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 10 of 51 · 1,013 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
White Glo Purple Color Corrector Fluoride AnticavitySODIUM MONOFLUOROPHOSPHATEWhite Glo USA Inc6f8b77c3-9833-4c75-b41c-a2bc126161572026-05-12WarningsExact identifier
application number: M021
botalab HERBAL COMPLETE TOOTHSODIUM FLUORIDEKMPHARMACEUTICAL CO., LTD.51365ef7-ed94-2650-e063-6394a90ab89e2026-05-07WarningsExact identifier
application number: M021
Morning Fresh Mint Toothpaste, with FluorideMORNING FRESH MINT TOOTHPASTE, WITH FLUORIDEDynarex Corporation2a42d8ce-e7f2-caa5-e063-6294a90ac01f2026-05-07WarningsExact identifier
application number: M021
Frida Fluoride Sweet MintSODIUM FLUORIDEFridababy, LLC4f8b5a39-5d79-72cd-e063-6394a90a475c2026-05-06WarningsExact identifier
application number: M021
Frida Fluoride Bubble MintSODIUM FLUORIDEFridababy, LLC4f8b9af3-e4b3-b5e0-e063-6394a90a10682026-05-06WarningsExact identifier
application number: M021
Frida Fluoride Strawberry Toothbrush SetSODIUM FLUORIDEFridababy, LLC4f8ba14f-60ea-c2a8-e063-6394a90a77022026-05-06WarningsExact identifier
application number: M021
Frida Fluoride StrawberrySODIUM FLUORIDEFridababy, LLC4f814a62-8f91-8ea6-e063-6294a90a69eb2026-05-06WarningsExact identifier
application number: M021
Gum Health DetoxifySTANNOUS FLUORIDEMeijer, Inc41d70733-a223-40fb-e063-6294a90a13972026-05-06WarningsExact identifier
application number: M021
Colgate Kids Unicorn Alcohol FreeSODIUM FLUORIDEColgate-Palmolive Company133acaff-7205-80d7-e91d-3eb37087cae42026-05-05WarningsExact identifier
application number: M021
Crest 3D White Stain EraserSODIUM FLUORIDEProcter & Gamble Manufactura, S. de R.L. de C.V.fdefffbd-9c05-fa30-e053-6394a90a34bc2026-05-05WarningsExact identifier
application number: M021
Frida Fluoride WatermelonSODIUM FLUORIDEFridababy, LLC4f8b49dc-e9e4-c341-e063-6294a90adb5a2026-05-05WarningsExact identifier
application number: M021
White Glo Extreme White WhiteningSODIUM MONOFLUOROPHOSPHATEWhite Glo USA Inc4a2e0a8d-420e-4c07-aa43-386d05dab4722026-04-30WarningsExact identifier
application number: M021
Equate Pro-Advanced TP Equate Pro-Advanced TPSTANNOUS FLUORIDEWalmart Inc.1e6561fb-4e3b-40ba-e063-6294a90a26902026-04-29WarningsExact identifier
application number: M021
Crest Cavity Protection RegularSODIUM FLUORIDEProcter & Gamble Manufactura, S. de R.L. de C.V.852889b4-59ba-4592-b4fc-c0127a1ad0752026-04-28WarningsExact identifier
application number: M021
Crest Complete Multi-Benefit Whitening plus ScopeSODIUM FLUORIDEProcter & Gamble Manufactura, S. de R.L. de C.V.0206710a-707f-4aa9-96b9-86240c1275dc2026-04-28WarningsExact identifier
application number: M021
Alcohol Free Refreshing MintSODIUM FLUORIDEH E Bcedf7c08-7412-4733-9b67-225b331cec8c2026-04-27Warnings, Adverse reactionsExact identifier
application number: M021
anzoon ANTIBACTERIAL MOUTH WASHCETYLPYRIDINIUM CHLORIDEShandong AZC Biotechnology Co.,Ltd.507c6896-2806-790c-e063-6394a90ac5ce2026-04-27WarningsExact identifier
application number: M021
DELTA COMFORT PLUS AMENITYSODIUM MONOFLUOROPHOSPHATEBuzz Products Inc.26434794-ae02-0f58-e063-6294a90ad85e2026-04-24WarningsExact identifier
application number: M021
A and H Plus Therabreath Breath FreshnersSODIUM FLUORIDEChurch & Dwight Co., Inc.18d6073e-b1ee-47d2-9758-2cf04f3cf3ca2026-04-23WarningsExact identifier
application number: M021
FluorideSODIUM FLUORIDEMcKesson5025e58e-e59c-07b6-e063-6394a90ac1e82026-04-23WarningsExact 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