FDA.reportPublic FDA data

good sense gas relief

Product NDC
0113-0657
11-digit product format
001130657
Labeler code
0113
Product ID
0113-0657_587a6ecb-4daa-44d9-8c94-c1240a48b336
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
L. Perrigo Company
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2002-04-05
Substance
DIMETHICONE
Active strength
180 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
good sense gas relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE180 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
252294Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
14caaf5a-6877-40f9-af8f-fb48de94ecfeAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0113-0657-72good sense gas relief60 in 1 BOTTLECAPSULE, LIQUID FILLED603
0113-0657-72good sense gas relief1 in 1 CARTONCAPSULE, LIQUID FILLED13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-0657-72EA - Each0113-065779fc1650-ff01-4981-a9c8-c29e29eed1b012013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1OGOOD SENSE GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [L PERRIGO COMPANY]1
DIMETHICONEACTIVE MOIETY92RU3N3Y1OGOOD SENSE GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [L PERRIGO COMPANY]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAGOOD SENSE GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [L PERRIGO COMPANY]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8GOOD SENSE GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [L PERRIGO COMPANY]1
GELATININACTIVE INGREDIENT2G86QN327LGOOD SENSE GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [L PERRIGO COMPANY]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXGOOD SENSE GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [L PERRIGO COMPANY]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4GOOD SENSE GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [L PERRIGO COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-0657GOOD SENSE GAS RELIEF (SIMETHICONE) CAPSULE, LIQUID FILLED [L. PERRIGO COMPANY]3Current NDC, Legacy NDC, 2 package rows20241001_14caaf5a-6877-40f9-af8f-fb48de94ecfe.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
252294simethicone 180 MG Oral CapsulePSN14caaf5a-6877-40f9-af8f-fb48de94ecfe3
252294simethicone 180 MG Oral CapsuleSCD14caaf5a-6877-40f9-af8f-fb48de94ecfe3
252294dimethicone 180 MG Oral CapsuleSY14caaf5a-6877-40f9-af8f-fb48de94ecfe3
252294simethicone 180 MG Oral CapsulePSN06836246-9058-42af-a8a3-5aec81f4b9cc1
252294simethicone 180 MG Oral CapsuleSCD06836246-9058-42af-a8a3-5aec81f4b9cc1
252294dimethicone 180 MG Oral CapsuleSY06836246-9058-42af-a8a3-5aec81f4b9cc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-0657-72001130657721 BOTTLE in 1 CARTON (0113-0657-72) / 60 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2002-04-050000-00-00NoNoCurrent