SIMETHICONE INFANT

Product NDC
17856-1017
Requested package NDC
17856-1017-2
11-digit product format
178561017
Labeler code
17856
Product ID
17856-1017_4d4f1d08-e4ba-c0bc-e063-6294a90ae949
Type
HUMAN OTC DRUG
Nonproprietary name
Simethicone
Dosage form
SUSPENSION
Route
ORAL
Labeler
Atlantic Biologicals Corp.
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
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
SIMETHICONE INFANT
Brand name suffix
Gas Relief Drops
Listing expiration
2027-12-31

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
410d80fc-e55b-08d0-e063-6294a90aba73Available 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
17856-1017-1SIMETHICONE INFANTGas Relief Drops120 in 1 CASESUSPENSION1204
17856-1017-1SIMETHICONE INFANTGas Relief Drops0.3 mL in 1 SYRINGESUSPENSION0.34
17856-1017-2SIMETHICONE INFANTGas Relief Drops120 in 1 CASESUSPENSION1204
17856-1017-2SIMETHICONE INFANTGas Relief Drops0.3 mL in 1 SYRINGESUSPENSION0.34
17856-1017-3SIMETHICONE INFANTGas Relief Drops120 in 1 CASESUSPENSION1204
17856-1017-3SIMETHICONE INFANTGas Relief Drops0.6 mL in 1 SYRINGESUSPENSION0.64
17856-1017-4SIMETHICONE INFANTGas Relief Drops120 in 1 CASESUSPENSION1204
17856-1017-4SIMETHICONE INFANTGas Relief Drops0.6 mL in 1 SYRINGESUSPENSION0.64
17856-1017-5SIMETHICONE INFANTGas Relief Drops60 in 1 CASESUSPENSION604
17856-1017-5SIMETHICONE INFANTGas Relief Drops1.2 mL in 1 SYRINGESUSPENSION1.24
17856-1017-6SIMETHICONE INFANTGas Relief Drops48 in 1 CASESUSPENSION484
17856-1017-6SIMETHICONE INFANTGas Relief Drops5 mL in 1 SYRINGESUSPENSION54
17856-1017-7SIMETHICONE INFANTGas Relief Drops0.6 mL in 1 SYRINGESUSPENSION0.64
17856-1017-7SIMETHICONE INFANTGas Relief Drops60 in 1 CASESUSPENSION604
17856-1017-8SIMETHICONE INFANTGas Relief Drops2 mL in 1 SYRINGESUSPENSION24
17856-1017-8SIMETHICONE INFANTGas Relief Drops120 in 1 CASESUSPENSION1204
17856-1017-9SIMETHICONE INFANTGas Relief Drops120 in 1 CASESUSPENSION1204
17856-1017-9SIMETHICONE INFANTGas Relief Drops0.6 mL in 1 SYRINGESUSPENSION0.64

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-1017-1EA - Each17856-1017ebe70b27-e6fb-4d60-9526-940fc2e4059a12026-05-22
17856-1017-2EA - Each17856-1017d6c55492-0ce1-4cd8-826f-e45ae0ff4c2612026-05-22
17856-1017-3EA - Each17856-1017c62edcbd-61af-48fc-af3a-8c02ebd6a19912026-05-22
17856-1017-4EA - Each17856-101799fc4c34-f849-4b7a-a912-bb860be6ab3d12026-05-22
17856-1017-5ML - Milliliter17856-1017e8f96a2d-2f37-4778-a4bf-7952cabfca4612026-05-22
17856-1017-6ML - Milliliter17856-1017cf487585-74b4-4acf-96e1-16063eddd6bd12026-05-22
17856-1017-7EA - Each17856-1017d4f91bd2-05ff-4e2e-8a2d-557ac2cdee6912026-05-22
17856-1017-8ML - Milliliter17856-1017d0e249a0-db63-4158-bf3b-e840057806b712026-05-22

