FDA.reportPublic FDA data

SIMETHICONE INFANT

Product NDC
82568-0017
11-digit product format
825680017
Labeler code
82568
Product ID
82568-0017_3b14f103-c7f9-f905-e063-6294a90a0e2c
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
SUSPENSION
Route
ORAL
Labeler
AARNA USA Inc.
Application
M002
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-02-20
Substance
DIMETHICONE
Active strength
20 mg/.3mL
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 INFANT
Brand name suffix
Gas Relief Drops
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE20 mg/.3mL

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
198857Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9b0fde90-35ae-498e-99cc-d120f1a87182Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82568-0017-3SIMETHICONE INFANTGas Relief Drops1 in 1 PACKAGESUSPENSION13
82568-0017-3SIMETHICONE INFANTGas Relief Drops30 mL in 1 BOTTLESUSPENSION303
82568-0017-4SIMETHICONE INFANTGas Relief Drops118 mL in 1 BOTTLESUSPENSION1183

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82568-0017-3ML - Milliliter82568-0017b5bb14da-65f2-41ba-89f9-e1555f0e1b5612025-10-14
82568-0017-4ML - Milliliter82568-0017c1386582-32de-40f1-8f29-0a70ca9eb35e12025-11-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82568-0017SIMETHICONE INFANT GAS RELIEF DROPS (SIMETHICONE) SUSPENSION [AARNA USA INC.]1Current NDC, 3 package rows20250303_9b0fde90-35ae-498e-99cc-d120f1a87182.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
198857simethicone 20 MG in 0.3 mL Oral SuspensionPSN410d80fc-e55b-08d0-e063-6294a90aba734
198857simethicone 66.7 MG/ML Oral SuspensionSCD410d80fc-e55b-08d0-e063-6294a90aba734
198857simethicone 20 MG per 0.3 ML Oral SuspensionSY410d80fc-e55b-08d0-e063-6294a90aba734
198857simethicone 40 MG per 0.6 ML Oral SuspensionSY410d80fc-e55b-08d0-e063-6294a90aba734
198857simethicone 20 MG in 0.3 mL Oral SuspensionPSN9b0fde90-35ae-498e-99cc-d120f1a871823
198857simethicone 66.7 MG/ML Oral SuspensionSCD9b0fde90-35ae-498e-99cc-d120f1a871823
198857simethicone 20 MG per 0.3 ML Oral SuspensionSY9b0fde90-35ae-498e-99cc-d120f1a871823
198857simethicone 40 MG per 0.6 ML Oral SuspensionSY9b0fde90-35ae-498e-99cc-d120f1a871823
198857simethicone 20 MG in 0.3 mL Oral SuspensionPSN4d658287-358f-d358-e063-6294a90a4bd31
198857simethicone 66.7 MG/ML Oral SuspensionSCD4d658287-358f-d358-e063-6294a90a4bd31
198857simethicone 20 MG per 0.3 ML Oral SuspensionSY4d658287-358f-d358-e063-6294a90a4bd31
198857simethicone 40 MG per 0.6 ML Oral SuspensionSY4d658287-358f-d358-e063-6294a90a4bd31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82568-0017-3825680017031 BOTTLE in 1 PACKAGE (82568-0017-3) / 30 mL in 1 BOTTLE1 bottle2025-02-20NoNoCurrent
82568-0017-482568001704118 mL in 1 BOTTLE (82568-0017-4) 118 ml2025-02-20NoNoCurrent