FDA.reportPublic FDA data

Gas-X

Product NDC
0067-0117
11-digit product format
000670117
Labeler code
0067
Product ID
0067-0117_b5d94cf5-198b-4797-9de7-3014bcc12202
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-01-01
Substance
DIMETHICONE, UNSPECIFIED
Active strength
125 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
Extra Strength
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE, UNSPECIFIED125 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
210295Internal RxNorm lookup
314221Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7ce312ca-542b-4bc0-97b5-f65279e1e84cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0067-0117-01Gas-XExtra Strength12 in 1 BLISTER PACKTABLET, CHEWABLE128
0067-0117-01Gas-XExtra Strength6 in 1 CARTONTABLET, CHEWABLE68
0067-0117-18Gas-XExtra Strength9 in 1 BLISTER PACKTABLET, CHEWABLE98
0067-0117-18Gas-XExtra Strength2 in 1 CARTONTABLET, CHEWABLE28
0067-0117-27Gas-XExtra Strength9 in 1 BLISTER PACKTABLET, CHEWABLE98
0067-0117-27Gas-XExtra Strength3 in 1 CARTONTABLET, CHEWABLE38
0067-0117-48Gas-XExtra Strength12 in 1 BLISTER PACKTABLET, CHEWABLE128
0067-0117-48Gas-XExtra Strength4 in 1 CARTONTABLET, CHEWABLE48
0067-0117-49Gas-XExtra Strength12 in 1 BLISTER PACKTABLET, CHEWABLE128
0067-0117-49Gas-XExtra Strength5 in 1 CARTONTABLET, CHEWABLE58

