{ "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": "2026-06-02", "results": { "skip": 0, "limit": 1, "total": 5 } }, "results": [ { "spl_product_data_elements": [ "Diphenhydramine HCl Oral Solution Diphenhydramine HCl Oral DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE CITRIC ACID MONOHYDRATE FD&C RED NO. 40 METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM CITRATE, UNSPECIFIED FORM SUCRALOSE Diphenhydramine HCl Oral Solution Diphenhydramine HCl Oral DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE CITRIC ACID MONOHYDRATE FD&C RED NO. 40 METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN WATER SODIUM CITRATE, UNSPECIFIED FORM SUCRALOSE" ], "spl_unclassified_section": [ "Drug Facts", "Other information • each 5 mL contains sodium: 3 mg • store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] • do not use if lid is torn or broken", "Distributed by: MAJOR® PHARMACEUTICALS Indianapolis, IN 46268 (800) 616-2471" ], "active_ingredient": [ "Active ingredient per 5 mL (1 Unit Dose) Diphenhydramine HCl 12.5 mg", "Active ingredient per 10 mL (1 Unit Dose) Diphenhydramine HCl 25 mg" ], "purpose": [ "Purpose Antihistamine" ], "indications_and_usage": [ "Uses Temporarily relieves these symptoms due to hay fever or other respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itching of the nose or throat" ], "warnings": [ "Warnings Do not use • to make a child sleepy • with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if the child has • a breathing problem such as chronic bronchitis • glaucoma Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers When using this product • marked drowsiness may occur • sedatives and tranquilizers may increase drowsiness • excitability may occur, especially in children Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)" ], "do_not_use": [ "Do not use • to make a child sleepy • with any other product containing diphenhydramine, even one used on skin" ], "ask_doctor": [ "Ask a doctor before use if the child has • a breathing problem such as chronic bronchitis • glaucoma" ], "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers" ], "when_using": [ "When using this product • marked drowsiness may occur • sedatives and tranquilizers may increase drowsiness • excitability may occur, especially in children" ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)" ], "dosage_and_administration": [ "Directions For the 5 mL Unit-Dose: • take every 4 to 6 hours, or as directed by a physician • do not take more than 6 doses in 24 hours age dose Children under 2 years of age Do not use Children 2 to under 6 years of age Do not use unless directed by a doctor Children 6 to under 12 years of age 5 mL (12.5 mg) to 10 mL (25 mg)", "Directions For the 10 mL Unit-Dose: • take every 4 to 6 hours, or as directed by a physician • do not take more than 6 doses in 24 hours age dose Children under 6 years of age Do not use Children 6 to under 12 years of age 10 mL (25 mg) Adults and children 12 years of age and over 10 mL (25 mg) to 20 mL (50 mg)" ], "dosage_and_administration_table": [ "
agedose
Children under 2 years of ageDo not use
Children 2 to under 6 years of ageDo not use unless directed by a doctor
Children 6 to under 12 years of age5 mL (12.5 mg) to 10 mL (25 mg)
", "
agedose
Children under 6 years of age Do not use
Children 6 to under 12 years of age 10 mL (25 mg)
Adults and children 12 years of age and over 10 mL (25 mg) to 20 mL (50 mg)
" ], "inactive_ingredient": [ "Inactive ingredients: citric acid, flavor, FD&C red#40, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, and sucralose" ], "questions": [ "Questions or comments? (855) 879-4368" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL MAJOR® NDC 0904-7323-41 Each 5 mL Contains: Diphenhydramine HCL Oral Solution 12.5 mg/5 mL Antihistamine Delivers 5 mL • See insert For Institutional Use Only Cherry Flavor MAJOR® PHARMACEUTICALS Indianapolis, IN 46268 Sugar Free • Alcohol Free 5mLPrincipalDisplay", "PRINCIPAL DISPLAY PANEL MAJOR® NDC 0904-7324-66 Each 10 mL Contains: Diphenhydramine HCL Oral Solution 25 mg/10 mL Antihistamine Delivers 10 mL • See insert For Institutional Use Only Cherry Flavor MAJOR® PHARMACEUTICALS Indianapolis, IN 46268 Sugar Free • Alcohol Free 10mLPrincipalDisplay" ], "set_id": "0f9015c9-a95a-5703-e063-6394a90a6ad2", "id": "425e484b-f7c7-4776-8d72-9a5bfb4f6dc5", "effective_time": "20250904", "version": "3", "openfda": { "application_number": [ "M012" ], "brand_name": [ "Diphenhydramine HCl Oral Solution" ], "generic_name": [ "DIPHENHYDRAMINE HCL ORAL" ], "manufacturer_name": [ "Major Pharmaceuticals" ], "product_ndc": [ "0904-7323", "0904-7324" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "DIPHENHYDRAMINE HYDROCHLORIDE" ], "rxcui": [ "1049906" ], "spl_id": [ "425e484b-f7c7-4776-8d72-9a5bfb4f6dc5" ], "spl_set_id": [ "0f9015c9-a95a-5703-e063-6394a90a6ad2" ], "package_ndc": [ "0904-7323-41", "0904-7323-70", "0904-7324-66", "0904-7324-72" ], "is_original_packager": [ true ], "upc": [ "0309047323418", "0309047324668" ], "unii": [ "TC2D6JAD40" ] } } ] }