarningsExact identifier
application number: M021
Freshmint Premium Anticavity GelSODIUM FLUORIDENew World Imports, Incdfe564c1-2097-431d-93f0-cf423f2542482026-09-08WarningsExact identifier
application number: M021
Freshmint Anticavity FluorideSODIUM MONOFLUOROPHOSPHATENew World Imports, Inc5aff7e41-58cd-5ab8-e063-6294a90aa1c72026-09-08WarningsExact identifier
application number: M021
Colgate Optic White Advanced Sparkling WhiteSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companybc56603d-4190-48c1-b16e-3179a650cb392026-09-06WarningsExact identifier
application number: M021
Dentalclean Advanced ProSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda4d261dc8-b065-567f-e063-6294a90aa93f2026-09-04WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitude54bd43c9-489d-4e6b-9031-90ec0e3c45162026-09-01WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitude53c344e9-49f5-48aa-8309-1e15f80b80a02026-09-01WarningsExact identifier
application number: M021
UnpasteZERO WASTE FLUORIDE MINT TOOTH TABSAvespan LLC312ae88d-7ea4-b3e0-e063-6294a90a99e52026-09-01WarningsExact identifier
application number: M021
Dentalclean Regenerator Sensitive Dental Gel with FluorideSODIUM FLUORIDE 0.24%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda176aa3ed-e2a4-536d-e063-6294a90aa0972026-08-31WarningsExact identifier
application number: M021
Listerine Total Care Fresh Mint AnticavitySODIUM FLUORIDEKenvue Brands LLCb2ce66c3-dc48-47a5-a731-5550bc1946792026-08-28WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEYour Military Exchangescef74e9c-d3b5-4e92-9908-187be97b63ab2026-08-28Warnings, Adverse reactionsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSN935172db-d78f-0c69-e053-2a95a90a0b694
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCD935172db-d78f-0c69-e053-2a95a90a0b694
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY935172db-d78f-0c69-e053-2a95a90a0b694
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY935172db-d78f-0c69-e053-2a95a90a0b694
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY935172db-d78f-0c69-e053-2a95a90a0b694
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY935172db-d78f-0c69-e053-2a95a90a0b694
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSY935172db-d78f-0c69-e053-2a95a90a0b694

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10237-669-09102370669091 TUBE in 1 CARTON (10237-669-09) / 25 g in 1 TUBE1 tube2019-02-15NoNoCurrent
10237-669-42102370669422 TUBE in 1 CARTON (10237-669-42) / 127 g in 1 TUBE2 tube2026-02-20NoNoCurrent
10237-669-44102370669444 CARTON in 1 PACKAGE (10237-669-44) / 1 TUBE in 1 CARTON / 127 g in 1 TUBE4 carton2026-07-03NoNoCurrent
10237-669-45102370669451 TUBE in 1 CARTON (10237-669-45) / 127 g in 1 TUBE1 tube2017-10-160000-00-00NoNoCurrent