FDA.reportPublic FDA data

Mommy's Bliss Gas Relief Simethicone Drops

Manufacturer
MOM Enterprises, LCC
Effective date
2024-04-09
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:10:50

Label at a glance#

Productsimethicone gas relief
Active ingredientDIMETHICONE
Label structure9 sections

Label contents#

Full prescribing information#

Mommy's Bliss Gas Relief Simethicone Drops GD-4 Drug Facts panel

OTC - ACTIVE INGREDIENT SECTION

Drug Facts PanelDrug Facts Panel

Inactive Ingredients

INACTIVE INGREDIENT SECTION

inactive ingredientsinactive ingredients

Mommy's Bliss Gas Relief Simethicone Drops GD-4 Romance Panel

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.Keep out of reach of children.

Mommy's Bliss Gas Relief Simethicone Drops GD-4 bottle label

OTC - PURPOSE SECTION

bottle labelbottle label

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

drug factsdrug facts

warnings and precautions

WARNINGS AND PRECAUTIONS SECTION

warningswarnings

Indicators & Usage

INDICATIONS & USAGE SECTION

indicatorsindicators

Warnings

WARNINGS SECTION

warningswarnings

Mommy's bliss Gas Relief Simethicon Drops GD-4 Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198857simethicone 20 MG in 0.3 mL Oral SuspensionPSN7
198857simethicone 66.7 MG/ML Oral SuspensionSCD7
198857simethicone 20 MG per 0.3 ML Oral SuspensionSY7
198857simethicone 40 MG per 0.6 ML Oral SuspensionSY7

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71444-788-01simethicone gas relief30 mL in 1 BOTTLE, DROPPERSUSPENSION/ DROPS307
71444-788-01simethicone gas relief1 in 1 CARTONSUSPENSION/ DROPS17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71444-788SIMETHICONE GAS RELIEF (SIMETHICONE) SUSPENSION/ DROPS [MOM ENTERPRISES, LCC]7Current NDC, 2 package rows20240410_536ecfdf-7124-502a-e054-00144ff8d46c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71444-78871444-788-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
GINGERC5529G5JPQIACT
STEVIA LEAF6TC6NN0876IACT
POTASSIUM SORBATE1VPU26JZZ4IACT
DIMETHICONE92RU3N3Y1OACTIB
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYSORBATE 60CAL22UVI4MIACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBITOL506T60A25RIACT
XANTHAN GUMTTV12P4NEEIACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
simethicone gas reliefSIMETHICONEMOM Enterprises, LCC536ecfdf-7124-502a-e054-00144ff8d46c2024-04-09WarningsExact identifier
ndc (package): 71444-788-01
ndc (product): 71444-788
ndc11 (package): 71444078801
spl id: 15ad0793-046c-49ff-e063-6394a90a301b
spl set id: 536ecfdf-7124-502a-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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