FDA.reportPublic FDA data

Gas Relief

Product NDC
37808-797
11-digit product format
378080797
Labeler code
37808
Product ID
37808-797_dd0b9f77-06e9-4eca-bc6d-4a6c57a62e15
Type
HUMAN OTC DRUG
Nonproprietary name
SIMETHICONE
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
H E B
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-03-26
Substance
DIMETHICONE
Active strength
125 mg/1
Pharmacologic classes
Skin Barrier Activity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
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 Relief
Brand name suffix
Extra Strength
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE125 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
198852Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c153585f-0f44-40ad-8246-5d9edae8325eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-797-10Gas ReliefExtra Strength100 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-797GAS RELIEF EXTRA STRENGTH (SIMETHICONE) CAPSULE, LIQUID FILLED [H E B]3Current NDC, Legacy NDC, 1 package rows20240410_c153585f-0f44-40ad-8246-5d9edae8325e.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 7 of 13 · 242 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Curist Gas ReliefSIMETHICONELittle Pharma. Inc.3948c0e5-4ee7-5443-e063-6294a90ad6ae2025-07-06WarningsExact identifier
application number: M002
Simethicone 125 mgSIMETHICONEATLANTIC BIOLOGICALS CORP.4ce98db3-c7a6-4627-88c5-9de302a531882025-06-27WarningsExact identifier
application number: M002
GNP Regular Strength Gas ReliefDIMETHICONEATLANTIC BIOLOGICALS CORP.b31257ef-489b-4067-9cc6-8a593d9839582025-06-24WarningsExact identifier
application number: M002
Gas-X Ultimate Strength SoftgelsSIMETHICONEHaleon US Holdings LLC24b777e5-f0b5-400d-8ca9-ae0c04b8503b2025-05-20WarningsExact identifier
application number: M002
EXTRA STRENGTH GAS RELIEFSIMETHICONEGeri-Care Pharmaceuticals, Corpb6223134-8a2e-d1ec-e053-2995a90a90772025-04-28WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONE 125 MGPioneer Life Sciences, LLC21e11fe0-b3b9-42f6-a698-9cdc1a6d82bb2025-04-23WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONE 125 MGNUVICARE LLC5c6352b9-fd8a-4876-b089-e4c1d15cd2642025-04-23WarningsExact identifier
application number: M002
Gas Relief - Cherry FlavorSIMETHICONETARGET CORPORATION290fe08d-a0b9-82f7-e063-6394a90a9c752025-04-11WarningsExact identifier
application number: M002
InfantsSIMETHICONEATLANTIC BIOLOGICALS CORP.27fce442-e328-41d2-bab9-87ab21550c042025-04-11WarningsExact identifier
application number: M002
Infants Non staining Gas reliefSIMETHICONERetail Business Services, LLC.1501bee6-4734-4836-8573-54af919d42212025-02-27WarningsExact identifier
application number: M002
Gas-X Extra StrengthSIMETHICONEHaleon US Holdings LLCf553374b-c20e-4c92-a8c0-cef0aeda8d1c2025-02-26WarningsExact identifier
application number: M002
Extra Strength Gas Relief Cherry FlavorSIMETHICONEDiscount Drug Mart, Inc2df821f6-e4b5-89ae-e063-6394a90ad4162025-02-24WarningsExact identifier
application number: M002
Gas reliefSIMETHICONEDiscount Drug Mart, Inc2df9117a-97cc-532d-e063-6294a90a1a9c2025-02-20WarningsExact identifier
application number: M002
Alcohol prep padALCOHOL PREP PADTarget Corporationbc9a4f33-3eec-79e3-e053-2a95a90a90172025-02-19WarningsExact identifier
application number: M002
Ultra Strength Gas ReliefSIMETHICONEBETTER LIVING BRANDS, LLCeb4bef2c-15dd-434a-e053-2a95a90a616f2025-02-12WarningsExact identifier
application number: M002
Regular Strength Antacid AntigasALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONEHarris Teeter, LLC2c503a99-91da-59f3-e063-6394a90a32ba2025-02-12WarningsExact identifier
application number: M002
Ultra Strength Gas ReliefSIMETHICONEKROGER COMPANYea1c4aa8-bde6-2072-e053-2995a90a93ba2025-02-10WarningsExact identifier
application number: M002
Gas Relief SIMETHICONE 250 mg Anti-gasSIMETHICONECVS Pharmacy, Inc.63dbc39e-2ba8-4435-9093-d1ad2eb3e8d52025-02-06WarningsExact identifier
application number: M002
Extra Strength Gas Relief CherrySIMETHICONEH E B1894fa42-4aaf-2d17-e063-6394a90a39622025-02-06WarningsExact identifier
application number: M002
Gas reliefSIMETHICONEGuardian Drug Companya5c7c175-1fb7-4b4b-9ba1-b1df1251305c2025-02-06WarningsExact identifier
application number: M002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198852simethicone 125 MG Oral CapsulePSNc153585f-0f44-40ad-8246-5d9edae8325e5
198852simethicone 125 MG Oral CapsuleSCDc153585f-0f44-40ad-8246-5d9edae8325e5
198852dimethicone 125 MG Oral CapsuleSYc153585f-0f44-40ad-8246-5d9edae8325e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
37808-797-1037808079710100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (37808-797-10) 2021-03-260000-00-00NoNoCurrent