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 36 of 51 · 1,013 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MediChoice FluorideSODIUM MONOFLUOROPHOSPHATEO&M HALYARD, INC.a87956fa-8975-4a44-9e9a-4b2191e401fe2025-10-09WarningsExact identifier
application number: M021
BRUSH BUDDIES BARBIE ANTICAVITY FLUORIDE BUBBLEGUMSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.1b6f893d-74ac-421e-a78b-f495ac425af02025-10-09WarningsExact identifier
application number: M021
BRUSH BUDDIES HOTWHEEL ANTICAVITY FLUORIDE STRAWBERRYSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.a3e989f8-e6a2-4e13-8faa-77e95895166d2025-10-09WarningsExact identifier
application number: M021
TARGET UP AND UP ANTICAVITYSODIUM FLUORIDE 0.05%TARGET CORPORATION2992efce-1c66-df40-e063-6294a90ab3c02025-10-08WarningsExact identifier
application number: M021
MediChoice Premium Anticavity FluorideSODIUM FLUORIDEO&M HALYARD, INC.c6ba9b51-b958-4836-adc8-871529a43fc62025-10-08WarningsExact identifier
application number: M021
TidaloveSPICY CINNAMON TOOTHPASTE TABLETSParanmare LLC4092fcbf-27f7-b067-e063-6394a90a41c62025-10-07WarningsExact identifier
application number: M021
TidaloveCOOL MINT TOOTHPASTE TABLETSParanmare LLC4093060c-23a5-c77a-e063-6394a90a93042025-10-07WarningsExact identifier
application number: M021
TidaloveYUZU MINT TOOTHPASTE TABLETSParanmare LLC40946943-21cf-b114-e063-6394a90aed3f2025-10-07WarningsExact identifier
application number: M021
Optimax Purple Anticavity FluorideSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCfdb16e59-5be1-4bd0-a940-d542d67fb2df2025-10-02WarningsExact identifier
application number: M021
Intensive Enamel Repair Whitening TPINTENSIVE ENAMEL REPAIR WHITENING TPTopco Associates LLC3012a8da-7595-2f7c-e063-6294a90ae1202025-09-30WarningsExact identifier
application number: M021
Made by Dentists For Kids Eyeball Juice (Watermelon)SODIUM FLUORIDEMADE BY DENTISTS INCb2ad2b19-6fdf-454d-9b1d-49b1c81016fd2025-09-30WarningsExact identifier
application number: M021
ACT Restoring Anticavity Fluoride Mint BurstSODIUM FLUORIDEChattem, Inc.a38363e6-7105-4663-95a0-09ecb2948f832025-09-30WarningsExact identifier
application number: M021
UNPA CHA CHA TOOTHPASTESODIUM MONOFLUOROPHOSPHATEDONG IL PHARMS CO.,LTD3fae966e-0246-b9f2-e063-6394a90a494c2025-09-26WarningsExact identifier
application number: M021
Cloveden ToothSODIUM MONOFLUOROPHOSPHATEDONG IL PHARMS CO.,LTD3fb01bea-7205-49ba-e063-6294a90a38412025-09-26WarningsExact identifier
application number: M021
Cloveden Sensitive Care ToothSODIUM FLUORIDEDONG IL PHARMS CO.,LTD3fb153f1-ba6e-7251-e063-6294a90abe622025-09-26WarningsExact identifier
application number: M021
Cloveden 100 times higher concentratedCETYLPYRIDINIUM CHLORIDEDONG IL PHARMS CO.,LTD3fb1a2ee-381e-a9e8-e063-6394a90a864b2025-09-26WarningsExact identifier
application number: M021
unpa Cha Cha ToothpasteSODIUM MONOFLUOROPHOSPHATELycl Inc.230b3cf2-053a-4e8b-8d50-05bbc877faa82025-09-25WarningsExact identifier
application number: M021
TheraBreath AnticavitySODIUM FLUORIDEChurch & Dwight Co., Inc.3c5d58f1-ea8c-4708-bbc6-21e1cd1446da2025-09-19WarningsExact identifier
application number: M021
Optimax Professional Whitening Anticavity FluorideSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INC8c4b9db9-8f23-4dd5-ab6e-1c2f9a3da5b12025-09-18WarningsExact identifier
application number: M021
Optimax Professional Whitening Anticavity FluorideSODIUM MONOFLUOROPHOSPHATEWHITE GLO USA INCc1bbdd36-53fb-43a3-ba20-afbeb6359d312025-09-18WarningsExact 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