Home NDC 10237-785 Orajel KidsToothpaste
Product NDC 10237-785
11-digit product format 102370785
Labeler code 10237
Product ID 10237-785_557a7351-42a8-5c23-e063-6294a90a5cf2
Type HUMAN OTC DRUG
Nonproprietary name Sodium fluoride
Dosage form PASTE, DENTIFRICE
Route DENTAL
Labeler Church & Dwight Co., Inc.
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-11-01
Substance SODIUM FLUORIDE
Active strength 1.5 mg/g
NDC exclude flag No
Listing certified through 2027-12-31
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 KidsToothpaste
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE 1.5 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8ZYQ1474W7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 416783 Internal RxNorm 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 10237-785-42 Orajel KidsToothpaste 119 g in 1 TUBE PASTE, DENTIFRICE 119 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10237-785 ORAJEL KIDSTOOTHPASTE (SODIUM FLUORIDE) PASTE, DENTIFRICE [CHURCH & DWIGHT CO., INC.] 5 Current NDC, Legacy NDC, 1 package rows 20241129_99d62125-c2c5-5926-e053-2995a90aaa29.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 50 · 995 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 10237-785-42 10237078542 119 g in 1 TUBE (10237-785-42) 119 g 2020-01-15 0000-00-00 No No Current