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 4 of 13 · 242 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gas Relief Extra StrengthSIMETHICONEEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)ea6e04dd-4f57-4a88-b269-af38732915b32026-03-19WarningsExact identifier
application number: M002
SIMETHICONE INFANT Gas Relief DropsSIMETHICONEAtlantic Biologicals Corp.4d658287-358f-d358-e063-6294a90a4bd32026-03-19WarningsExact identifier
application number: M002
SIMETHICONE INFANT Gas Relief DropsSIMETHICONEAtlantic Biologicals Corp.410d80fc-e55b-08d0-e063-6294a90aba732026-03-18WarningsExact identifier
application number: M002
ndc (package): 17856-1017-2
ndc (product): 17856-1017
ndc11 (package): 17856101702
Gas Relief Extra StrengthSIMETHICONEWalgreensafcabb34-4ef4-4938-860f-154c204fcd482026-03-10WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONE 125 MGPioneer Life Sciences, LLC2c7bac92-4596-40aa-a2f2-4ebe380f1f2f2026-03-10WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONE 125 MGPioneer Life Sciences, LLC51dc6493-2f9f-4148-be7d-abfef1b251122026-03-10WarningsExact identifier
application number: M002
Gas Relief Extra StrengthSIMETHICONETOP CARE (Topco Associates LLC)ed8a723a-7dac-4670-8f02-f4154e0a36c92026-03-02WarningsExact identifier
application number: M002
Extra Strength Gas ReliefSIMETHICONEShield Pharmaceuticals Corpfafb57da-0682-475e-8ff9-17f2182129ef2026-02-24WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONE 180 MGPioneer Life Sciences, LLCf5284b68-f167-41d4-8b2f-ae7bafae0f4c2026-02-13WarningsExact identifier
application number: M002
SFEIXE ANTIFUNGAL PENUNDECYLENIC ACIDZhejiang JOOZENA Medical Technology Co., Ltd.455ad304-86bc-0abe-e063-6294a90a5b432026-02-12WarningsExact identifier
application number: M002
Gas Relief Ultimate Strength SoftgelsSIMETHICONEAdvanced Rx LLC5d412711-efd3-4b27-bfde-6fee2f460f8b2026-02-01WarningsExact identifier
application number: M002
QUITA COLICOS Gas RELIEF DropsSIMETHICONEDLC Laboratories, Inc.d4b0fa36-5925-4a6f-b3c9-0c785503976f2026-01-07WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONESafeway, Inc.7ecfe412-6a58-4dff-a52e-2e02a03426f92026-01-05WarningsExact identifier
application number: M002
Simethicone 180 MGSIMETHICONE 180 MGFarmacias De Similares TX LLC4b2166f7-8d98-dd76-e063-6394a90a7f0f2026-01-01WarningsExact identifier
application number: M002
Target Gas Relief Chews Mixed Berry and StrawberrySIMETHICONETarget11fd2ccd-3a2b-c141-e063-6394a90ab34f2025-12-20WarningsExact identifier
application number: M002
Gas Relief Simethicone 125mg SoftgelSIMETHICONENUVICARE LLCb774c8e6-e68e-4a13-834d-7eba34c5c3e02025-12-19WarningsExact identifier
application number: M002
Gas Relief Simethicone 180mg SoftgelSIMETHICONENUVICARE LLC51484644-eb45-4282-91c6-289169bcbaf62025-12-19WarningsExact identifier
application number: M002
EXTRA STRENGTH gas reliefSIMETHICONEKRAMER LABORATORIESd45ec9d0-f8b9-41ef-8dd9-11caf6a1b3eb2025-12-19WarningsExact identifier
application number: M002
SIMETHICONE 80MGSIMETHICONECardinal Health 107, LLC5e755184-0821-4f92-8f72-84726f7aa4072025-12-18WarningsExact identifier
application number: M002
Gas ReliefSIMETHICONE CAPSULES USP, 125 MGDr. Reddy's Laboratories Inc.b3069d83-5654-8469-302a-0f76c30e39762025-12-15WarningsExact 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
17856-1017-217856101702120 SYRINGE in 1 CASE (17856-1017-2) / .3 mL in 1 SYRINGE120 syringe2025-10-13NoNoCurrent