Home NDC 10237-678 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 Ingredient Strength SODIUM FLUORIDE .243 g/100g POTASSIUM NITRATE 5 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8ZYQ1474W7 Internal UNII lookup RU45X2JN0Z Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 10237-678-12 Orajel Sensitivity Relief 2 in 1 CARTON PASTE, DENTIFRICE 2 2 10237-678-12 Orajel Sensitivity Relief 170 g in 1 TUBE PASTE, DENTIFRICE 170 2 10237-678-43 Orajel Sensitivity Relief 121.9 g in 1 TUBE PASTE, DENTIFRICE 121.9 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10237-678 ORAJEL SENSITIVITY RELIEF (SODIUM FLUORIDE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [CHURCH & DWIGHT CO., INC.] 2 Current NDC, 3 package rows 20240404_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 38 of 51 · 1,013 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Dubai Chocolate Fluoride Mouthwash ANTICAVITY MOUTHWASH SuperMouth, LLC. ef81a983-64c1-4913-9235-25451f023852 2025-07-23 Warnings Exact identifier application number: M021 ACT Restoring Anticavity Fluoride Cool Mint SODIUM FLUORIDE Chattem, Inc. 3409a749-4a1a-4950-8c21-364d1b977af7 2025-07-22 Warnings Exact identifier application number: M021 Act Total Care Anticavity Fluoride Fresh Mint SODIUM FLUORIDE Chattem, Inc. dc209500-2bf4-42fb-b3a1-d0fb8d63dbd8 2025-07-22 Warnings Exact identifier application number: M021 Brush Buddies Oral Rinse Sparkle Mint SODIUM FLUORIDE ASHTEL STUDIOS, INC fe2c06fc-6497-4888-877f-1a88e02fad20 2025-07-15 Warnings Exact identifier application number: M021 evo SENSITIVE WHITENING ANTI-CAVITY FLUORIDE SODIUM FLUORIDE Ashtel Studios, Inc. 1620c7fa-2af6-4462-af5d-9e122942788a 2025-07-15 Warnings Exact identifier application number: M021 Dentalclean Green Diamond Alcohol Free Mouthwash SODIUM FLUORIDE 0.05% Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda 5653aa33-4f0e-46b2-9be0-6219143556ec 2025-07-14 Warnings Exact identifier application number: M021 Colgate Total Gum Protect Fresh Mint STANNOUS FLUORIDE COLGATE PALMOLIVE COMPANY 570e3bd6-eede-4270-9d78-055aeb2b8c17 2025-07-14 Warnings Exact identifier application number: M021 OraPro Fluoride Anticavity FLUORIDE TOOTHPASTE Protegera, Inc. 93b0181c-e29f-42f4-80f5-366463b68f09 2025-07-10 Warnings Exact identifier application number: M021 Enamur Fluoride AntiCavity Toothpast FLUORIDE TOOTHPAST Protegera, Inc 557ced45-f54e-43d8-aa13-46f75b79367c 2025-07-10 Warnings Exact identifier application number: M021 Super Strawberry STRAWBERRY TOOTHPASTE SuperMouth, LLC. a8c2b68d-d28b-41c0-a383-cc706b25aa1a 2025-07-05 Warnings Exact identifier application number: M021 Super Mint SUPER MINT TOOTHPASTE SuperMouth, LLC. be0915f3-36c4-4200-9d15-704cfbd632b4 2025-07-05 Warnings Exact identifier application number: M021 Super Vanilla VANILLA TOOTHPASTE SuperMouth, LLC. 3ddfe20a-86f1-4566-bb77-82c9749411f6 2025-07-05 Warnings Exact identifier application number: M021 Super Chocolate CHOCOLATE TOOTHPASTE SuperMouth, LLC. 48607622-7c5e-4ddc-8d83-707f26c0553f 2025-07-05 Warnings Exact identifier application number: M021 Brush Buddies ADVANCED WHITENING ANTI-CAVITY FLUORIDE PEPPERMINT SODIUM FLUORIDE Ashtel Studios, Inc. 13dba3ce-88a8-490c-a906-cfd206d1d290 2025-07-01 Warnings Exact identifier application number: M021 evo ADVANCED WHITENING ANTI-CAVITY FLUORIDE PEPPERMINT SODIUM FLUORIDE Ashtel Studios, Inc. baae4f4a-54ef-472a-9c94-31703435750b 2025-07-01 Warnings Exact identifier application number: M021 CURODONT REPAIR FLUORIDE PLUS SODIUM FLUORIDE CREDENTIS AG 290c57b0-a562-0a51-e063-6294a90a0720 2025-06-23 Warnings Exact identifier application number: M021 KarlnHans Fresh Breath Jasmine Mint SODIUM MONOFLUOROPHOSPHATE PIGEON CORPORATION 384863bd-b2cb-a46d-e063-6394a90a3ce2 2025-06-23 Warnings Exact identifier application number: M021 KarlnHans Fresh Breath Double Mint SODIUM MONOFLUOROPHOSPHATE PIGEON CORPORATION 38487130-9508-a2c4-e063-6394a90aa323 2025-06-23 Warnings Exact identifier application number: M021 Crest Kids SparkleFun Bubblegum SODIUM FLUORIDE Procter & Gamble Manufactura, S. de R.L. de C.V. 01f0e81a-03bf-e17f-e063-6394a90a7358 2025-06-12 Warnings Exact identifier application number: M021 Freshen Up SODIUM FLUORIDE, POTASSIUM NITRATE MKJ BRANDS LLC 2ee626d1-6150-87db-e063-6294a90a64d8 2025-06-12 Warnings Exact identifier application number: M021
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 10237-678-12 10237067812 2 TUBE in 1 CARTON (10237-678-12) / 170 g in 1 TUBE 2 tube 2024-06-01 No No Current 10237-678-43 10237067843 121.9 g in 1 TUBE (10237-678-43) 121.9 g 2024-01-31 No No Current