gas-x extra strength

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 extra strength
Generic Name simethicone
Labeler haleon us holdings llc
Dosage Form TABLET, CHEWABLE
Routes
ORAL
Active Ingredients

dimethicone, unspecified 125 mg/1

Manufacturer
Haleon US Holdings LLC

Identifiers & Regulatory

Product NDC 0067-0117
Product ID 0067-0117_b5d94cf5-198b-4797-9de7-3014bcc12202
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M002
Listing Expiration 2026-12-31
Marketing Start 2012-01-01

Pharmacologic Class

Classes
skin barrier activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00670117
Hyphenated Format 0067-0117

Supplemental Identifiers

RxCUI
210295 314221
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 extra strength (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
  • 6 BLISTER PACK in 1 CARTON (0067-0117-01) / 12 TABLET, CHEWABLE in 1 BLISTER PACK
  • 2 BLISTER PACK in 1 CARTON (0067-0117-18) / 9 TABLET, CHEWABLE in 1 BLISTER PACK
  • 3 BLISTER PACK in 1 CARTON (0067-0117-27) / 9 TABLET, CHEWABLE in 1 BLISTER PACK
  • 4 BLISTER PACK in 1 CARTON (0067-0117-48) / 12 TABLET, CHEWABLE in 1 BLISTER PACK
  • 5 BLISTER PACK in 1 CARTON (0067-0117-49) / 12 TABLET, CHEWABLE in 1 BLISTER PACK
source: ndc

Packages (5)

0067-0117-01 6 BLISTER PACK in 1 CARTON (0067-0117-01) / 12 TABLET, CHEWABLE in 1 BLISTER PACK 0067-0117-18 2 BLISTER PACK in 1 CARTON (0067-0117-18) / 9 TABLET, CHEWABLE in 1 BLISTER PACK 0067-0117-27 3 BLISTER PACK in 1 CARTON (0067-0117-27) / 9 TABLET, CHEWABLE in 1 BLISTER PACK 0067-0117-48 4 BLISTER PACK in 1 CARTON (0067-0117-48) / 12 TABLET, CHEWABLE in 1 BLISTER PACK 0067-0117-49 5 BLISTER PACK in 1 CARTON (0067-0117-49) / 12 TABLET, CHEWABLE in 1 BLISTER PACK

Ingredients (1)

dimethicone, unspecified (125 mg/1)

Linked Drug Pages (1)

Gas-X Extra Strength ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b5d94cf5-198b-4797-9de7-3014bcc12202", "openfda": {"unii": ["92RU3N3Y1O"], "rxcui": ["210295", "314221"], "spl_set_id": ["7ce312ca-542b-4bc0-97b5-f65279e1e84c"], "manufacturer_name": ["Haleon US Holdings LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 BLISTER PACK in 1 CARTON (0067-0117-01)  / 12 TABLET, CHEWABLE in 1 BLISTER PACK", "package_ndc": "0067-0117-01", "marketing_start_date": "20120101"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (0067-0117-18)  / 9 TABLET, CHEWABLE in 1 BLISTER PACK", "package_ndc": "0067-0117-18", "marketing_start_date": "20120101"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (0067-0117-27)  / 9 TABLET, CHEWABLE in 1 BLISTER PACK", "package_ndc": "0067-0117-27", "marketing_start_date": "20120101"}, {"sample": false, "description": "4 BLISTER PACK in 1 CARTON (0067-0117-48)  / 12 TABLET, CHEWABLE in 1 BLISTER PACK", "package_ndc": "0067-0117-48", "marketing_start_date": "20120101"}, {"sample": false, "description": "5 BLISTER PACK in 1 CARTON (0067-0117-49)  / 12 TABLET, CHEWABLE in 1 BLISTER PACK", "package_ndc": "0067-0117-49", "marketing_start_date": "20120101"}], "brand_name": "Gas-X Extra Strength", "product_id": "0067-0117_b5d94cf5-198b-4797-9de7-3014bcc12202", "dosage_form": "TABLET, CHEWABLE", "pharm_class": ["Skin Barrier Activity [PE]"], "product_ndc": "0067-0117", "generic_name": "Simethicone", "labeler_name": "Haleon US Holdings LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Gas-X", "brand_name_suffix": "Extra Strength", "active_ingredients": [{"name": "DIMETHICONE, UNSPECIFIED", "strength": "125 mg/1"}], "application_number": "M002", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20120101", "listing_expiration_date": "20261231"}