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 5 of 13 · 242 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ULTRA STRENGTH Gas Relief SoftgelsSIMETHICONETopco Associates LLC42c449cc-a450-1796-e063-6294a90a762a2025-12-13WarningsExact identifier
application number: M002
EXTRA STRENGTH GAS RELIEFSIMETHICONEGeri-Care Pharmaceuticals, Corpb6701200-eb58-30f1-e053-2a95a90a032e2025-12-10WarningsExact identifier
application number: M002
Motion Sickness ReliefMECLIZINE HCLShield Pharmaceuticals Corp9b5ad2ca-a47b-434a-97b5-8f729740d4ee2025-12-09WarningsExact identifier
application number: M002
CVS Health Maximum StrengthANTACID AND ANTIGASCVS Pharmacy,Inc.0a13ac81-0c63-48c1-bbb0-f6e67f97b8962025-12-04WarningsExact identifier
application number: M002
Quality Choice Infants Dye Free Gas ReliefSIMETHICONECHAIN DRUG MARKETING ASSOCIATION6b8a1eaa-6f8c-4ab6-81e0-9d64f6f1b5e42025-12-04WarningsExact identifier
application number: M002
AntiflatulentSIMETHICONEMajor Pharmaceuticalsd321114e-09ac-4252-a6e6-3dbc3a451ee62025-12-03WarningsExact identifier
application number: M002
QC Gas Relief Mint FlavorSIMETHICONEQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)26b83259-744b-4711-a32f-9f8fe5d0555b2025-12-03WarningsExact identifier
application number: M002
Walgreens Infants Dye Free Gas ReliefSIMETHICONEWALGREEN CO.05d2a37f-f47d-40e6-a799-120d846bf5d62025-12-02WarningsExact identifier
application number: M002
Quality Choice Gas Relief Extra Strength SoftgelsSIMETHICONEChain Drug Marketing Association849802d6-698d-479b-9036-781317a59ade2025-12-02WarningsExact identifier
application number: M002
Walgreens Extra StrengthSIMETHICONEWALGREENS CO.dbd2ed5b-14b1-4bdf-bd0a-84579ca3d8152025-11-25WarningsExact identifier
application number: M002
Extra Strength Gas ReliefSIMETHICONE ANTIGASWALGREENS CO.bf6f5463-a88c-4854-be4d-319582e564792025-11-25WarningsExact identifier
application number: M002
Gas Relief Extra StrengthSIMETHICONEBJWC (Berkley & Jensen / BJ's)0198f55b-735d-4354-83aa-acdc644af2c92025-11-19WarningsExact identifier
application number: M002
Gas Relief Extra StrengthSIMETHICONEMajor Pharmaceuticals4f445be1-220d-4660-abb2-c24cd33e7ca72025-11-19WarningsExact identifier
application number: M002
Gas Relief Extra StrengthSIMETHICONECardinal Health (Leader) 700004ce6d62c-9321-4b11-94ea-c51a94f351812025-11-19WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEFamily Dollar (FAMILY WELLNESS)04736bb0-58fa-4d6d-ac0a-761c0429f85e2025-11-19WarningsExact identifier
application number: M002
Gas Relief Extra StrengthSIMETHICONEUnited Natural Foods, Inc. dba UNFIbdd7147b-dcb4-4aa0-a3a1-ec9ceaeec7872025-11-19WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEStrategic Sourcing Services LLCfa85df3f-243d-470b-ad28-82512e05fbbe2025-11-19WarningsExact identifier
application number: M002
Gas Relief Extra StrengthSIMETHICONEP & L Development, LLC4120832d-6c98-43f6-bdac-c88376c88c302025-11-17WarningsExact identifier
application number: M002
SIMETHICONESIMETHICONEGeri-Care Pharmaceuticals, Corpbe96ce05-dd74-4915-9a8f-2a1b34e2f1582025-11-17WarningsExact identifier
application number: M002
Gas Relief Ultra StrengthSIMETHICONEP & L Development, LLCcc2dd74a-9cdb-4162-9d05-2b9279f4a38e2025-11-17WarningsExact 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