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 14 of 51 · 1,013 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anticavity RinseSODIUM FLUORIDEAmazon.com Services LLC90d57288-711e-4d5e-8c9d-db7a4456a2562026-03-03Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEAmazon.com Services LLCf275755f-7879-4ca1-ae03-fa709e88cdad2026-03-03Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEAmazon.com Services LLC4a0220f8-748f-4a4a-9a8b-948756468f822026-03-03Warnings, Adverse reactionsExact identifier
application number: M021
Alcohol-Free AnticavitySODIUM FLUORIDEAmazon.com Services LLC349eca80-2e0c-409b-af29-3235fdc0695b2026-03-03Warnings, Adverse reactionsExact identifier
application number: M021
Oral AntivavitySODIUM FLUORIDEAmazon.com Services LLC03735abc-d1be-4ca0-a497-0a5c5f2894022026-03-03Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEOld East Main Co.f8036e2e-7541-4922-92b9-0d8319f7b64c2026-03-02Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEOld East Main Co.64f3d92d-f58c-4bc2-8819-f91492221ddb2026-03-02Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEOld East Main Co.c7b9e9cd-3cf7-4657-83c9-e221e1c359772026-03-02Warnings, Adverse reactionsExact identifier
application number: M021
Instant WhiteningINSTANT WHITENING TOOTHPASTEGuangzhou City Caiye Cosmetics CO., Ltd2807ece8-a1a5-b626-e063-6394a90aac622026-03-02WarningsExact identifier
application number: M021
Coffe Tea Stain Remover ToothCOFFE TEA STAIN REMOVER TOOTHPASTEGuangzhou City Caiye Cosmetics CO., Ltd2845d7af-7a0b-9bc8-e063-6294a90ac8b32026-03-02WarningsExact identifier
application number: M021
Professional whitening toothPROFESSIONAL WHITENING TOOTHPASTEGuangzhou City Caiye Cosmetics CO., Ltd291eba71-14da-fac3-e063-6294a90aa3cc2026-03-02WarningsExact identifier
application number: M021
purple toothPURPLE TOOTHPASTEGuangzhou City Caiye Cosmetics CO., Ltd291f0312-238c-71d5-e063-6294a90a39e12026-03-02WarningsExact identifier
application number: M021
Professional ChoicePROFESSIONAL CHOICE TOOTHPASTEGuangzhou City Caiye Cosmetics CO., Ltd28406739-6a8c-1ce8-e063-6394a90a08f82026-03-02WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEThe Kroger Co.27a98b64-8369-4f3d-b487-d7ce98abc69f2026-02-27Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEThe Kroger Co.390dd1b5-2dd1-4b55-b4b3-e441ada612382026-02-27Warnings, Adverse reactionsExact identifier
application number: M021
Alcohol-Free AnticavitySODIUM FLUORIDEThe Kroger Co.5459eeee-adf0-4afe-b190-62d4fa1138062026-02-27Warnings, Adverse reactionsExact identifier
application number: M021
Oral AntivavitySODIUM FLUORIDEThe Kroger Co.932723b8-9875-4f37-8c11-018c94ae0ae12026-02-27Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEThe Kroger Co.d0c552d8-44ad-4d95-b3fb-17015f44b3342026-02-27Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity RinseSODIUM FLUORIDEWalmart Inc.3beb65e4-ae8e-4e51-b9ba-181cbec41eff2026-02-27Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEWalmart Inc.61669087-0af6-4192-b514-afcfe7d8ba982026-02-27Warnings, Adverse reactionsExact 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