gas relief simethicone 125mg softgel

Generic: simethicone

Labeler: nuvicare llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name gas relief simethicone 125mg softgel
Generic Name simethicone
Labeler nuvicare llc
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

dimethicone 125 mg/1

Manufacturer
NUVICARE LLC

Identifiers & Regulatory

Product NDC 84324-014
Product ID 84324-014_5b5f1c15-7b17-42be-b068-804e60596153
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M002
Listing Expiration 2026-12-31
Marketing Start 2024-07-18

Pharmacologic Class

Physiologic Effect
skin barrier activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 84324014
Hyphenated Format 84324-014

Supplemental Identifiers

RxCUI
198852
UPC
0384324000121
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 gas relief simethicone 125mg softgel (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
  • 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (84324-014-01)
source: ndc

Packages (1)

84324-014-01 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (84324-014-01)

Ingredients (1)

dimethicone (125 mg/1)

Linked Drug Pages (1)

Gas Relief Simethicone 125mg Softgel ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5b5f1c15-7b17-42be-b068-804e60596153", "openfda": {"nui": ["N0000010282"], "upc": ["0384324000121"], "unii": ["92RU3N3Y1O"], "rxcui": ["198852"], "spl_set_id": ["b774c8e6-e68e-4a13-834d-7eba34c5c3e0"], "pharm_class_pe": ["Skin Barrier Activity [PE]"], "manufacturer_name": ["NUVICARE LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, LIQUID FILLED in 1 BOTTLE (84324-014-01)", "package_ndc": "84324-014-01", "marketing_start_date": "20240718"}], "brand_name": "Gas Relief Simethicone 125mg Softgel", "product_id": "84324-014_5b5f1c15-7b17-42be-b068-804e60596153", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Skin Barrier Activity [PE]"], "product_ndc": "84324-014", "generic_name": "Simethicone", "labeler_name": "NUVICARE LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Gas Relief Simethicone 125mg Softgel", "active_ingredients": [{"name": "DIMETHICONE", "strength": "125 mg/1"}], "application_number": "M002", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240718", "listing_expiration_date": "20261231"}