Gas-X

Product NDC
0067-8075
11-digit product format
000678075
Labeler code
0067
Product ID
0067-8075_3597dc18-fb8f-a1e3-e063-6394a90a04ea
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-13
Substance
DIMETHICONE, UNSPECIFIED
Active strength
500 mg/1
Pharmacologic classes
Skin Barrier Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Gas-X
Brand name suffix
Ultimate Strength Softgels
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE, UNSPECIFIED500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
92RU3N3Y1OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2477951Internal RxNorm lookup
2716712Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
24b777e5-f0b5-400d-8ca9-ae0c04b8503bAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0067-8075-20Gas-XUltimate Strength Softgels10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED101
0067-8075-20Gas-XUltimate Strength Softgels2 in 1 CARTONCAPSULE, LIQUID FILLED21

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 12 of 13 · 242 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gas Relief Ultra StrengthSIMETHICONEH E Bd83f2dcf-c8c6-4581-9406-6bad8d39d03e2024-04-09WarningsExact identifier
application number: M002
Gas-X Ultra Strength AntiGas SoftgelsSIMETHICONEHaleon US Holdings LLCee9a8404-0653-433f-90e5-7ac69bdab8df2024-04-05WarningsExact identifier
application number: M002
Gas Relief Ultra StrengthSIMETHICONECVS Pharmacybac06147-87ae-4aaa-a66b-4aeae6096d8d2024-03-13WarningsExact identifier
application number: M002
Maximum Strength Gas ReliefSIMETHICONEWALGREENS03bc9c99-2871-2604-e063-6394a90a2be52024-03-06WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEBest Choice (Valu Merchandisers Company)23eda70b-ff1e-4b4e-9f9e-034ef101cd682024-02-20WarningsExact identifier
application number: M002
Anti-Gas Ultra StrengthSIMETHICONEBest Choice (Valu Merchandisers Company)f74d9882-cc99-41b6-b851-ce89d28f33df2024-02-15WarningsExact identifier
application number: M002
Right Remedies Maximum Strength Gas Relief SoftgelSIMETHICONEStrive Pharmaceuticals Inc.032b3a89-1bc4-4f38-ba9e-0a48402153302024-02-05WarningsExact identifier
application number: M002
Maximum Strength Gas Relief SoftgelSIMETHICONECardinal Health 110, LLC. DBA Leader57043cae-a8db-4eff-835c-5995e8aea9242024-01-11WarningsExact identifier
application number: M002
GAS RELIEF EXTRA STRENGTHSIMETHICONEYYBA CORPcc79435e-6d4b-b283-e053-2995a90a8db32024-01-03WarningsExact identifier
application number: M002
Childrens Mylicon All in One Tummy Relief for KidsANTACID AND ANTIGASInfirst Healthcare Inc.0952eba8-6de2-4a77-956d-339fab4374722024-01-01WarningsExact identifier
application number: M002
Mylicon Infants Gas Relief OriginalSIMETHICONEInfirst Healthcare395be942-d883-4bcb-8811-6fe1521d5a922024-01-01WarningsExact identifier
application number: M002
Mylicon Infants Gas Relief Dye FreeSIMETHICONEInfirst Healthcare3324139a-ed22-43af-859d-e7af19a24ee92024-01-01WarningsExact identifier
application number: M002
Mylanta Gas Minis Mint FlavorSIMETHICONEInfirst Healthcare Inc.5045b945-23ee-4c25-a32c-af3cd5045c732023-12-04WarningsExact identifier
application number: M002
Mylanta Gas Minis Assorted Fruit FlavorSIMETHICONEInfirst Healthcare Inc.c6db9af2-d457-477d-baa9-470ddbba59052023-12-04WarningsExact identifier
application number: M002
Childrens Mylicon Tummy Relief for KidsANTACID AND ANTIGASInfirst Healthcare Inc.432d5b4c-a69b-45f9-b7f0-216726a3eead2023-12-01WarningsExact identifier
application number: M002
INFANTS GAS RELIEFSIMETHICONEGeri-Care Pharmaceuticals, Corp5e08709c-846a-7f13-e053-2991aa0a09a62023-11-01WarningsExact identifier
application number: M002
GAS RELIEFSIMETHICONESTRATEGIC SOURCING SERVICES LLCff1fd97c-af4f-dffb-e053-6294a90a20392023-10-26WarningsExact identifier
application number: M002
INFANT GAS RELIEFSIMETHICONEAMERISOURCEBERGEN DRUG CORPORATION7d3c3cc6-b0a2-620d-e053-2a91aa0a159b2023-07-18WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEAllegiant Healthae98861e-6a26-4e0e-a66a-b2738d3cbddd2021-09-24WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEAllegiant Health4c79535c-4372-4fd4-a91a-d93617cd581b2021-09-24WarningsExact identifier
application number: M002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2716712Gas-X 500 MG Oral CapsulePSN24b777e5-f0b5-400d-8ca9-ae0c04b8503b1
2477951simethicone 500 MG Oral CapsulePSN24b777e5-f0b5-400d-8ca9-ae0c04b8503b1
2716712simethicone 500 MG Oral Capsule [Gas-X]SBD24b777e5-f0b5-400d-8ca9-ae0c04b8503b1
2477951simethicone 500 MG Oral CapsuleSCD24b777e5-f0b5-400d-8ca9-ae0c04b8503b1
2716712Gas-X 500 MG Oral CapsuleSY24b777e5-f0b5-400d-8ca9-ae0c04b8503b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0067-8075-20000678075202 BLISTER PACK in 1 CARTON (0067-8075-20) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2025-06-13NoNoCurrent