{"active_ingredient":["Active ingredients Benzocaine 20% Menthol 0.1%"],"do_not_use":["Do not use • more than directed • for more than 7 days unless directed by a dentist or doctor • for teething • in children under 2 years of age"],"dosage_and_administration":["Directions • remove safety seal from bottle cap adults and children 2 years of age and over Apply product with applicator brush to the affected area. Use up to 4 times daily or as directed by a dentist or doctor. children between 2 and 12 years of age should be supervised in the use of this product children under 2 years of age do not use"],"dosage_and_administration_table":["<table border=\"1\"><tbody><tr><td>adults and children 2 years of age and over</td><td><paragraph>Apply product with applicator brush to the affected area. Use up to 4 times daily or as directed by a dentist or doctor.</paragraph></td></tr><tr><td>children between 2 and 12 years of age</td><td>should be supervised in the use of this product</td></tr><tr><td>children under 2 years of age</td><td>do not use</td></tr></tbody></table>"],"effective_time":"20260601","id":"557be35d-65ca-291a-e063-6294a90aac6e","inactive_ingredient":["Inactive ingredients alcohol (54.5% by volume), flavor, PEG-8, red 40, sodium saccarin, water, yellow 5"],"indications_and_usage":["Uses Uses for the temporary relief of pain due to • canker sores • minor injury of the mouth and gums • minor irritation of the mouth and gums caused by dentures or orthodontic appliances"],"keep_out_of_reach_of_children":["Keep out of reach of children. If more than is used for pain relief is accidentally swallowed, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["M022"],"brand_name":["Orajel Medicated for Toothache and Gum, Liquid"],"generic_name":["BENZOCAINE AND MENTHOL"],"is_original_packager":[true],"manufacturer_name":["Church & Dwight Co., Inc."],"nui":["N0000185508","N0000175629","N0000184306","M0000728"],"package_ndc":["10237-796-45"],"pharm_class_cs":["Allergens [CS]"],"pharm_class_epc":["Standardized Chemical Allergen [EPC]"],"pharm_class_pe":["Increased Histamine Release [PE]","Cell-mediated Immunity [PE]"],"product_ndc":["10237-796"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["2110600"],"spl_id":["557be35d-65ca-291a-e063-6294a90aac6e"],"spl_set_id":["ac3d605d-241d-1a6f-e053-2a95a90ae391"],"substance_name":["BENZOCAINE","MENTHOL, UNSPECIFIED FORM"],"unii":["U3RSY48JW5","L7T10EIP3A"]},"other_safety_information":["Other information • do not use if safety seal on bottle cap is broken or missing prior to opening"],"package_label_principal_display_panel":["#1 ORAL PAIN RELIEF BRAND FOR TOOTHACHE AND MOUTH SORES Orajel™ 2x MEDICATED TOOTHACHE & MOUTH SORES IMMEDIATE PAIN RELIEF Relieves Throbbing Pain Delivers Targeted Pain Relief Provides Long-Lasting Pain Relief* Soothes Irritated Gums ORAL-PAIN RELIEVER NEW! APPLICATOR BRUSH FAST-ACTING LIQUID *Up to 2 Hours 0.45 FL OZ (13.3 mL) Orajel 2x Medicated Toothache Carton 2026"],"purpose":["Purpose Oral pain reliever"],"questions":["Questions or comments? Call us at 800 952 5080 M-F 9am-5pm ET or visit our website at www orajel.com"],"set_id":"ac3d605d-241d-1a6f-e053-2a95a90ae391","spl_product_data_elements":["Orajel Medicated for Toothache and Gum, Liquid Benzocaine and Menthol FD&C YELLOW NO. 5 ALCOHOL SACCHARIN SODIUM FD&C RED NO. 40 WATER BENZOCAINE BENZOCAINE MENTHOL, UNSPECIFIED FORM MENTHOL, UNSPECIFIED FORM POLYETHYLENE GLYCOL, UNSPECIFIED"],"spl_unclassified_section":["Drug Facts Orajel 2x Medicated Toothache and Mouth Sores"],"stop_use":["Stop use and ask a doctor if • swelling, rash or fever develops • irritation, pain or redness persists or worsens • sore mouth symptoms do not improve in 7 days"],"version":"6","warnings":["Warnings Methemoglobinemia warning : Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in the blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops: • pale, gray or blue colored skin (cyanosis) • headache • rapid heart rate • shortness or breath • dizziness or lightheadedness • fatigue or lack of energy Allergy Alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other \"caine\" anesthetics Flammable : keep away from fire or flame. Avoid smoking during application. Do not use • more than directed • for more than 7 days unless directed by a dentist or doctor • for teething • in children under 2 years of age Stop use and ask a doctor if • swelling, rash or fever develops • irritation, pain or redness persists or worsens • sore mouth symptoms do not improve in 7 days Keep out of reach of children. If more than is used for pain relief is accidentally swallowed, get medical help or contact a Poison Control Center right away."]}