FDA.reportPublic FDA data

SIMETHICONE

Product NDC
57896-791
11-digit product format
578960791
Labeler code
57896
Product ID
57896-791_43d043e1-1f90-dc96-e063-6294a90addfb
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Geri-Care Pharmaceuticals, Corp
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2004-01-01
Substance
DIMETHICONE
Active strength
80 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
SIMETHICONE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE80 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
314216Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
be96ce05-dd74-4915-9a8f-2a1b34e2f158Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57896-791-01SIMETHICONE100 in 1 BOTTLETABLET, CHEWABLE1007
57896-791-08SIMETHICONE80 in 1 BOTTLETABLET, CHEWABLE807

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-791-01EA - Each57896-791d7abb991-f273-4ad8-8ac3-e1239c002ec012014-12-01
57896-791-08EA - Each57896-791c9e325d9-2782-4318-861b-0e093f6d3dfd12022-02-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1OSIMETHICONE TABLET, CHEWABLE [GERI-CARE PHARMACEUTICALS, CORP]1
DIMETHICONEACTIVE MOIETY92RU3N3Y1OSIMETHICONE TABLET, CHEWABLE [GERI-CARE PHARMACEUTICALS, CORP]1
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2SIMETHICONE TABLET, CHEWABLE [GERI-CARE PHARMACEUTICALS, CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SIMETHICONE TABLET, CHEWABLE [GERI-CARE PHARMACEUTICALS, CORP]1
SORBITOLINACTIVE INGREDIENT506T60A25RSIMETHICONE TABLET, CHEWABLE [GERI-CARE PHARMACEUTICALS, CORP]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSIMETHICONE TABLET, CHEWABLE [GERI-CARE PHARMACEUTICALS, CORP]1
TALCINACTIVE INGREDIENT7SEV7J4R1USIMETHICONE TABLET, CHEWABLE [GERI-CARE PHARMACEUTICALS, CORP]1
TRICALCIUM PHOSPHATEINACTIVE INGREDIENTK4C08XP666SIMETHICONE TABLET, CHEWABLE [GERI-CARE PHARMACEUTICALS, CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57896-791SIMETHICONE TABLET, CHEWABLE [GERI-CARE PHARMACEUTICALS, CORP]6Current NDC, Legacy NDC, 2 package rows20241204_be96ce05-dd74-4915-9a8f-2a1b34e2f158.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
314216simethicone 80 MG Chewable TabletPSNbe96ce05-dd74-4915-9a8f-2a1b34e2f1587
314216simethicone 80 MG Chewable TabletSCDbe96ce05-dd74-4915-9a8f-2a1b34e2f1587
314216simethicone 80 MG Chewable TabletPSNe07aebe8-3c58-4bf0-9e80-66d430e2de9b6
314216simethicone 80 MG Chewable TabletSCDe07aebe8-3c58-4bf0-9e80-66d430e2de9b6
314216simethicone 80 MG Chewable TabletPSN5df94be7-0bc9-4be1-9982-8193e3a3c8ef3
314216simethicone 80 MG Chewable TabletSCD5df94be7-0bc9-4be1-9982-8193e3a3c8ef3
314216simethicone 80 MG Chewable TabletPSNe07f6acc-1b75-d8eb-e053-2a95a90a7d9b2
314216simethicone 80 MG Chewable TabletSCDe07f6acc-1b75-d8eb-e053-2a95a90a7d9b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57896-791-0157896079101100 TABLET, CHEWABLE in 1 BOTTLE (57896-791-01) 2016-09-010000-00-00NoNoCurrent
57896-791-085789607910880 TABLET, CHEWABLE in 1 BOTTLE (57896-791-08) 2021-08-010000-00-00NoNoCurrent