Package 82568-0016-8

Brand: diphenhydramine hcl 12.5 mg per 5 ml

Generic: diphenhydramine hcl 12.5 mg per 5 ml
NDC Package

Package Facts

Identity

Package NDC 82568-0016-8
Digits Only 8256800168
Product NDC 82568-0016
Product ID 82568-0016_3404aa22-166f-5501-e063-6394a90a1e7a
Description

236 mL in 1 BOTTLE (82568-0016-8)

Marketing

Marketing Status
Marketed Since 2025-04-14
Brand diphenhydramine hcl 12.5 mg per 5 ml
Generic diphenhydramine hcl 12.5 mg per 5 ml
Sample Package No

Linked Drug Pages (1)

DIPHENHYDRAMINE HCL 12.5 MG PER 5 ML ndc-match (0.95)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3404aa22-166f-5501-e063-6394a90a1e7a", "openfda": {"nui": ["N0000000190", "N0000175587"], "unii": ["8GTS82S83M"], "rxcui": ["1049906"], "spl_set_id": ["32c26835-f54e-d7e5-e063-6294a90ae1c0"], "pharm_class_epc": ["Histamine-1 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H1 Receptor Antagonists [MoA]"], "manufacturer_name": ["AARNA USA INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "118 mL in 1 BOTTLE (82568-0016-4)", "package_ndc": "82568-0016-4", "marketing_start_date": "20250414"}, {"sample": false, "description": "473 mL in 1 BOTTLE (82568-0016-6)", "package_ndc": "82568-0016-6", "marketing_start_date": "20250414"}, {"sample": false, "description": "236 mL in 1 BOTTLE (82568-0016-8)", "package_ndc": "82568-0016-8", "marketing_start_date": "20250414"}], "brand_name": "DIPHENHYDRAMINE HCL 12.5 MG PER 5 ML", "product_id": "82568-0016_3404aa22-166f-5501-e063-6394a90a1e7a", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "82568-0016", "generic_name": "DIPHENHYDRAMINE HCL 12.5 MG PER 5 ML", "labeler_name": "AARNA USA INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "DIPHENHYDRAMINE HCL 12.5 MG PER 5 ML", "active_ingredients": [{"name": "DIPHENHYDRAMINE", "strength": "12.5 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250414", "listing_expiration_date": "20261231"}