FDA.reportPublic FDA data

Gas-X

Product NDC
0067-6283
11-digit product format
000676283
Labeler code
0067
Product ID
0067-6283_155aa0c5-6407-ee86-e063-6294a90a1c4d
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
M001
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-03-10
Substance
DIMETHICONE
Active strength
250 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
Maximum Strength Softgels
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE250 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
412111Internal RxNorm lookup
2119393Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
45d1e373-0717-47df-9160-619c451666f4Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0067-6283-01Gas-XMaximum Strength Softgels10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED107
0067-6283-01Gas-XMaximum Strength Softgels3 in 1 CARTONCAPSULE, LIQUID FILLED37
0067-6283-02Gas-XMaximum Strength Softgels5 in 1 CARTONCAPSULE, LIQUID FILLED57
0067-6283-02Gas-XMaximum Strength Softgels10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0067-6283-01EA - Each0067-628334befb20-b7d6-4a8a-8844-58ad1ceeabf012024-11-05
0067-6283-02EA - Each0067-62836b0d07bc-c6ff-4b22-a68c-45e4166246e412025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0067-6283GAS-X MAXIMUM STRENGTH SOFTGELS (SIMETHICONE) CAPSULE, LIQUID FILLED [HALEON US HOLDINGS LLC]7Current NDC, Legacy NDC, 4 package rows20240406_45d1e373-0717-47df-9160-619c451666f4.zip

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 21 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GERI-LANTA ANTACID ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEATLANTIC BIOLOGICALS CORP.043207dd-5e1c-4c78-b75a-7d341d71b1172025-05-12WarningsExact identifier
application number: M001
Calcium CarbonateANTACIDAllegiant Health5397b702-5920-4af9-8cc5-e7fe6e2c10212025-05-01WarningsExact identifier
application number: M001
Caring Mill AntacidCARING MILL ANTACID CHERRY FLAVOR SOFT CHEWSXiamen Kang Zhongyuan Biotechnology Co., Ltd.2669b4f9-82c6-8a39-e063-6394a90a0fd42025-04-30WarningsExact identifier
application number: M001
NauzeneSODIUM CITRATEKobayashi Healthcare International, Inc.a60660b2-c5db-45a0-885f-de93e655380d2025-04-29WarningsExact identifier
application number: M001
Calcium Carbonate Antacid Assorted BerriesCALCIUM CARBONATEFSA STORE INC.e07b3ec8-c2c7-41da-8374-12fe9f09d8562025-04-18WarningsExact identifier
application number: M001
Mag 440MEGNESIUM OXIDEAllegis Pharmaceuticals, LLC2cb19dc0-115b-38b8-e063-6294a90a4aea2025-04-17WarningsExact identifier
application number: M001
Rolaids Advanced Antacid Anti-gas Mixed BerryCALCIUM CARBONATE AND MAGNESIUM HYDROXIDE AND SIMETHICONEChattem, Inc.3884c05a-a593-424e-88b3-be962e73488e2025-04-10WarningsExact identifier
application number: M001
Kroger Wild Berry Antacid ChewsCALCIUM CARBONATEKroger326e3775-d7f9-2fd9-e063-6294a90a059b2025-04-10WarningsExact identifier
application number: M001
Calcium Carbonate 750 mgCALCIUM CARBONATE 750 MG - ASSORTED BERRIESCVS Pharmacy.Inc.23a76a4f-8c41-b9d0-e063-6394a90a19c52025-04-09WarningsExact identifier
application number: M001
BERKLEY JENSEN ULTRA STRENGTHANTACID CALCIUM CARBONATEBJWCc7eedcbf-3b07-4cd3-937b-c56d7cc5bc572025-04-08WarningsExact identifier
application number: M001
Extra Strength Antacid Smooth Dissolving - Assorted FruitCALCIUM CARBONATETARGET CORPORATION28fc38a7-f7a0-a6a5-e063-6294a90af94c2025-04-05WarningsExact identifier
application number: M001
Extra Strength Antacid Smooth dissolving - Berry Fusion FlavorsCALCIUM CARBONATETARGET CORPORATION28fce33f-c561-1512-e063-6294a90a111c2025-04-05WarningsExact identifier
application number: M001
Alka-Seltzer Heartburn Relief Lemon LimeANHYDROUS CITRIC ACID, SODIUM BICARBONATE (HEAT-TREATED)Bayer Healthcare LLCcc21af24-9a5b-6831-e053-2a95a90a0af42025-04-01WarningsExact identifier
application number: M001
Magnesium OxideMAGNESIUM OXIDEBelleview Biosciences31bc45c7-ba92-bad0-e063-6394a90a9af82025-04-01WarningsExact identifier
application number: M001
KO-LANTAALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, DIMETHICONEGeri-Care Pharmaceuticals, Corp31a6011d-5c61-d0fe-e063-6294a90ac5892025-03-31WarningsExact identifier
application number: M001
Ultra Strength Antacid Assorted BerriesCALCIUM CARBONATERite Aid840a617d-d006-4a9b-b98a-8a5ed9af0f402025-03-31WarningsExact identifier
application number: M001
Ultra Strength Antacid PeppermintCALCIUM CARBONATERite Aid3cb46f74-7a62-4b27-beac-a3c055a282152025-03-31WarningsExact identifier
application number: M001
Calcium Carbonate 1000 mgCALCIUM CARBONATE 1000 MG - TROPICAL FRUITCVS HEALTH CORP24ceba32-eb32-902f-e063-6394a90a9fd52025-03-28WarningsExact identifier
application number: M001
Extra Strength Antacid Assorted BerriesCALCIUM CARBONATERite Aidb1af099d-4095-4bd7-a23c-ad85e92513d82025-03-28WarningsExact identifier
application number: M001
Extra Strength Antacid Orange Cream Sugar FreeCALCIUM CARBONATERite Aid089a1cd5-954e-4c3f-ab4b-cac693a1d44a2025-03-28WarningsExact identifier
application number: M001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2119393Gas-X 250 MG Oral CapsulePSN45d1e373-0717-47df-9160-619c451666f47
412111simethicone 250 MG Oral CapsulePSN45d1e373-0717-47df-9160-619c451666f47
2119393simethicone 250 MG Oral Capsule [Gas-X]SBD45d1e373-0717-47df-9160-619c451666f47
412111simethicone 250 MG Oral CapsuleSCD45d1e373-0717-47df-9160-619c451666f47
412111dimethicone 250 MG Oral CapsuleSY45d1e373-0717-47df-9160-619c451666f47
2119393Gas-X 250 MG Oral CapsuleSY45d1e373-0717-47df-9160-619c451666f47

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0067-6283-01000676283013 BLISTER PACK in 1 CARTON (0067-6283-01) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK3 blister pack2019-03-100000-00-00NoNoCurrent
0067-6283-02000676283025 BLISTER PACK in 1 CARTON (0067-6283-02) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK5 blister pack2021-03-310000-00-00NoNoCurrent