gas-x ultimate strength softgels

Generic: simethicone

Labeler: haleon us holdings llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name gas-x ultimate strength softgels
Generic Name simethicone
Labeler haleon us holdings llc
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

dimethicone, unspecified 500 mg/1

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0067-8075
Product ID 0067-8075_3597dc18-fb8f-a1e3-e063-6394a90a04ea
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M002
Listing Expiration 2026-12-31
Marketing Start 2025-06-13

Pharmacologic Class

Classes
skin barrier activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00678075
Hyphenated Format 0067-8075

Supplemental Identifiers

RxCUI
2477951 2716712
UNII
92RU3N3Y1O

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-x ultimate strength softgels (source: ndc)
Generic Name simethicone (source: ndc)
Application Number M002 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (0067-8075-20) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
source: ndc

Packages (1)

Ingredients (1)

dimethicone, unspecified (500 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "3597dc18-fb8f-a1e3-e063-6394a90a04ea", "openfda": {"unii": ["92RU3N3Y1O"], "rxcui": ["2477951", "2716712"], "spl_set_id": ["24b777e5-f0b5-400d-8ca9-ae0c04b8503b"], "manufacturer_name": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (0067-8075-20)  / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "0067-8075-20", "marketing_start_date": "20250613"}], "brand_name": "Gas-X Ultimate Strength Softgels", "product_id": "0067-8075_3597dc18-fb8f-a1e3-e063-6394a90a04ea", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Skin Barrier Activity [PE]"], "product_ndc": "0067-8075", "generic_name": "Simethicone", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Gas-X", "brand_name_suffix": "Ultimate Strength Softgels", "active_ingredients": [{"name": "DIMETHICONE, UNSPECIFIED", "strength": "500 mg/1"}], "application_number": "M002", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250613", "listing_expiration_date": "20261231"}