Firstcare Gas Relief Simethicone 250 mg Anti-gas

Product NDC
71594-711
11-digit product format
715940711
Labeler code
71594
Product ID
71594-711_51a2e433-3a3e-b1e9-e063-6394a90a0a83
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone 250 mg
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
USpharma Ltd
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-05-12
Substance
DIMETHICONE
Active strength
250 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
Firstcare Gas Relief Simethicone 250 mg Anti-gas
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE250 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
2595235Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9625a697-fadc-483b-b83a-fa2cc76002baAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71594-711-15Firstcare Gas Relief Simethicone 250 mg Anti-gas48 in 1 BOTTLE, PLASTICTABLET, CHEWABLE481

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 12 of 13 · 241 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gas-X Ultra Strength AntiGas SoftgelsSIMETHICONEHaleon US Holdings LLCee9a8404-0653-433f-90e5-7ac69bdab8df2024-04-05WarningsExact identifier
application number: M002
Gas Relief Ultra StrengthSIMETHICONECVS Pharmacybac06147-87ae-4aaa-a66b-4aeae6096d8d2024-03-13WarningsExact identifier
application number: M002
Maximum Strength Gas ReliefSIMETHICONEWALGREENS03bc9c99-2871-2604-e063-6394a90a2be52024-03-06WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEBest Choice (Valu Merchandisers Company)23eda70b-ff1e-4b4e-9f9e-034ef101cd682024-02-20WarningsExact identifier
application number: M002
Anti-Gas Ultra StrengthSIMETHICONEBest Choice (Valu Merchandisers Company)f74d9882-cc99-41b6-b851-ce89d28f33df2024-02-15WarningsExact identifier
application number: M002
Right Remedies Maximum Strength Gas Relief SoftgelSIMETHICONEStrive Pharmaceuticals Inc.032b3a89-1bc4-4f38-ba9e-0a48402153302024-02-05WarningsExact identifier
application number: M002
Maximum Strength Gas Relief SoftgelSIMETHICONECardinal Health 110, LLC. DBA Leader57043cae-a8db-4eff-835c-5995e8aea9242024-01-11WarningsExact identifier
application number: M002
GAS RELIEF EXTRA STRENGTHSIMETHICONEYYBA CORPcc79435e-6d4b-b283-e053-2995a90a8db32024-01-03WarningsExact identifier
application number: M002
Childrens Mylicon All in One Tummy Relief for KidsANTACID AND ANTIGASInfirst Healthcare Inc.0952eba8-6de2-4a77-956d-339fab4374722024-01-01WarningsExact identifier
application number: M002
Mylicon Infants Gas Relief OriginalSIMETHICONEInfirst Healthcare395be942-d883-4bcb-8811-6fe1521d5a922024-01-01WarningsExact identifier
application number: M002
Mylicon Infants Gas Relief Dye FreeSIMETHICONEInfirst Healthcare3324139a-ed22-43af-859d-e7af19a24ee92024-01-01WarningsExact identifier
application number: M002
Mylanta Gas Minis Mint FlavorSIMETHICONEInfirst Healthcare Inc.5045b945-23ee-4c25-a32c-af3cd5045c732023-12-04WarningsExact identifier
application number: M002
Mylanta Gas Minis Assorted Fruit FlavorSIMETHICONEInfirst Healthcare Inc.c6db9af2-d457-477d-baa9-470ddbba59052023-12-04WarningsExact identifier
application number: M002
Childrens Mylicon Tummy Relief for KidsANTACID AND ANTIGASInfirst Healthcare Inc.432d5b4c-a69b-45f9-b7f0-216726a3eead2023-12-01WarningsExact identifier
application number: M002
INFANTS GAS RELIEFSIMETHICONEGeri-Care Pharmaceuticals, Corp5e08709c-846a-7f13-e053-2991aa0a09a62023-11-01WarningsExact identifier
application number: M002
GAS RELIEFSIMETHICONESTRATEGIC SOURCING SERVICES LLCff1fd97c-af4f-dffb-e053-6294a90a20392023-10-26WarningsExact identifier
application number: M002
INFANT GAS RELIEFSIMETHICONEAMERISOURCEBERGEN DRUG CORPORATION7d3c3cc6-b0a2-620d-e053-2a91aa0a159b2023-07-18WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEAllegiant Healthae98861e-6a26-4e0e-a66a-b2738d3cbddd2021-09-24WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEAllegiant Health4c79535c-4372-4fd4-a91a-d93617cd581b2021-09-24WarningsExact identifier
application number: M002
Anti-GasSIMETHICONEAllegiant Health7731bd63-667e-4fed-b446-92a4a83b66d62020-11-03WarningsExact identifier
application number: M002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2595235simethicone 250 MG Chewable TabletPSN9625a697-fadc-483b-b83a-fa2cc76002ba1
2595235simethicone 250 MG Chewable TabletSCD9625a697-fadc-483b-b83a-fa2cc76002ba1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71594-711-157159407111548 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (71594-711-15) 2026-05-12NoNoCurrent