FDA.reportPublic FDA data

Simethicone 125 mg

Product NDC
69618-032
11-digit product format
696180032
Labeler code
69618
Product ID
69618-032_2bc80ff5-2de5-ff04-e063-6294a90a5026
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Reliable 1 Laboratires LLC
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-04-25
Substance
DIMETHICONE
Active strength
125 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 125 mg
Listing expiration
2026-12-31

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
314221Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
330aed4b-7109-09b8-e054-00144ff8d46cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69618-032-062023-03-29C16284748780-1f386c649-d93c-0266-e053-dadaa90a7c1aSimethicone 125 mg
69618-032-062023-01-30C16284748780-1f386c649-d93c-0266-e053-dadaa90a7c1aSimethicone 125 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69618-032-06Simethicone 125 mg60 in 1 BOTTLE, PLASTICTABLET, CHEWABLE609

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69618-032-06EA - Each69618-032aa923b1b-9112-453b-bc6f-c3e2956863ec12016-06-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69618-032SIMETHICONE 125 MG (SIMETHICONE) TABLET, CHEWABLE [RELIABLE 1 LABORATIRES LLC]9Current NDC, Legacy NDC, 1 package rows20250117_330aed4b-7109-09b8-e054-00144ff8d46c.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 6 of 13 · 255 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gas Relief Extra StrengthSIMETHICONEUnited Natural Foods, Inc. dba UNFIbdd7147b-dcb4-4aa0-a3a1-ec9ceaeec7872025-11-19WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEStrategic Sourcing Services LLCfa85df3f-243d-470b-ad28-82512e05fbbe2025-11-19WarningsExact identifier
application number: M002
Gas Relief Extra StrengthSIMETHICONEP & L Development, LLC4120832d-6c98-43f6-bdac-c88376c88c302025-11-17WarningsExact identifier
application number: M002
SIMETHICONESIMETHICONEGeri-Care Pharmaceuticals, Corpbe96ce05-dd74-4915-9a8f-2a1b34e2f1582025-11-17WarningsExact identifier
application number: M002
Gas Relief Ultra StrengthSIMETHICONEP & L Development, LLCcc2dd74a-9cdb-4162-9d05-2b9279f4a38e2025-11-17WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEMeijer Distribution, Inc.7723821e-b2fc-4c9c-a389-05184aaea19f2025-11-15WarningsExact identifier
application number: M002
TopCare Extra Strength Gas Relief Cherry CremeSIMETHICONETOPCO ASSOCIATES LLC4d1701fd-b797-4e95-9004-84d528941e722025-11-10WarningsExact identifier
application number: M002
up and up extra strength gas relief chewables Extra StrengthSIMETHICONETarget Corporation0a015c48-680c-4de1-91e7-1c1145239d8e2025-11-04WarningsExact identifier
application number: M002
Extra Strength Gas ReliefSIMETHICONESAFEWAYc8946bd2-6351-40e4-a139-d8214889bb4e2025-10-29WarningsExact identifier
application number: M002
Extra Strength Gas ReliefSIMETHICONE ANTIGASSAFEWAYcbbd43eb-1155-4e0d-bed4-32343f34b5032025-10-29WarningsExact identifier
application number: M002
meijer EXTRA STRENGTH Gas ReliefSIMETHICONEMeijer, Inc3e83bb0f-d909-08c3-e063-6294a90ae1382025-10-29WarningsExact identifier
application number: M002
PUBLIX Extra StrengthSIMETHICONEPUBLIX SUPER MARKETS, INC089d77c9-7aa0-4eee-8363-c47a2d5928cf2025-10-28WarningsExact identifier
application number: M002
Extra Strength gas reliefSIMETHICONEPUBLIX SUPER MARKETS, INC,029f9254-8cfd-4ea0-8691-2d87df4504332025-10-28WarningsExact identifier
application number: M002
Publix Infants Dye Free Gas ReliefSIMETHICONEPUBLIX SUPER MARKETS, INC2fe74800-a1f6-4774-9976-d6767ba34b492025-10-28WarningsExact identifier
application number: M002
Extra Strength Gas ReliefSIMETHICONEWal-Mart Stores,Inc.,e6087f04-20bf-402c-892b-e64f778b01442025-10-27WarningsExact identifier
application number: M002
Infants Gas Relief DropsSIMETHICONEWal-Mart Stores,Inc.,966f0506-c2d2-4d3c-bd2d-c5a6b1e0a1572025-10-27WarningsExact identifier
application number: M002
InfantsSIMETHICONERUGBY LABORATORIESc6fa71bc-de48-47f4-80c4-7d92643d26642025-10-25WarningsExact identifier
application number: M002
Meijer Extra Strength Gas ReliefSIMETHICONEMEIJER DISTRIBUTION INC1e8dc937-ad86-4560-bcc1-3f23fbfe8c642025-10-24WarningsExact identifier
application number: M002
Meijer Infants Gas Relief DropsSIMETHICONEMEIJER DISTRIBUTION INC.4493efcd-a547-4700-9e6a-a67d6420edb52025-10-24WarningsExact identifier
application number: M002
PHAZYMESIMETHICONEC.B. Fleet Company, Inc.ea04f5a5-cf56-4176-a234-5a73e01ff2182025-10-23WarningsExact identifier
application number: M002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314221simethicone 125 MG Chewable TabletPSN330aed4b-7109-09b8-e054-00144ff8d46c9
314221simethicone 125 MG Chewable TabletSCD330aed4b-7109-09b8-e054-00144ff8d46c9
314221simethicone 125 MG Chewable TabletPSN4ce98db3-c7a6-4627-88c5-9de302a531884
314221simethicone 125 MG Chewable TabletSCD4ce98db3-c7a6-4627-88c5-9de302a531884
314221simethicone 125 MG Chewable TabletPSN078ef54e-96b2-4e2f-bebc-9b9bcda1f90a1
314221simethicone 125 MG Chewable TabletSCD078ef54e-96b2-4e2f-bebc-9b9bcda1f90a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69618-032-066961800320660 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (69618-032-06) 2018-04-250000-00-00NoNoCurrent