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United States · US · US:10237-677_1b5ce44b-79ef-4d10-b4a0-2b8c3dd67edd
Orajel Complete Protection
In shortageUNIISPLATC C03CB
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerChurch & Dwight Co., Inc.
CountryUS (United States)
ATC codeC03CB
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1110237677122 TUBE in 1 CARTON (10237-677-12) / 170 g in 1 TUBE
- ndc1110237677431 TUBE in 1 CARTON (10237-677-43) / 121.9 g in 1 TUBE
Annotations
UNII (FDA Substance ID)
RU45X2JN0Z
POTASSIUM NITRATE
RxCUI 34316
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Potassium Chloride Tablet, Extended Release
Raw payload (JSON)
{
"unii": {
"unii": "RU45X2JN0Z",
"rxcui": "34316",
"inchikey": "FGIUAXJPYTZDNR-UHFFFAOYSA-N",
"display_name": "POTASSIUM NITRATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"ce40829e-941f-2548-e053-2995a90a1e0e": {
"match": "brand_token",
"title": "ORAJEL COLD SORE TOUCH FREE - SINGLE DOSE (BENZALKONIUM CHLORIDE, BENZOCAINE) LIQUID [CHURCH & DWIGHT CO., INC.]",
"spl_version": "6",
"published_date": "2026-05-15"
}
},
"productid": "10237-677_1b5ce44b-79ef-4d10-b4a0-2b8c3dd67edd",
"productndc": "10237-677",
"dosage_form": "PASTE",
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "POTASSIUM NITRATE; SODIUM FLUORIDE",
"shortage_reason": "Potassium Chloride Tablet, Extended Release",
"shortage_status": "current",
"proprietary_name": "Orajel Complete Protection",
"active_ingred_unit": "g/100g; g/100g",
"application_number": "M021",
"marketing_category": "OTC MONOGRAPH DRUG",
"nonproprietary_name": "Sodium Fluoride",
"start_marketing_date": "20240101",
"active_numerator_strength": "5; .243"
}Related drugs
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