{
"meta": {
"disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
"terms": "https://open.fda.gov/terms/",
"license": "https://open.fda.gov/license/",
"last_updated": "2026-10-28",
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{
"spl_product_data_elements": [
"Orajel Sensitivity Relief Sodium Fluoride and Potassium Nitrate SODIUM FLUORIDE FLUORIDE ION POTASSIUM NITRATE NITRATE ION WATER SORBITOL HYDRATED SILICA POLYETHYLENE GLYCOL 400 SODIUM LAURYL SULFATE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED TITANIUM DIOXIDE SACCHARIN SODIUM"
],
"spl_unclassified_section": [
"Drug Facts"
],
"active_ingredient": [
"Active ingredients Purpose Sodium Fluoride 0.24% (0.17% w/v Fluoride Ion) Anticavity Potassium Nitrate 5.0% Tooth Desensitizer"
],
"active_ingredient_table": [
"
"
],
"indications_and_usage": [
"Use Aids in the prevention of dental decay Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact"
],
"warnings": [
"Warnings Do not use if irritation occurs and persists. When using this product do not use longer than 4 weeks unless recommended by a dentist or physician. Stop use and ask a dentist if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away."
],
"do_not_use": [
"Do not use if irritation occurs and persists."
],
"when_using": [
"When using this product do not use longer than 4 weeks unless recommended by a dentist or physician."
],
"stop_use": [
"Stop use and ask a dentist if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist."
],
"keep_out_of_reach_of_children": [
"Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away."
],
"dosage_and_administration": [
"Directions Do not swallow Supervise children as necessary until capable of using without supervision Rinse away toothpaste residue thoroughly after brushing Adults and children 12 years of age and older: Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Children under 12 years of age: Consult a dentist or doctor."
],
"inactive_ingredient": [
"Inactive ingredients Sorbitol, water, hydrated silica, PEG-8, sodium lauryl sulfate, flavor, cellulose gum, titanium dioxide, sodium saccharin"
],
"questions": [
"Questions or comments? Call 1-800-786-5135 Mon.–Fri. 9am–5pm ET or visit www.orajel.com"
],
"package_label_principal_display_panel": [
"PRINCIPAL DISPLAY PANEL - 121.9 g Tube Carton NEW #1 ORAL PAIN RELIEF BRAND Orajel ™ Anticavity Toothpaste For Sensitive Teeth SOOTHING MINT SENSITIVITY RELIEF 24/7 SENSITIVITY RELIEF TOOTHPASTE* Maxiumum sensitivity relief without a prescription Sensitivity protection from hot and cold NET WT 4.3 OZ (121.9 g) Principal Display Panel - 121.9 g Tube Carton"
],
"set_id": "7b9d9e7d-3844-4d18-ab03-bd0e9dcfccdb",
"id": "88d71cb7-8abf-407d-a74c-f5537497759a",
"effective_time": "20231219",
"version": "2",
"openfda": {
"application_number": [
"M021"
],
"brand_name": [
"Orajel Sensitivity Relief"
],
"generic_name": [
"SODIUM FLUORIDE AND POTASSIUM NITRATE"
],
"manufacturer_name": [
"Church & Dwight Co., Inc."
],
"product_ndc": [
"10237-678"
],
"product_type": [
"HUMAN OTC DRUG"
],
"route": [
"ORAL"
],
"substance_name": [
"SODIUM FLUORIDE",
"POTASSIUM NITRATE"
],
"spl_id": [
"88d71cb7-8abf-407d-a74c-f5537497759a"
],
"spl_set_id": [
"7b9d9e7d-3844-4d18-ab03-bd0e9dcfccdb"
],
"package_ndc": [
"10237-678-43",
"10237-678-12"
],
"is_original_packager": [
true
],
"unii": [
"8ZYQ1474W7",
"RU45X2JN0Z"
]
}
}
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}