{ "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", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "Giltuss Bucalsep Benzocaine, Menthol, Zinc chloride CETYLPYRIDINIUM CHLORIDE SPEARMINT GLYCERIN METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER SUCRALOSE BENZOCAINE BENZOCAINE MENTHOL MENTHOL ZINC CHLORIDE ZINC CATION Light yellow" ], "spl_unclassified_section": [ "Drug Facts", "MANUFACTURED FOR: GIL PHARMACEUTICAL CORP. PONCE, PUERTO RICO 00717-1565 giltuss.com" ], "active_ingredient": [ "Active ingredients (in each 30 mL) Benzocaine, 6.5% (1950 mg) Zinc Chloride, 0.12% (36 mg) Menthol, 0.1% (30 mg)" ], "purpose": [ "Purposes Anesthetic Astringent Anesthetic" ], "warnings": [ "Warnings Do not use IN OR NEAR THE EYES. In the event of accidental contact with the eyes, flush immediately and continuously for 10 minutes. Seek immediate medical attention if pain or irritation persists this product for more than 7 days unless directed by a doctor or a dentist Ask a doctor or pharmacist before use if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other \"caine\" anesthetics When using this product, do not exceed recommended dosage Stop use and ask a doctor or dentist if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, swelling, rash, nausea, or vomiting symptoms do not improve in 7 days irritation, pain or redness persists or increases, or a rash appears on the skin If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately." ], "do_not_use": [ "Do not use IN OR NEAR THE EYES. In the event of accidental contact with the eyes, flush immediately and continuously for 10 minutes. Seek immediate medical attention if pain or irritation persists this product for more than 7 days unless directed by a doctor or a dentist" ], "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other \"caine\" anesthetics" ], "when_using": [ "When using this product, do not exceed recommended dosage" ], "stop_use": [ "Stop use and ask a doctor or dentist if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, swelling, rash, nausea, or vomiting symptoms do not improve in 7 days irritation, pain or redness persists or increases, or a rash appears on the skin" ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, ask a health professional before use." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately." ], "dosage_and_administration": [ "Directions Adults and children 2 years of age and older: Spray Giltuss Bucalsep several times to affected areas in the mouth or lips or as directed by a doctor or dentist use as a gargle or mouthwash gargle, swish around in the mouth, or allow to remain in place at least 1 minute and then spit out use up to 4 times daily or as directed by a doctor or dentist Children under 12 years of age: should be supervised in the use of this product Children under 2 years of age: consult a dentist or doctor" ], "storage_and_handling": [ "Other information Tamper evident: Do not use if safety seal is broken or missing Store at room temperature" ], "questions": [ "Questions or Comments? Call 1-800-848-9114 , Mon. - Fri. 9:00 a.m. thru 5:00 p.m. EST. Call your doctor for medical advice in the event of side effects." ], "inactive_ingredient": [ "Inactive ingredients: Cetylpyridinium chloride, Spearmint Flavor, Glycerin, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, Sucralose" ], "indications_and_usage": [ "Uses for the temporary relief of occasional minor irritations, pain, sore mouth, sore throat, pain associated with canker sores, pain due to minor irritation or injury of the mouth and gums, pain due to dental procedures, pain due to minor irritations caused by dentures or orthodontic appliances, sore gums" ], "package_label_principal_display_panel": [ "MAXIMUM STRENGTH Oral Spray Giltuss BUCALSEP® SORE THROAT AND ORAL INFECTIONS ALCOHOL FREE. SUGAR FREE. DYE FREE RELIEVES SORE THROAT THROAT INFECTION CANKER SORES OTHER ORAL PAINS AND INJURIES SPEARMINT FLAVOR 1FL OZ (30 mL) 58552-135 Bucalsep" ], "set_id": "85053391-8d71-ab4f-e053-2991aa0a7e08", "id": "40b86bd0-283d-5043-e063-6394a90ada9c", "effective_time": "20251009", "version": "6", "openfda": { "application_number": [ "M022" ], "brand_name": [ "Giltuss Bucalsep" ], "generic_name": [ "BENZOCAINE, MENTHOL, ZINC CHLORIDE" ], "manufacturer_name": [ "Gil Pharmaceutical Corp" ], "product_ndc": [ "58552-135" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL", "TOPICAL" ], "substance_name": [ "BENZOCAINE", "MENTHOL", "ZINC CHLORIDE" ], "rxcui": [ "2170427" ], "spl_id": [ "40b86bd0-283d-5043-e063-6394a90ada9c" ], "spl_set_id": [ "85053391-8d71-ab4f-e053-2991aa0a7e08" ], "package_ndc": [ "58552-135-01" ], "is_original_packager": [ true ], "nui": [ "N0000185508", "N0000175629", "N0000184306", "M0000728" ], "pharm_class_epc": [ "Standardized Chemical Allergen [EPC]" ], "pharm_class_pe": [ "Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]" ], "pharm_class_cs": [ "Allergens [CS]" ], "unii": [ "U3RSY48JW5", "L7T10EIP3A", "86Q357L16B" ] } } ] }