Simethicone 125 mg

Product NDC
17856-0137
Requested package NDC
17856-0137-2
11-digit product format
178560137
Labeler code
17856
Product ID
17856-0137_38930d1f-1f60-1fa5-e063-6394a90a5c21
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
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
4ce98db3-c7a6-4627-88c5-9de302a53188Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-0137-12025-04-03C16284748780-11030e364-fccf-111a-e063-dadaa90a10e2Simethicone 125 mg
17856-0137-12024-01-30C16284748780-11030e364-fccf-111a-e063-dadaa90a10e2Simethicone 125 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0137-1Simethicone 125 mg100 in 1 BOX, UNIT-DOSETABLET, CHEWABLE1004
17856-0137-1Simethicone 125 mg1 in 1 POUCHTABLET, CHEWABLE14
17856-0137-2Simethicone 125 mg1 in 1 POUCHTABLET, CHEWABLE14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0137SIMETHICONE 125 MG (SIMETHICONE) TABLET, CHEWABLE [ATLANTIC BIOLOGICALS CORP.]3Current NDC, Legacy NDC, 3 package rows20250406_4ce98db3-c7a6-4627-88c5-9de302a53188.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 · 242 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
PHAZYMESIMETHICONEC.B. Fleet Company, Inc.ea04f5a5-cf56-4176-a234-5a73e01ff2182025-10-23WarningsExact identifier
application number: M002
Cardinal Health Infants Gas ReliefSIMETHICONECARDINAL HEALTHe0dec270-dabb-4289-b5e0-bf37f9ddcbcd2025-10-14WarningsExact identifier
application number: M002
Quality Choice Infants Gas Relief Dye FreeSIMETHICONEQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)841b85ef-2ac8-4dac-8659-cffb7e1b1e052025-08-23WarningsExact identifier
application number: M002
CVS Health Gas Relief SOFTGELSIMETHICONECVS Pharmacy, Inc2911cac8-45ec-1294-e063-6294a90a4a742025-08-22WarningsExact identifier
application number: M002
TopCare health EXTRA STRENGTH Gas Relief SOFTGELSIMETHICONETopco Associates LLC2ea0eb22-f679-d136-e063-6294a90a1dfe2025-08-01WarningsExact identifier
application number: M002
SIMETHICONE INFANT Gas Relief DropsSIMETHICONEAARNA USA Inc.9b0fde90-35ae-498e-99cc-d120f1a871822025-07-29WarningsExact identifier
application number: M002
Gas Relief Ultra StrengthSIMETHICONERugby Laboratories, Inc.24731f4b-ca2b-483f-beed-dfc8104f81332025-07-18WarningsExact identifier
application number: M002
Aluminum Hydroxide, Magnesium Hydroxide, and DimethiconeALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, AND DIMETHICONEAmerican Health Packaging23539e7e-a723-460f-892f-dac5bbbb9b162025-07-15WarningsExact identifier
application number: M002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314221simethicone 125 MG Chewable TabletPSN4ce98db3-c7a6-4627-88c5-9de302a531884
314221simethicone 125 MG Chewable TabletSCD4ce98db3-c7a6-4627-88c5-9de302a531884

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
17856-0137-2178560137021 TABLET, CHEWABLE in 1 POUCH (17856-0137-2) 2022-09-29NoNoCurrent