FDA.reportPublic FDA data

SIMETHICONE INFANT

Product NDC
17856-1017
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 9 of 13 · 242 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Simethicone Certified PlusSIMETHICONEAdvance Pharmaceutical Inc.d087743f-b82f-2a5c-e053-2995a90abb202024-12-26WarningsExact identifier
application number: M002
GNP Regular Strength Gas ReliefDIMETHICONEAmerisource Bergen7b63b265-e4f2-4103-935c-22d2d89cc5e82024-12-26WarningsExact identifier
application number: M002
Infants Gas reliefSIMETHICONETopco Associates, LLCfd6a2537-8db2-492d-b045-6404df2fb9c32024-12-26WarningsExact identifier
application number: M002
Equaline Stomach ReliefBISMUTH SUBSALICYLATEUNITED NATURAL FOODS, INC. DBA UNFI5dae8bbe-219b-4aa1-bf7f-6471fa2856d92024-12-20WarningsExact identifier
application number: M002
GNP Stomach ReliefBISMUTH SUBSALICYLATE 525 MGAmerisource Bergenead13b6b-de37-49f9-b18e-68096651d47e2024-12-20WarningsExact identifier
application number: M002
Infants Gas reliefSIMETHICONEUNITED NATURAL FOODS, INC. DBA UNFIa9902ba0-f239-4e66-8d66-7cef39a5fdc32024-12-20WarningsExact identifier
application number: M002
GNP Pink BismuthBISMUTH SUBSALICYLATEAmerisource Bergena6ed50d5-574f-4d6b-be48-e146593389932024-12-20WarningsExact identifier
application number: M002
WinCo Foods Gas Relief Extra Strength SoftgelsSIMETHICONEWinCo Foods, LLCa1a19ef7-4a14-4fcb-8917-631d867be0bb2024-12-18WarningsExact identifier
application number: M002
Discount Drugmart Gas Relief Extra Strength SoftgelsSIMETHICONEDiscount Drug Mart, Inc63f3e5f0-10da-4681-a4f1-8ca1eb7e390f2024-12-18WarningsExact identifier
application number: M002
Quality Choice Gas Relief Extra Strength SoftgelsSIMETHICONEChain Drug Marketing Association06dfb541-fd1f-4cee-a4a6-44252f1f65a02024-12-18WarningsExact identifier
application number: M002
Leader Gas reliefSIMETHICONECARDINAL HEALTH 110, LLC. DBA LEADER0163d372-222e-4a8d-a5cb-5a7af9a7068c2024-12-17WarningsExact identifier
application number: M002
Maximum Strength Gas Relief Softgel-60ctSIMETHICONEHEBf65e362a-2f90-428a-b885-eefdad8cae1e2024-12-16WarningsExact identifier
application number: M002
Maximum Strength Gas ReliefSIMETHICONEChain Drug Marketing Association, Inc.e8b2c528-121d-519a-e053-2a95a90a41192024-12-16WarningsExact identifier
application number: M002
Gas Relief Ultra StrengthDIMETHICONETOPCO ASSOCIATES LLCb9a4c876-722b-4d6c-807f-005ccf5df3202024-12-14WarningsExact identifier
application number: M002
Gas Relief Extra StrengthDIMETHICONETOPCO ASSOCIATES LLCbb1c54d4-3a36-4b77-8659-2e92845d2f0e2024-12-14WarningsExact identifier
application number: M002
Foster and Thrive Extra Strength Gas Relief CherrySIMETHICONEStrategic Sourcing Services LLCe47374c8-05c1-4874-871b-e83d9b305bd32024-12-13WarningsExact identifier
application number: M002
Gas-X Extra StrengthSIMETHICONEHaleon US Holdings LLC7ce312ca-542b-4bc0-97b5-f65279e1e84c2024-12-13WarningsExact identifier
application number: M002
Antacid AntigasALUMINUM HYDROXIDE, MAGNESIUM HYDROXIDE, SIMETHICONERetail Business Services, LLC.c8173d42-f900-4527-aa56-472d1177a9bc2024-12-11WarningsExact identifier
application number: M002
SimethiconeSIMETHICONEHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd0c9c5fec-ddd4-41a5-8ff9-6b55c376dd362024-11-25WarningsExact identifier
application number: M002
SimethiconeSIMETHICONEHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.f7c40b12-11e4-4b85-afb2-0ea33e4f218c2024-11-25WarningsExact 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
17856-1017-117856101701120 SYRINGE in 1 CASE (17856-1017-1) / .3 mL in 1 SYRINGE120 syringe2025-10-13NoNoCurrent
17856-1017-217856101702120 SYRINGE in 1 CASE (17856-1017-2) / .3 mL in 1 SYRINGE120 syringe2025-10-13NoNoCurrent
17856-1017-317856101703120 SYRINGE in 1 CASE (17856-1017-3) / .6 mL in 1 SYRINGE120 syringe2025-10-13NoNoCurrent
17856-1017-417856101704120 SYRINGE in 1 CASE (17856-1017-4) / .6 mL in 1 SYRINGE120 syringe2025-10-13NoNoCurrent
17856-1017-51785610170560 SYRINGE in 1 CASE (17856-1017-5) / 1.2 mL in 1 SYRINGE60 syringe2025-10-13NoNoCurrent
17856-1017-61785610170648 SYRINGE in 1 CASE (17856-1017-6) / 5 mL in 1 SYRINGE48 syringe2025-10-13NoNoCurrent
17856-1017-71785610170760 SYRINGE in 1 CASE (17856-1017-7) / .6 mL in 1 SYRINGE60 syringe2025-12-18NoNoCurrent
17856-1017-817856101708120 SYRINGE in 1 CASE (17856-1017-8) / 2 mL in 1 SYRINGE120 syringe2025-12-18NoNoCurrent
17856-1017-917856101709120 SYRINGE in 1 CASE (17856-1017-9) / .6 mL in 1 SYRINGE120 syringe2026-03-18NoNoCurrent