FDA.reportPublic FDA data

NDC 17856-1017-01 - SIMETHICONE INFANT Gas Relief Drops

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
17856-1017
Requested NDC
17856-1017-01
Package NDCs from labels
17856-1017-1, 17856-1017-2, 17856-1017-3, 17856-1017-4, 17856-1017-5, 17856-1017-6, 17856-1017-7, 17856-1017-8, 17856-1017-9, 17856-1017-01
Manufacturer
Atlantic Biologicals Corp.
Effective date
2026-03-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
SIMETHICONE INFANT GAS RELIEF DROPS fast instant gas reliefAtlantic Biologicals Corp.2026-03-18HUMAN OTC DRUG LABEL

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 49 of 51 · 1,015 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERMedical Purchasing Solutions, LLCe90b47e3-9636-b9ee-e053-2a95a90ad48c2022-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
REFRESH OPTIVE AdvancedCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.ebd0839e-2e1d-4e0e-986c-19f1f5c763582022-09-15WarningsExact identifier
unii: K679OBS311
Loperamide Hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE AND SIMETHICONECamber Consumer Care Ince2a4af66-1d05-408c-9f11-f2a9f325d75c2022-09-12WarningsExact identifier
unii: 92RU3N3Y1O
REFRESH OPTIVE AdvancedCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80Allergan, Inc.aaa943e4-7c38-4c5a-b7c0-5a656d8cafc02022-09-01WarningsExact identifier
unii: K679OBS311
Loperamide HCl and SimethiconeLOPERAMIDE HCL AND SIMETHICONEOhm Laboratories Inc.06f99f59-e702-49f1-bb1d-e7cf58c54c302022-08-30WarningsExact identifier
unii: 92RU3N3Y1O
REFRESH TEARSCARBOXYMETHYLCELLULOSE SODIUMAllergan, Inc.329d1fe0-4432-4565-b7b1-65666bd865262022-06-30WarningsExact identifier
unii: K679OBS311
REFRESH Optive Mega-3CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80Allergan, Inc.c5f2b3f2-2071-45bd-a010-67f848bc02332022-06-30WarningsExact identifier
unii: K679OBS311
REFRESH PLUSCARBOXYMETHYLCELLULOSE SODIUMAllergan, Inc.0f6a4b4b-cde6-4518-84b5-ce997f1154a72022-06-28WarningsExact identifier
unii: K679OBS311
Sterile WaterWATERFresenius Kabi USA, LLCf42ac50f-0ec5-4713-a4c8-99d972d90bed2022-06-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCe71c6c83-d518-496c-b2ab-efd5987e47832022-06-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
AddiclenzBETA VULGARIS, BOLDO, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDeseret Biologicals, Inc.e39235ea-2a2f-44a7-92d6-fb1d428ebabd2022-05-12WarningsExact identifier
unii: OJ245FE5EU
Bio Co-Enzyme PhaseBETA VULGARIS, ASCORBICUM ACIDUM, CYSTEINUM, NATRUM OXALACETICUM, NICOTINAMIDUM, PULSATILLA (PRATENSIS), PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, THIAMINUM HYDROCHLORICUM, ALPHA-KETOGLUTARICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CERIUM OXALICUM, CITRICUM ACIDUM, FUMARICUM ACIDUM, MAGNESIUM OROTICUM DIHYDRICUM, MALICUM ACIDUM, NADIDUM, NATRUM PYRUVICUM, PANTOTHENIC ACID, SUCCINICUM ACIDUM, ADRENALINUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, HEPAR SULPHURIS CALCAREUM, SULPHUR, ACONITICUM ACIDUM, CIS-,Deseret Biologicals, Inc.e8f6e2ec-ae2e-4bee-b9d3-5f3a2e3daf652022-05-09WarningsExact identifier
unii: XF417D3PSL
ACD Blood-Pack Units (PL 146 PLASTIC)ANTICOAGULANT CITRATE DEXTROSE (ACD)Fenwal, Inc.ba894daa-688e-4a9e-bd74-e71797f951bb2022-04-27Exact identifier
unii: XF417D3PSL
ACD-AANTICOAGULANT CITRATE DEXTROSE SOLUTION FORMULA AFenwal, Inc.22805f0d-ba58-41ea-b245-19980abcda222022-02-11Exact identifier
unii: XF417D3PSL
Sterile WaterWATERAmerican Regent, Inc.78b35864-4bbc-4759-a5c1-7e4f25e229322022-01-31Boxed warningExact identifier
unii: 059QF0KO0R
Sterile Diluent for TreprostinilWATERDr.Reddy's Laboratories Inc.,33050ee2-519b-1f0b-d4df-9e14dd329c572021-12-23Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.d763511e-f1a7-4014-94b9-f7ad8f023ff42021-12-02Exact identifier
unii: XF417D3PSL
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.cf9f43a0-c750-4cf0-ac49-176ab2105aab2021-12-02Exact identifier
unii: XF417D3PSL
Gas ReliefSIMETHICONEAllegiant Healthae98861e-6a26-4e0e-a66a-b2738d3cbddd2021-09-24WarningsExact identifier
application number: M002
unii: 92RU3N3Y1O
Gas ReliefSIMETHICONEAllegiant Health4c79535c-4372-4fd4-a91a-d93617cd581b2021-09-24WarningsExact identifier
application number: M002
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.