FDA.reportPublic FDA data

mylanta gas

Product NDC
62372-554
11-digit product format
623720554
Labeler code
62372
Product ID
62372-554_ce925db4-fe1a-4069-96be-ce86cdd4e79a
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Infirst Healthcare
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-04-29
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
mylanta gas
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
ce925db4-fe1a-4069-96be-ce86cdd4e79aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62372-554-31mylanta gas3 in 1 CARTONCAPSULE, LIQUID FILLED31
62372-554-31mylanta gas10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED101

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 11 of 13 · 255 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Simethicone 80 mgSIMETHICONEProficient Rx LPa5e523b3-475e-4d28-a89c-c4325c59c9392024-10-01WarningsExact identifier
application number: M002
good sense gas reliefSIMETHICONEL. Perrigo Company14caaf5a-6877-40f9-af8f-fb48de94ecfe2024-09-30WarningsExact identifier
application number: M002
Care One Gas ReliefSIMETHICONEAmerican Sales Companyf42c8c2a-4ffd-465e-bb93-05ed65ba76f02024-09-15WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEPublix Super Markets Incaafa7da9-53d7-478a-805e-e68cdf54ed2b2024-09-14WarningsExact identifier
application number: M002
basic care gas reliefSIMETHICONEAmazon.com Services LLC6cd13797-207b-41fa-8dc1-5688f6b861492024-09-14WarningsExact identifier
application number: M002
meijer EXTRA STRENGTH Gas Relief SOFTGELSIMETHICONEMeijer, Inc.1befc6cb-a5ad-b950-e063-6394a90a5de32024-09-12WarningsExact identifier
application number: M002
meijer ULTRA STRENGTH Gas Relief SOFTGELSIMETHICONEMeijer, Inc.1bdbea4c-52f6-f855-e063-6394a90ae4fc2024-09-06WarningsExact identifier
application number: M002
Simethicone 125 mgSIMETHICONEProficient Rx LP078ef54e-96b2-4e2f-bebc-9b9bcda1f90a2024-09-01WarningsExact identifier
application number: M002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198852simethicone 125 MG Oral CapsulePSNce925db4-fe1a-4069-96be-ce86cdd4e79a1
198852simethicone 125 MG Oral CapsuleSCDce925db4-fe1a-4069-96be-ce86cdd4e79a1
198852dimethicone 125 MG Oral CapsuleSYce925db4-fe1a-4069-96be-ce86cdd4e79a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62372-554-31623720554313 BLISTER PACK in 1 CARTON (62372-554-31) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK3 blister pack2026-04-29NoNoCurrent