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 22 of 51 · 1,013 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ACT Total Care Dry Mouth Anticavity Mouth SODIUM FLUORIDE Chattem, Inc. 06684b82-aaa0-4ca6-8d56-4f9866269000 2026-01-12 Warnings Exact identifier application number: M021 ACT Anticavity Fluoride Kids Groovy Grape SODIUM FLUORIDE Chattem, Inc. cd167c0b-2086-4204-b0ac-90df404bd4bb 2026-01-12 Warnings Exact identifier application number: M021 ACT Total Care Anticavity Fluoride Icy Clean Mint SODIUM FLUORIDE Chattem, Inc. beded786-bb55-4ba3-82fe-9e9d1b5e2979 2026-01-12 Warnings Exact identifier application number: M021 ACT Kids Pure Protect Anticavity- Simply Strawberry SODIUM FLUORIDE Chattem, Inc. 2fc80727-57c7-4a33-80e0-ab9f9487390d 2026-01-12 Warnings Exact identifier application number: M021 ACT Kids Anticavity Fluoride Groovy Grape SODIUM FLUORIDE Chattem, Inc. 310a3c11-1c66-4dac-99f4-5fdc15d0f77c 2026-01-12 Warnings Exact identifier application number: M021 ACT Anticavity Fluoride Kids Bubblegum SODIUM FLUORIDE Chattem, Inc. fbbccd58-a816-4a93-a658-f28246c11e80 2026-01-12 Warnings Exact identifier application number: M021 ACT Whitening Anticavity Gentle Mint SODIUM FLUORIDE 0.02 (0.009 W/V FLUORIDE ION) Chattem, Inc. cd45a0b8-9ab3-4aed-8214-a6dcc4cdaf49 2026-01-12 Warnings Exact identifier application number: M021 ACT Restoring Anticavity Fluoride Cool Mint SODIUM FLUORIDE Chattem, Inc. ef63e193-5804-4b35-bae7-cad29cf4e8bc 2026-01-12 Warnings Exact identifier application number: M021 Prime Tooth Care Blueberry SODIUM FLUORIDE Prime Tooth Care LLC 86642110-4572-4b8b-88f1-8d25fe05701e 2026-01-09 Warnings Exact identifier application number: M021 Prime Tooth Care Juicy Peach SODIUM FLUORIDE Prime Tooth Care LLC 142f1610-3494-459f-a956-760e82169b87 2026-01-09 Warnings Exact identifier application number: M021 Prime Tooth Care Coconut Whip SODIUM FLUORIDE Prime Tooth Care LLC 55e95657-9415-4d9c-ac9b-d021aa14e64d 2026-01-09 Warnings Exact identifier application number: M021 Prime Tooth Care Hami Melon SODIUM FLUORIDE Prime Tooth Care LLC 0028f88d-a9fe-4cfa-a6c6-168f9689b5f6 2026-01-09 Warnings Exact identifier application number: M021 Prime Tooth Care Mango Smoothie SODIUM FLUORIDE Prime Tooth Care LLC 2f2cf851-2edc-4aaf-9083-c37bc58547de 2026-01-09 Warnings Exact identifier application number: M021 Prime Tooth Care Strawberries SODIUM FLUORIDE Prime Tooth Care LLC 7b4328bd-5d2d-40ca-8322-5e818e1babf9 2026-01-09 Warnings Exact identifier application number: M021 Prime Tooth Care Summer Watermelon SODIUM FLUORIDE Prime Tooth Care LLC b7c731a1-80e7-4571-a568-db0290a720c1 2026-01-09 Warnings Exact identifier application number: M021 Kids Prime Pediatric Dental Group Anticavity for Kids SODIUM FLUORIDE Prime Tooth Care LLC 93259174-447d-4f7a-8e55-990eb8da5151 2026-01-09 Warnings Exact identifier application number: M021 Crest 3D White Brilliance Pro Enamel Protect SODIUM FLUORIDE The Procter & Gamble Manufacturing Company f32d5708-8cb1-6499-e053-2995a90ac632 2026-01-08 Warnings Exact identifier application number: M021 Crest Pro-Health Advanced Complete Care Anticavity Fluoride SODIUM FLUORIDE The Procter & Gamble Manufacturing Company f3a644c0-da04-276d-e053-2a95a90abf27 2026-01-08 Warnings Exact identifier application number: M021 Crest Pro-Health Densify Active Repair STANNOUS FLUORIDE The Procter & Gamble Manufacturing Company f4487d78-1da8-3f33-e053-2a95a90a6d92 2026-01-08 Warnings Exact identifier application number: M021 Crest Pro-Health Densify Sensitive Care STANNOUS FLUORIDE The Procter & Gamble Manufacturing Company f435c1fe-7fbb-1b25-e053-2995a90aca11 2026-01-08 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