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 20 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Ultra Strength AntacidCALCIUM CARBONATECARDINAL HEALTH 110, LLC. DBA LEADEReab5a905-67fb-494e-8f55-aeeab4c2dce22025-08-22WarningsExact identifier
application number: M001
Leader Extra Strength AntacidCALCIUM CARBONATECARDINAL HEALTH 110, LLC. DBA LEADER81911f6d-7edf-4183-9720-2f20a5db498d2025-08-21WarningsExact identifier
application number: M001
Gas ReliefSIMETHICONEBJWC (Berkley & Jensen / BJ's)2f32dde8-502e-eefa-e063-6294a90abf202025-08-19WarningsExact identifier
application number: M001
CVS Health Ultra Strength Natural Antacid Peppermint FlavorANTACID TABLETSCVS Pharmacy,Inc.4f18fd8d-4d6a-4b1d-8a94-b64592f73ad02025-08-13WarningsExact identifier
application number: M001
MGC Health Calcium Carbonate Antacid Assorted BerriesCALCIUM CARBONATEXiamen Kang Zhongyuan Biotechnology Co., Ltd.b84d80c6-0240-4276-8e47-74a918f3d86a2025-08-12WarningsExact identifier
application number: M001
AntacidCALCIUM CARBONATEProStat First Aid3bb49eb3-2eaa-af8d-e063-6294a90a40352025-08-06WarningsExact identifier
application number: M001
Maximum Strength Antacid and AntigasALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEMeijer, Inc.30a0455d-63e0-95cc-e063-6394a90ada6b2025-07-30WarningsExact identifier
application number: M001
Sodium Bicarbonate AntacidSODIUM BICARBONATEMenper Distributors Inc.6efb4da0-03ae-4df6-acd7-e8023d20d4b32025-07-22WarningsExact identifier
application number: M001
Gas-X Total Relief Maximum StrengthCALCIUM CARBONATE, SIMETHICONEHaleon US Holdings LLCedb0f11a-bdb7-484d-9257-09ff47b0fca42025-07-15WarningsExact identifier
application number: M001
REGULAR STRENGTH ANTACID ANTIGASALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEWALGREEN COMPANY7cd9234e-d1cc-4cce-e053-2991aa0a457e2025-07-09WarningsExact identifier
application number: M001
Sodium BicarbonateSODIUM BICARBONATEWestminster Pharmaceuticals, LLC9dcfc778-5fd6-4c68-8d37-a5385e3746172025-07-08WarningsExact identifier
application number: M001
MGC Health Antacid Soft Chews Cherry FlavorCALCIUM CARBONATEXiamen Kang Zhongyuan Biotechnology Co., Ltd.3958ec0a-8f32-6918-e063-6294a90ac1c42025-07-07WarningsExact identifier
application number: M001
Aluminum Hydroxide, Magnesium Hydroxide, and SimethiconeALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONEMajor Pharmaceuticals1bc90fa7-fcce-4a9b-862f-f30ab602ecab2025-07-07WarningsExact identifier
application number: M001
KOSHER MEDS antacidCALCIUM CARBONATEMollec Inc7783d6a2-56e3-4542-ad1d-60680e03532b2025-07-01WarningsExact identifier
application number: M001
Nauzene Chewables Ginger HoneySODIUM CITRATEKobayashi Healthcare International, Inc.25c9825d-a4e8-4671-e063-6294a90ab46d2025-06-24WarningsExact identifier
application number: M001
Gaviscon Extra StrengthALUMINUM HYDROXIDE AND MAGNESIUM CARBONATEHaleon US Holdings LLC7f367927-c366-465c-a059-e2cfb337d5622025-06-11WarningsExact identifier
application number: M001
Calmicid AC Acid ReducerFAMOTIDINEMelaleuca, Inc.369ae213-cd23-57ba-e063-6394a90a87a62025-06-02WarningsExact identifier
application number: M001
Aluminum Hydroxide, Magnesium Hydroxide, and SimethiconeALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND SIMETHICONEAmerican Health Packaging2faf291e-1d62-412a-a05e-e992cb7def6a2025-05-30WarningsExact identifier
application number: M001
Kids Tummy ReliefCALCIUM CARBONATEGenexa Inc.a7831b84-1f51-9258-e053-2a95a90a901e2025-05-23WarningsExact identifier
application number: M001
Calcium CarbonateCALCIUM CARBONATEAtlantic Biologicals Corps38654d22-2f8a-49d2-a1cd-06d341f113232025-05-12WarningsExact 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