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
POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength
5; .243 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
RU45X2JN0ZPOTASSIUM NITRATE7757-79-1POTASSIUM NITRATE
8ZYQ1474W7SODIUM FLUORIDE7681-49-4SODIUM FLUORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10237-677-12102370677122 TUBE in 1 CARTON (10237-677-12) / 170 g in 1 TUBE2 tube2024-05-01NoNoHistorical
10237-677-43102370677431 TUBE in 1 CARTON (10237-677-43) / 121.9 g in 1 TUBE1 tube2024-01-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Orajel ™ Complete Protection ToothpasteChurch & Dwight Co., Inc.2023-12-19HUMAN OTC DRUG LABEL3