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0067-0117-01EA - Each0067-011713e5a13e-d3e5-4b53-a0c5-df8dd8e01e0c12018-05-09
0067-0117-18EA - Each0067-0117a132cdcc-9c89-4a97-aaa2-ae4bb22d68a612012-07-24
0067-0117-48EA - Each0067-0117b4dfa93f-04fd-47a8-9791-32f39d7ec1cf12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1OGAS-X EXTRA STRENGTH (SIMETHICONE) TABLET, CHEWABLE [NOVARTIS CONSUMER HEALTH]3
DIMETHICONEACTIVE MOIETY92RU3N3Y1OGAS-X EXTRA STRENGTH (SIMETHICONE) TABLET, CHEWABLE [NOVARTIS CONSUMER HEALTH]3
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKGAS-X EXTRA STRENGTH (SIMETHICONE) TABLET, CHEWABLE [NOVARTIS CONSUMER HEALTH]3
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2GAS-X EXTRA STRENGTH (SIMETHICONE) TABLET, CHEWABLE [NOVARTIS CONSUMER HEALTH]3
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DGAS-X EXTRA STRENGTH (SIMETHICONE) TABLET, CHEWABLE [NOVARTIS CONSUMER HEALTH]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGAS-X EXTRA STRENGTH (SIMETHICONE) TABLET, CHEWABLE [NOVARTIS CONSUMER HEALTH]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0067-0117GAS-X EXTRA STRENGTH (SIMETHICONE) TABLET, CHEWABLE [HALEON US HOLDINGS LLC]8Current NDC, Legacy NDC, 10 package rows20241215_7ce312ca-542b-4bc0-97b5-f65279e1e84c.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 10 of 13 · 242 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SimethiconeSIMETHICONEHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd346df37d-b0fc-4fa5-8c19-492fed58c2392024-11-25WarningsExact identifier
application number: M002
Extra Strength Gas Relief CherrySIMETHICONERetail Business Services, LLC.1e8ed36d-5236-163b-e063-6294a90ad6ec2024-11-22WarningsExact identifier
application number: M002
SimethiconeSIMETHICONEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.0f9639fa-e1d0-460d-bc46-714a01cd98112024-11-21WarningsExact identifier
application number: M002
SimethiconeSIMETHICONEHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.852cec3b-6564-46b2-afe5-ecef314242372024-11-21WarningsExact identifier
application number: M002
Ultra Strength Gas ReliefSIMETHICONEWalgreen Co.d33e413d-4add-459f-ba46-c23b49cfcc872024-11-21WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEWalgreen Co.d87a20d4-dd1d-4897-9321-f81df2cfbcc72024-11-21WarningsExact identifier
application number: M002
Ultra Strength Gas ReliefSIMETHICONEWalgreen Co.b14b647f-d729-47df-879d-ca08a30b995e2024-11-21WarningsExact identifier
application number: M002
Ultra Strength Gas ReliefSIMETHICONEWal-Mart Stores Inc206d57ec-c854-496e-af53-7d8b2a208d852024-11-21WarningsExact identifier
application number: M002
SimethiconeSIMETHICONEWALGREEN CO.4d523979-e3ae-47e8-9092-00fdffc8bb0b2024-11-21WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEWal-Mart Stores Inc69351cf9-3092-45ca-8b84-83e3737fa8d42024-11-21WarningsExact identifier
application number: M002
SimethiconeSIMETHICONEWALMART INC.79a9e0a3-9199-4397-ab29-b8a9c843cdf82024-11-21WarningsExact identifier
application number: M002
Maximum Strength Gas ReliefSIMETHICONEFOODHOLD U.S.A., LLCc37def6e-bb10-41ba-8bce-b06c09edbe9f2024-11-21WarningsExact identifier
application number: M002
Gas Relief Ultra StrengthSIMETHICONE 180 MGHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.2cfb8132-6de4-457d-880b-c870a38862ad2024-11-20WarningsExact identifier
application number: M002
Gas-AidSIMETHICONELeosons Overseas Corpd271bfcb-bf13-4a97-bc03-f1824826f15a2024-11-19WarningsExact identifier
application number: M002
Gas-Aid Drops for infantsSIMETHICONELeosons Overseas Corp06665701-5f1c-4f8f-8775-e0a4a9ef20292024-11-19WarningsExact identifier
application number: M002
Mag-AL Plus XSALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND DIMETHICONEPAI Holdings, LLC dba PAI Pharmadb0c47ab-5296-4195-9fa6-2e338b6650942024-11-12WarningsExact identifier
application number: M002
basic care gas reliefSIMETHICONEAmazon.com Services LLCab1681df-aded-4b0c-9124-87196606183b2024-11-02WarningsExact identifier
application number: M002
Good Sense Gas Relief Extra StrengthSIMETHICONEL. Perrigo Company6b2d8591-cc58-457e-92b6-c719eee856052024-11-02WarningsExact identifier
application number: M002
premier value infants gas reliefSIMETHICONEChain Drug Consortium7b887e53-a70a-4f33-9472-e1175b24400a2024-10-28WarningsExact identifier
application number: M002
Premier Value Extra StrengthSIMETHICONEPHARMACY VALUE ALLIANCE, LLCdf2b1b62-5bd2-4d02-86c2-537b965a8d202024-10-28WarningsExact identifier
application number: M002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
210295Gas-X Extra Strength 125 MG Chewable TabletPSN7ce312ca-542b-4bc0-97b5-f65279e1e84c8
314221simethicone 125 MG Chewable TabletPSN7ce312ca-542b-4bc0-97b5-f65279e1e84c8
210295simethicone 125 MG Chewable Tablet [Gas-X]SBD7ce312ca-542b-4bc0-97b5-f65279e1e84c8
314221simethicone 125 MG Chewable TabletSCD7ce312ca-542b-4bc0-97b5-f65279e1e84c8
210295Gas-X 125 MG Chewable TabletSY7ce312ca-542b-4bc0-97b5-f65279e1e84c8
210295Gas-X Extra Strength 125 MG Chewable TabletSY7ce312ca-542b-4bc0-97b5-f65279e1e84c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0067-0117-01000670117016 BLISTER PACK in 1 CARTON (0067-0117-01) / 12 TABLET, CHEWABLE in 1 BLISTER PACK6 blister pack2012-01-010000-00-00NoNoCurrent
0067-0117-18000670117182 BLISTER PACK in 1 CARTON (0067-0117-18) / 9 TABLET, CHEWABLE in 1 BLISTER PACK2 blister pack2012-01-010000-00-00NoNoCurrent
0067-0117-27000670117273 BLISTER PACK in 1 CARTON (0067-0117-27) / 9 TABLET, CHEWABLE in 1 BLISTER PACK3 blister pack2012-01-010000-00-00NoNoCurrent
0067-0117-48000670117484 BLISTER PACK in 1 CARTON (0067-0117-48) / 12 TABLET, CHEWABLE in 1 BLISTER PACK4 blister pack2012-01-010000-00-00NoNoCurrent
0067-0117-49000670117495 BLISTER PACK in 1 CARTON (0067-0117-49) / 12 TABLET, CHEWABLE in 1 BLISTER PACK5 blister pack2012-01-010000-00-00NoNoCurrent