SIMETHICONE 80MG

Product NDC
55154-2606
11-digit product format
551542606
Labeler code
55154
Product ID
55154-2606_1c767028-e9e1-4b7b-8cf1-73497b854034
Type
HUMAN OTC DRUG
Nonproprietary name
SIMETHICONE
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-10-01
Substance
DIMETHICONE, UNSPECIFIED
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 80MG
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE, UNSPECIFIED80 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
5e755184-0821-4f92-8f72-84726f7aa407Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-2606-0SIMETHICONE 80MG1 in 1 BLISTER PACKTABLET, CHEWABLE13
55154-2606-0SIMETHICONE 80MG10 in 1 BAGTABLET, CHEWABLE103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-2606SIMETHICONE 80MG (SIMETHICONE) TABLET, CHEWABLE [CARDINAL HEALTH 107, LLC]1Current NDC, 2 package rows20241003_5e755184-0821-4f92-8f72-84726f7aa407.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 3 of 13 · 242 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gas ReliefSIMETHICONECVS PHARMACY, INC4ff77b4c-9616-4341-9bf8-eca301345a5f2026-05-21WarningsExact identifier
application number: M002
Phazyme UltimateSIMETHICONEC.B. Fleet Company, Inc.c8e9f6ac-2db2-4d21-a4b1-5ca6c31056622026-05-20WarningsExact identifier
application number: M002
gas reliefSIMETHICONEUnited Natural Foods, Inc. dba UNFI2a82a06d-7511-4fc0-b182-9c1774b2af482026-05-15WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONECVS PHARMACY, INCb114b07e-6822-465a-9e74-2a741ccb19f72026-05-14WarningsExact identifier
application number: M002
Firstcare Gas Relief Simethicone 250 mg Anti-gasSIMETHICONE 250 MGUSpharma Ltd9625a697-fadc-483b-b83a-fa2cc76002ba2026-05-12WarningsExact identifier
application number: M002
Firstcare Gas Relief Simethicone 125 mg Anti-gasSIMETHICONE 125 MGUSpharma Ltde92c9661-01f2-42be-af54-42e60efcae352026-05-12WarningsExact identifier
application number: M002
Recuren Plus Antifungal CreamMICONAZOLE NITRATE 2%REGENEREN PLUS LTD3c28a93a-dd42-65b8-e063-6294a90ae6ab2026-05-07WarningsExact identifier
application number: M002
mylanta gasSIMETHICONEInfirst Healthcarece925db4-fe1a-4069-96be-ce86cdd4e79a2026-05-01WarningsExact identifier
application number: M002
PHAZYMESIMETHICONEC.B. Fleet Company, Inc.3bb5cc1f-554b-4a4d-b9e9-665e34924b4b2026-04-29WarningsExact identifier
application number: M002
Childrens Emetrol Multi Symptom Upset Stomach ReliefCHILDRENS EMETROL MULTI-SYMPTOM UPSET STOMACH RELIEFWellSpring Pharmaceutical Corporationfe9ccc29-3cca-4666-9bb5-abb41816b3f52026-04-23WarningsExact identifier
application number: M002
Little Remedies Gas Relief DropsSIMTHICONEMedtech Products Inc.874d3f1d-1e4a-49ab-8285-4d6bf2601d5e2026-04-23WarningsExact identifier
application number: M002
good sense gas reliefSIMETHICONEPreferred Pharmaceuticals Inc.06836246-9058-42af-a8a3-5aec81f4b9cc2026-04-20WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONEWalgreens52cceb6b-f2c8-49bf-b5ce-5d1c999a9b602026-04-17WarningsExact identifier
application number: M002
Gas Relief Extra StrengthSIMETHICONEBest Choice (Valu Merchandisers Company)ce18af91-1c60-44b1-aed2-4f54d394e27e2026-04-13WarningsExact identifier
application number: M002
Gas Relief Extra StrengthSIMETHICONEH E Bc153585f-0f44-40ad-8246-5d9edae8325e2026-04-02WarningsExact identifier
application number: M002
ultra strength gas reliefSIMETHICONEBIONPHARMA INC.4e6ac834-9ce3-1b54-e063-6294a90a9dff2026-04-01WarningsExact identifier
application number: M002
Extra Strength Gas Relief CherrySIMETHICONEGood Sense (Geiss, Destin & Dunn, Inc.)91f72cf2-297d-48db-8f05-f8a7050d92e82026-03-31WarningsExact identifier
application number: M002
Extra Strength Gas ReliefSIMETHICONEHyvee Inc44ea37b1-8cd2-936d-e063-6394a90a2be72026-03-27WarningsExact identifier
application number: M002
Extra Strength Gas ReliefSIMETHICONEGrocery Outlet, Inc.44672e28-3305-a8cc-e063-6394a90a5fef2026-03-23WarningsExact identifier
application number: M002
gas reliefSIMETHICONEBIONPHARMA INC.4d7a9507-6f3c-6d15-e063-6294a90a01602026-03-20WarningsExact identifier
application number: M002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314216simethicone 80 MG Chewable TabletPSN5e755184-0821-4f92-8f72-84726f7aa4073
314216simethicone 80 MG Chewable TabletSCD5e755184-0821-4f92-8f72-84726f7aa4073

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55154-2606-05515426060010 BLISTER PACK in 1 BAG (55154-2606-0) / 1 TABLET, CHEWABLE in 1 BLISTER PACK10 blister pack2024-10-01NoNoCurrent