simethicone

Generic: simethicone

Labeler: softgel healthcare pvt ltd
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name simethicone
Generic Name simethicone
Labeler softgel healthcare pvt ltd
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

dimethicone 125 mg/1

Manufacturer
Softgel Healthcare Pvt Ltd

Identifiers & Regulatory

Product NDC 35916-1938
Product ID 35916-1938_47dec041-1f67-880a-e063-6394a90a2164
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M002
Listing Expiration 2027-12-31
Marketing Start 2025-10-28

Pharmacologic Class

Physiologic Effect
skin barrier activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 359161938
Hyphenated Format 35916-1938

Supplemental Identifiers

RxCUI
198852
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
  • 125 mg/1
source: ndc
Packaging
  • 1000 CAPSULE, LIQUID FILLED in 1 BAG (35916-1938-1)
  • 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (35916-1938-2)
  • 2 BAG in 1 BOX (35916-1938-3) / 1500 CAPSULE, LIQUID FILLED in 1 BAG
source: ndc

Packages (3)

35916-1938-1 1000 CAPSULE, LIQUID FILLED in 1 BAG (35916-1938-1) 35916-1938-2 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (35916-1938-2) 35916-1938-3 2 BAG in 1 BOX (35916-1938-3) / 1500 CAPSULE, LIQUID FILLED in 1 BAG

Ingredients (1)

dimethicone (125 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": "47dec041-1f67-880a-e063-6394a90a2164", "openfda": {"nui": ["N0000010282"], "unii": ["92RU3N3Y1O"], "rxcui": ["198852"], "spl_set_id": ["32018302-7ce5-1f15-e063-6394a90ad378"], "pharm_class_pe": ["Skin Barrier Activity [PE]"], "manufacturer_name": ["Softgel Healthcare Pvt Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 CAPSULE, LIQUID FILLED in 1 BAG (35916-1938-1)", "package_ndc": "35916-1938-1", "marketing_start_date": "20251028"}, {"sample": false, "description": "30 CAPSULE, LIQUID FILLED in 1 BOTTLE (35916-1938-2)", "package_ndc": "35916-1938-2", "marketing_start_date": "20251028"}, {"sample": false, "description": "2 BAG in 1 BOX (35916-1938-3)  / 1500 CAPSULE, LIQUID FILLED in 1 BAG", "package_ndc": "35916-1938-3", "marketing_start_date": "20260116"}], "brand_name": "Simethicone", "product_id": "35916-1938_47dec041-1f67-880a-e063-6394a90a2164", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Skin Barrier Activity [PE]"], "product_ndc": "35916-1938", "generic_name": "Simethicone", "labeler_name": "Softgel Healthcare Pvt Ltd", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Simethicone", "active_ingredients": [{"name": "DIMETHICONE", "strength": "125 mg/1"}], "application_number": "M002", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20251028", "listing_expiration_date": "20271231"}