Package 82568-0017-3

Brand: simethicone infant gas relief drops

Generic: simethicone
NDC Package

Package Facts

Identity

Package NDC 82568-0017-3
Digits Only 8256800173
Product NDC 82568-0017
Product ID 82568-0017_3b14f103-c7f9-f905-e063-6294a90a0e2c
Description

1 BOTTLE in 1 PACKAGE (82568-0017-3) / 30 mL in 1 BOTTLE

Marketing

Marketing Status
Marketed Since 2025-02-20
Brand simethicone infant gas relief drops
Generic simethicone
Sample Package No

Linked Drug Pages (1)

SIMETHICONE INFANT Gas Relief Drops ndc-match (0.95)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3b14f103-c7f9-f905-e063-6294a90a0e2c", "openfda": {"nui": ["N0000010282"], "upc": ["0382568001737"], "unii": ["92RU3N3Y1O"], "rxcui": ["198857"], "spl_set_id": ["9b0fde90-35ae-498e-99cc-d120f1a87182"], "pharm_class_pe": ["Skin Barrier Activity [PE]"], "manufacturer_name": ["AARNA USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 PACKAGE (82568-0017-3)  / 30 mL in 1 BOTTLE", "package_ndc": "82568-0017-3", "marketing_start_date": "20250220"}, {"sample": false, "description": "118 mL in 1 BOTTLE (82568-0017-4)", "package_ndc": "82568-0017-4", "marketing_start_date": "20250220"}], "brand_name": "SIMETHICONE INFANT Gas Relief Drops", "product_id": "82568-0017_3b14f103-c7f9-f905-e063-6294a90a0e2c", "dosage_form": "SUSPENSION", "pharm_class": ["Skin Barrier Activity [PE]"], "product_ndc": "82568-0017", "generic_name": "Simethicone", "labeler_name": "AARNA USA Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "SIMETHICONE INFANT", "brand_name_suffix": "Gas Relief Drops", "active_ingredients": [{"name": "DIMETHICONE", "strength": "20 mg/.3mL"}], "application_number": "M002", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250220", "listing_expiration_date": "20261231"}