FDA.reportPublic FDA data

Orajel Sensitivity Relief

Product NDC
10237-678
11-digit product format
102370678
Labeler code
10237
Product ID
10237-678_88d71cb7-8abf-407d-a74c-f5537497759a
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride and Potassium Nitrate
Dosage form
PASTE, DENTIFRICE
Route
ORAL
Labeler
Church & Dwight Co., Inc.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-31
Substance
SODIUM FLUORIDE; POTASSIUM NITRATE
Active strength
.243; 5 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
Orajel Sensitivity Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE.243 g/100g
POTASSIUM NITRATE5 g/100g

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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7b9d9e7d-3844-4d18-ab03-bd0e9dcfccdbAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10237-678-12Orajel Sensitivity Relief2 in 1 CARTONPASTE, DENTIFRICE22
10237-678-12Orajel Sensitivity Relief170 g in 1 TUBEPASTE, DENTIFRICE1702
10237-678-43Orajel Sensitivity Relief121.9 g in 1 TUBEPASTE, DENTIFRICE121.92

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10237-678ORAJEL SENSITIVITY RELIEF (SODIUM FLUORIDE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [CHURCH & DWIGHT CO., INC.]2Current NDC, 3 package rows20240404_7b9d9e7d-3844-4d18-ab03-bd0e9dcfccdb.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 31 of 51 · 1,013 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sensodyne Pronamel Kids Bubble MintSODIUM FLUORIDEHaleon US Holdings LLC41b1e626-e79b-d638-e063-6394a90a1f5b2025-12-15WarningsExact identifier
application number: M021
Simple Truth Kids FlourideSODIUM MONOFLUOROPHOSPHATEKroger Company82b9db89-d108-3f64-e053-2991aa0aee742025-12-15WarningsExact identifier
application number: M021
Natural Adult FluorideSODIUM MONOFLUOROPHOSPHATEKrogera71c537e-39d9-1c3b-e053-2a95a90ac3ec2025-12-15WarningsExact identifier
application number: M021
Therabreath Overnight Chamomile MintSODIUM FLUORIDEChurch & Dwight Co., Inc.cc0c533c-145e-4877-b421-1baf3a3a572e2025-12-11WarningsExact identifier
application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE BUBBLEGUMSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.188d28f9-a814-0f98-e063-6294a90a106b2025-12-11WarningsExact identifier
application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE WATERMELONSODIUM FLUORIDEKingkey MBC Life Technology Group Co.,Ltd1b4cf935-38a6-f4fb-e063-6394a90a4bc02025-12-11Exact identifier
application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE WATERMELONSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.188cddb2-c799-0897-e063-6294a90a5d962025-12-11WarningsExact identifier
application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE BUBBLEGUMSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD1ba491f4-2ad2-6e7b-e063-6394a90a9fb72025-12-11WarningsExact identifier
application number: M021
BRUSH BUDDIES HOTWHEEL ANTICAVITY FLUORIDE STRAWBERRYSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.188ac743-3ba8-4da4-e063-6294a90a8f872025-12-11WarningsExact identifier
application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRYSODIUM FLUORIDEKingkey MBC Life Technology Group Co.,Ltd1b682604-c563-01f1-e063-6294a90ab0bd2025-12-11Exact identifier
application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRYSODIUM FLUORIDEKingkey MBC Life Technology Group Co.,Ltd1b110db1-fcc0-377f-e063-6394a90a4d442025-12-11Exact identifier
application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE WATERMELONSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD1b74ecc4-a1e6-348f-e063-6294a90a58942025-12-11Exact identifier
application number: M021
BRUSH BUDDIES BRBIE ANTICAVITY FLUORIDE BUBBLEGUMSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.1b68315c-6afa-3f37-e063-6294a90a14e82025-12-11WarningsExact identifier
application number: M021
ANTICAVITY FLUORIDESODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD295b88e8-c4b5-c0b0-e063-6394a90aca012025-12-11WarningsExact identifier
application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE BUBBLEGUMSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD1b74f072-c33b-c6e2-e063-6394a90ab1e62025-12-11WarningsExact identifier
application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRYSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD1ba4a807-d6d5-04a0-e063-6294a90ae04d2025-12-11Exact identifier
application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRYSODIUM FLUORIDEKingkey MBC Life Technology Group Co.,Ltd1b617f4a-b56c-9f75-e063-6294a90a7abe2025-12-11Exact identifier
application number: M021
BRUSH BUDDIES BRBIE ANTICAVITY FLUORIDE BUBBLEGUMSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.1b9ec370-eadf-92c4-e063-6294a90a90552025-12-11WarningsExact identifier
application number: M021
BRUSH BUDDIES SQUISHMALLOWS ANTICAVITY FLUORIDE MINT FALVORSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD1eb04296-ecb1-3ccc-e063-6294a90a9bda2025-12-11WarningsExact identifier
application number: M021
BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE STRAWBERRYSODIUM FLUORIDEKingkey MBC Life Technology Group Co.,Ltd1b9e7b21-0d34-74ec-e063-6294a90a1f592025-12-11Exact identifier
application number: M021

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10237-678-12102370678122 TUBE in 1 CARTON (10237-678-12) / 170 g in 1 TUBE2 tube2024-06-01NoNoCurrent
10237-678-4310237067843121.9 g in 1 TUBE (10237-678-43) 121.9 g2024-01-31NoNoCurrent