simethicone

Generic: simethicone

Labeler: geri-care pharmaceuticals, corp
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name simethicone
Generic Name simethicone
Labeler geri-care pharmaceuticals, corp
Dosage Form TABLET, CHEWABLE
Routes
ORAL
Active Ingredients

dimethicone 80 mg/1

Manufacturer
Geri-Care Pharmaceuticals, Corp

Identifiers & Regulatory

Product NDC 57896-791
Product ID 57896-791_43d043e1-1f90-dc96-e063-6294a90addfb
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M002
Listing Expiration 2026-12-31
Marketing Start 2004-01-01

Pharmacologic Class

Physiologic Effect
skin barrier activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 57896791
Hyphenated Format 57896-791

Supplemental Identifiers

RxCUI
314216
UPC
0357896791018 0357896791087
UNII
92RU3N3Y1O
NUI
N0000010282

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name simethicone (source: ndc)
Generic Name simethicone (source: ndc)
Application Number M002 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/1
source: ndc
Packaging
  • 100 TABLET, CHEWABLE in 1 BOTTLE (57896-791-01)
  • 80 TABLET, CHEWABLE in 1 BOTTLE (57896-791-08)
source: ndc

Packages (2)

57896-791-01 100 TABLET, CHEWABLE in 1 BOTTLE (57896-791-01) 57896-791-08 80 TABLET, CHEWABLE in 1 BOTTLE (57896-791-08)

Ingredients (1)

dimethicone (80 mg/1)

Linked Drug Pages (1)

SIMETHICONE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "43d043e1-1f90-dc96-e063-6294a90addfb", "openfda": {"nui": ["N0000010282"], "upc": ["0357896791018", "0357896791087"], "unii": ["92RU3N3Y1O"], "rxcui": ["314216"], "spl_set_id": ["be96ce05-dd74-4915-9a8f-2a1b34e2f158"], "pharm_class_pe": ["Skin Barrier Activity [PE]"], "manufacturer_name": ["Geri-Care Pharmaceuticals, Corp"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, CHEWABLE in 1 BOTTLE (57896-791-01)", "package_ndc": "57896-791-01", "marketing_start_date": "20160901"}, {"sample": false, "description": "80 TABLET, CHEWABLE in 1 BOTTLE (57896-791-08)", "package_ndc": "57896-791-08", "marketing_start_date": "20210801"}], "brand_name": "SIMETHICONE", "product_id": "57896-791_43d043e1-1f90-dc96-e063-6294a90addfb", "dosage_form": "TABLET, CHEWABLE", "pharm_class": ["Skin Barrier Activity [PE]"], "product_ndc": "57896-791", "generic_name": "Simethicone", "labeler_name": "Geri-Care Pharmaceuticals, Corp", "product_type": "HUMAN OTC DRUG", "brand_name_base": "SIMETHICONE", "active_ingredients": [{"name": "DIMETHICONE", "strength": "80 mg/1"}], "application_number": "M002", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20040101", "listing_expiration_date": "20261231"}