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 4 of 13 · 242 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gas Relief Extra StrengthSIMETHICONEEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)ea6e04dd-4f57-4a88-b269-af38732915b32026-03-19WarningsExact identifier
application number: M002
SIMETHICONE INFANT Gas Relief DropsSIMETHICONEAtlantic Biologicals Corp.4d658287-358f-d358-e063-6294a90a4bd32026-03-19WarningsExact identifier
application number: M002
SIMETHICONE INFANT Gas Relief DropsSIMETHICONEAtlantic Biologicals Corp.410d80fc-e55b-08d0-e063-6294a90aba732026-03-18WarningsExact identifier
application number: M002
Gas Relief Extra StrengthSIMETHICONEWalgreensafcabb34-4ef4-4938-860f-154c204fcd482026-03-10WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONE 125 MGPioneer Life Sciences, LLC2c7bac92-4596-40aa-a2f2-4ebe380f1f2f2026-03-10WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONE 125 MGPioneer Life Sciences, LLC51dc6493-2f9f-4148-be7d-abfef1b251122026-03-10WarningsExact identifier
application number: M002
Gas Relief Extra StrengthSIMETHICONETOP CARE (Topco Associates LLC)ed8a723a-7dac-4670-8f02-f4154e0a36c92026-03-02WarningsExact identifier
application number: M002
Extra Strength Gas ReliefSIMETHICONEShield Pharmaceuticals Corpfafb57da-0682-475e-8ff9-17f2182129ef2026-02-24WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONE 180 MGPioneer Life Sciences, LLCf5284b68-f167-41d4-8b2f-ae7bafae0f4c2026-02-13WarningsExact identifier
application number: M002
SFEIXE ANTIFUNGAL PENUNDECYLENIC ACIDZhejiang JOOZENA Medical Technology Co., Ltd.455ad304-86bc-0abe-e063-6294a90a5b432026-02-12WarningsExact identifier
application number: M002
Gas Relief Ultimate Strength SoftgelsSIMETHICONEAdvanced Rx LLC5d412711-efd3-4b27-bfde-6fee2f460f8b2026-02-01WarningsExact identifier
application number: M002
QUITA COLICOS Gas RELIEF DropsSIMETHICONEDLC Laboratories, Inc.d4b0fa36-5925-4a6f-b3c9-0c785503976f2026-01-07WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONESafeway, Inc.7ecfe412-6a58-4dff-a52e-2e02a03426f92026-01-05WarningsExact identifier
application number: M002
Simethicone 180 MGSIMETHICONE 180 MGFarmacias De Similares TX LLC4b2166f7-8d98-dd76-e063-6394a90a7f0f2026-01-01WarningsExact identifier
application number: M002
Target Gas Relief Chews Mixed Berry and StrawberrySIMETHICONETarget11fd2ccd-3a2b-c141-e063-6394a90ab34f2025-12-20WarningsExact identifier
application number: M002
Gas Relief Simethicone 125mg SoftgelSIMETHICONENUVICARE LLCb774c8e6-e68e-4a13-834d-7eba34c5c3e02025-12-19WarningsExact identifier
application number: M002
Gas Relief Simethicone 180mg SoftgelSIMETHICONENUVICARE LLC51484644-eb45-4282-91c6-289169bcbaf62025-12-19WarningsExact identifier
application number: M002
EXTRA STRENGTH gas reliefSIMETHICONEKRAMER LABORATORIESd45ec9d0-f8b9-41ef-8dd9-11caf6a1b3eb2025-12-19WarningsExact identifier
application number: M002
SIMETHICONE 80MGSIMETHICONECardinal Health 107, LLC5e755184-0821-4f92-8f72-84726f7aa4072025-12-18WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONE CAPSULES USP, 125 MGDr. Reddy's Laboratories Inc.b3069d83-5654-8469-302a-0f76c30e39762025-12-15WarningsExact 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