{"id":"hydrocortisone","rwe":[],"_fda":{"id":"a43439f4-6959-43c6-95a0-44fcdb62acea","set_id":"00040bfe-001a-484e-bec0-e21e8b27f369","openfda":{"nui":["N0000175576","N0000175450"],"unii":["WI4X0X7BPJ"],"route":["TOPICAL"],"rxcui":["106258"],"spl_id":["a43439f4-6959-43c6-95a0-44fcdb62acea"],"brand_name":["anti itch"],"spl_set_id":["00040bfe-001a-484e-bec0-e21e8b27f369"],"package_ndc":["79481-0319-0","79481-0319-1"],"product_ndc":["79481-0319"],"generic_name":["HYDROCORTISONE"],"product_type":["HUMAN OTC DRUG"],"substance_name":["HYDROCORTISONE"],"pharm_class_epc":["Corticosteroid [EPC]"],"pharm_class_moa":["Corticosteroid Hormone Receptor Agonists [MoA]"],"manufacturer_name":["Meijer, Inc."],"application_number":["M017"],"is_original_packager":[true]},"purpose":["Purpose Anti-itch"],"version":"4","stop_use":["Stop use and ask a doctor if • condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor • rectal bleeding occurs"],"warnings":["Warnings For external use only Do not use • in the genital area if you have a vaginal discharge. Consult a doctor. • for the treatment of diaper rash. Consult a doctor. When using this product • avoid contact with the eyes • do not use more than directed unless told to do so by a doctor • do not put directly into the rectum by using fingers or any mechanical device or applicator Stop use and ask a doctor if • condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor • rectal bleeding occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222)."],"questions":["Questions or comments? 1-800-719-9260"],"do_not_use":["Do not use • in the genital area if you have a vaginal discharge. Consult a doctor. • for the treatment of diaper rash. Consult a doctor."],"when_using":["When using this product • avoid contact with the eyes • do not use more than directed unless told to do so by a doctor • do not put directly into the rectum by using fingers or any mechanical device or applicator"],"effective_time":"20240917","active_ingredient":["Active ingredient Hydrocortisone 1%"],"inactive_ingredient":["Inactive ingredients water, cetearyl alcohol, cetyl palmitate, glycerin, isopropyl myristate, isostearyl neopentanoate, ceteareth-20, diazolidinyl urea, sorbic acid, aloe barbadensis leaf juice, BHT sodium hydroxide"],"storage_and_handling":["Other information • store at 20-25°C (68-77°F)"],"indications_and_usage":["Uses • temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to: • eczema • psoriasis • poison ivy, oak, sumac • insect bites • detergents • jewelry • cosmetics • soaps • seborrheic dermatitis • temporarily relieves external anal and genital itching • other uses of this product should only be under the advice and supervision of a doctor"],"dosage_and_administration":["Directions • for itching of skin irritation, inflammation, and rashes: • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily • children under 2 years of age: do not use, ask a doctor • for external anal and genital itching, adults: • when practical, clean the affected area with mild soap and warm water and rinse thoroughly • gently dry by patting or blotting with toilet tissue or a soft cloth before applying • apply to affected area not more than 3 to 4 times daily • children under 12 years of age: ask a doctor"],"spl_product_data_elements":["anti itch Hydrocortisone HYDROCORTISONE HYDROCORTISONE WATER CETOSTEARYL ALCOHOL CETYL PALMITATE GLYCERIN ISOPROPYL MYRISTATE ISOSTEARYL NEOPENTANOATE POLYOXYL 20 CETOSTEARYL ETHER DIAZOLIDINYL UREA SORBIC ACID ALOE VERA LEAF BUTYLATED HYDROXYTOLUENE SODIUM HYDROXIDE"],"keep_out_of_reach_of_children":["Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222)."],"package_label_principal_display_panel":["Principal Display Panel meijer ® MAXIMUM STRENGTH Paraben Free Anti-Itch Cream HYDROCORTISONE 1% | SOOTHING ALOE Soothes Itch, Irritation & Rashes Inflammation & Redness | Insect Bites, Poison Ivy | Eczema & Psoriasis Powerful Medicine, Fast Relief COMPARE TO MAXIMUM STRENGTH CORTIZONE • 10 ® CRÈME ACTIVE INGREDIENT Fast Itch Relief NEW WT 2 OZ (56 g) 319-6e-anti-itch-cream.jpg"]},"tags":[],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"14311 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"13386 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"12026 reports"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"10480 reports"},{"date":"","signal":"ARTHRALGIA","source":"FDA 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Available since the 1950s in oral, topical, and injectable forms, it is essential for adrenal replacement therapy and widely available OTC as a 1% topical cream for dermatitis and itching.","brandName":"Cortef","companyId":"unknown","ecosystem":[],"mechanism":{"target":"Annexin A1, Corticosteroid-binding globulin, Nitric oxide synthase, inducible","novelty":"","modality":"Small molecule","drugClass":"Corticosteroid [EPC]","explanation":"","oneSentence":"","technicalDetail":""},"commercial":null,"references":[],"_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-19T23:58:03.168520+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"companyName":"Generic (originally Merck/Upjohn)","competitors":[],"dataSources":[{"url":"https://data.medicaid.gov/dataset/4j6z-xnwq","name":"CMS National Average Drug Acquisition Cost (NADAC)","fields":["pricing"],"retrievedDate":"2026-04-07"}],"genericName":"hydrocortisone","indications":{"approved":[{"name":"Acne 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