Home NDC 10237-677 Orajel Complete Protection
Product NDC 10237-677
11-digit product format 102370677
Labeler code 10237
Product ID 10237-677_1b5ce44b-79ef-4d10-b4a0-2b8c3dd67edd
Type HUMAN OTC DRUG
Nonproprietary name Sodium Fluoride
Dosage form PASTE
Route ORAL
Labeler Church & Dwight Co., Inc.
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-01-01
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 Complete Protection
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 10237-677-12 Orajel Complete Protection 170 g in 1 TUBE PASTE 170 3 10237-677-12 Orajel Complete Protection 2 in 1 CARTON PASTE 2 3 10237-677-43 Orajel Complete Protection 121.9 g in 1 TUBE PASTE 121.9 3 10237-677-43 Orajel Complete Protection 1 in 1 CARTON PASTE 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10237-677 ORAJEL COMPLETE PROTECTION (SODIUM FLUORIDE) PASTE [CHURCH & DWIGHT CO., INC.] 3 Current NDC, 4 package rows 20240404_daebd16f-d278-446d-8b7a-33add5a74fdd.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 40 of 50 · 995 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 10237-677-12 10237067712 2 TUBE in 1 CARTON (10237-677-12) / 170 g in 1 TUBE 2 tube 2024-05-01 No No Current 10237-677-43 10237067743 1 TUBE in 1 CARTON (10237-677-43) / 121.9 g in 1 TUBE 1 tube 2024-01-01 No No Current